Hong Kong, Shanghai, & Florham Park, NJ — Friday, December 29, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) hereby notifies the market that as at December 29, 2023, the issued share capital of HUTCHMED consisted of 871,256,270 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury.
The above figure of 871,256,270 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, HUTCHMED under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.
For illustrative purposes only, the 871,256,270 ordinary shares would be equivalent to 871,256,270 depositary interests (each equating to one ordinary share) which are traded on AIM or, if the depositary interests were converted in their entirety, equivalent to 174,251,254 American depositary shares (each equating to five ordinary shares) which are traded on Nasdaq.
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S.. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
Contacts
| Investor Enquiries | +852 2121 8200 / +1 973 306 4490 / ir@hutch-med.com |
| Media Enquiries | |
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
| Nominated Advisor | |
| Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon | +44 (20) 7886 2500 |
Hong Kong, Shanghai, & Florham Park, NJ — Friday, December 29, 2023: HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM: HCM; HKEX: 13) announces the following blocklisting six monthly return:
| 1. | Name of applicant: | HUTCHMED (China) Limited | ||
| 2. | Name of scheme: | (a) | Share Option Scheme conditionally adopted by HUTCHMED in 2005 (“2005 HUTCHMED Share Option Scheme”) | |
| (b) | Share Option Scheme conditionally adopted by HUTCHMED in 2015 (“2015 HUTCHMED Share Option Scheme”) | |||
| 3. | Period of return: | From June 29, 2023 to December 28, 2023 | ||
| 4. | Balance under scheme from previous return: | (a) | 2005 HUTCHMED Share Option Scheme: 434,050 ordinary shares of US$0.1 each | |
| (b) | 2015 HUTCHMED Share Option Scheme: 51,730,718 ordinary shares of US$0.1 each | |||
| 5. | The amount by which the block scheme has been increased, if the scheme has been increased since the date of the last return: | (a) | 2005 HUTCHMED Share Option Scheme: Nil | |
| (b) | 2015 HUTCHMED Share Option Scheme: Nil | |||
| 6. |
Number of securities issued/allotted under scheme during period:
|
(a) | 2005 HUTCHMED Share Option Scheme: 211,320 | |
| (b) | 2015 HUTCHMED Share Option Scheme: 4,883,500 | |||
| 7. | Balance under scheme not yet issued/allotted at end of the period: | (a) | 2005 HUTCHMED Share Option Scheme: 222,730 ordinary shares of US$0.1 each (Note: All granted share options have been exercised) | |
| (b) | 2015 HUTCHMED Share Option Scheme: 46,847,218 ordinary shares of US$0.1 each | |||
| 8. | Number and class of securities originally listed and the date of admission: | 25,198,880 ordinary shares of US$0.1 each admitted on June 17, 2019 (to replace the Company’s previous block admission schemes following the Company’s share subdivision which took effect on May 30, 2019) | ||
| 9. | Total number of securities in issue at the end of the period: | 871,256,270 ordinary shares of US$0.1 each | ||
| Name of contact | Weiguo Su | |||
| Address of contact: | Level 18, The Metropolis Tower, 10 Metropolis Drive, Hung Hom, Kowloon, Hong Kong | |||
| Telephone number of contact: | +852 2121 8200 | |||
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
| Investor Enquiries | +852 2121 8200 / +1 973 306 4490 / ir@hutch-med.com |
| Media Enquiries | |
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
| Nominated Advisor | |
| Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon | +44 (20) 7886 2500 |
In anticipation of the expiration of the initial terms of the Framework Sinopharm Products Supply and Purchase Agreement and the HBYS Brand License Royalty Agreement on December 31, 2023, on December 21, 2023:
IMPLICATIONS UNDER THE LISTING RULES
(1) Framework Sinopharm Products Supply and Purchase Agreement
As Sinopharm is a substantial shareholder of a subsidiary of the Company, it is a connected person of the Company and the supply to and purchase from Sinopharm of products by the Group constitute continuing connected transactions of the Company under Chapter 14A of the Listing Rules.
In relation to each of (i) the supply of products by the Group and (ii) the purchase of products by the Group, the highest applicable percentage ratio in respect of each of the Annual Cap Amounts exceeds 5%. As the transactions are between the Group and a connected person at the subsidiary level and are on normal commercial terms, the Directors have approved the transactions and the independent non-executive Directors have given the confirmation required under Rule 14A.101 of the Listing Rules, (i) the supply of products by the Group and (ii) the purchase of products by the Group under the Framework Sinopharm Products Supply and Purchase Agreement are subject to the reporting, announcement and annual review requirements, but are exempt from the circular, independent financial advice and independent shareholders’ approval requirements under Chapter 14A of the Listing Rules.
(2) HBYS Brand License Royalty Agreement
As HWEL is a subsidiary of CK Hutchison, it is a connected person of the Company by virtue of being an associate of a substantial shareholder of the Company and the license granted under the HBYS Brand License Royalty Agreement constitute continuing connected transactions of the Company under Chapter 14A of the Listing Rules.
As the highest applicable percentage ratio in respect of the annual fee payable by HCMH under the HBYS Brand License Royalty Agreement, on an annual basis, exceeds 0.1% but is less than 5%, the transactions contemplated under the HBYS Brand License Royalty Agreement are subject to the reporting, announcement and annual review requirements, but are exempt from the circular, independent financial advice and independent shareholders’ approval requirements under Chapter 14A of the Listing Rules.
CONTINUING CONNECTED TRANSACTIONS
A. FRAMEWORK SINOPHARM PRODUCTS SUPPLY AND PURCHASE AGREEMENT
In the ordinary course of business, Hutchison Sinopharm (i) supplies prescription drugs to Sinopharm and/or its associates and (ii) purchases prescription drugs from Sinopharm and/or its associates in accordance with the terms and conditions of the Framework Sinopharm Products Supply and Purchase Agreement.
(1) Principal terms
In anticipation of the expiration of the initial term of the Framework Sinopharm Products Supply and Purchase Agreement on December 31, 2023, on December 21, 2023, the Company and Sinopharm agreed to renew the Framework Sinopharm Products Supply and Purchase Agreement with effect from January 1, 2024 for a period of three years up to and including December 31, 2026. All other terms and conditions of the Framework Sinopharm Products Supply and Purchase Agreement remain unchanged, the principal terms of which are set out below:
(a) Subject matter
The parties agreed that at any time during the term of the Framework Sinopharm Products Supply and Purchase Agreement, the relevant members of the Group and Sinopharm and/or its associates may from time to time enter into definitive agreements in relation to any transactions relating to (i) supply of products by the Group to Sinopharm and/or its associates and (ii) purchase of products by the Group from Sinopharm and/or its associates upon, and subject to, the terms and conditions in compliance with the Framework Sinopharm Products Supply and Purchase Agreement as may be agreed between the relevant parties.
(b) Duration
Three years up to and including December 31, 2026, unless terminated earlier by either party giving not less than one month’s prior written notice or otherwise in accordance with the terms of the Framework Sinopharm Products Supply and Purchase Agreement.
(c) Consideration and other terms
The Framework Sinopharm Products Supply and Purchase Agreement provides that all transactions thereunder must be conducted (i) in the ordinary and usual course of business of the Group, (ii) on an arm’s length basis, (iii) on normal commercial terms with the supply price and/or purchase price (as the case may be) being determined with reference to fixed unit prices which are negotiated on an arm’s length basis and (iv) in compliance with, amongst other things, the Listing Rules and applicable laws.
(2) Historical transaction amounts
The aggregate transaction amount recorded by the Group for the supply of products by the Group to Sinopharm and/or its associates for the financial years ended December 31, 2021 and 2022 and the ten months ended October 31, 2023 are as follows:
| FY2021 | FY2022 | Ten months ended October 31, 2023 | |
| Aggregate transaction amount | US$55.7 million | US$69.4 million | US$84.8 million |
The aggregate transaction amount paid by the Group to Sinopharm and/or its associates for the purchase of products by the Group for the financial years ended December 31, 2021 and 2022 and the ten months ended October 31, 2023 are as follows:
| FY2021 | FY2022 | Ten months ended October 31, 2023 | |
| Aggregate transaction amount | US$2.6 million | US$2.4 million | US$3.3 million |
(3) Annual Cap Amounts
In relation to the supplying of products by the Group, it is expected that the maximum annual transaction amount receivable by the Group from Sinopharm and/or its associates for the three financial years ending December 31, 2024, 2025 and 2026 will not exceed the amounts set out below:
| FY2024 | FY2025 | FY2026 | |
| Aggregate transaction amount | US$498.0 million | US$920.8 million | US$1,310.6 million |
The annual cap amounts in respect of the supplying of products by the Group were determined by reference to (i) the historical transaction amounts, (ii) the estimated increase in sales of existing oncology marketed products through deeper market penetration and broader market coverage from the potential new indication of fruquintinib for gastric cancer which is at NDA review stage in China, (iii) the estimated new contribution of commercial sales from potential launch of new assets such as sovleplenib and amdizalisib starting in FY2024, (iv) the estimated increase in overall sales of existing prescription drugs from the potential expansion of product portfolio and distribution channels such as private hospitals and drugstores, and (v) the estimated new contribution of commercial sales from new products acquired through potential business development activities such as partnerships, in-licensings and acquisitions.
In relation to the purchase of products by the Group, it is expected that the maximum annual transaction amount payable by the Group to Sinopharm and/or its associates for the three financial years ending December 31, 2024, 2025 and 2026 will not exceed the amounts set out below:
| FY2024 | FY2025 | FY2026 | |
| Aggregate transaction amount | US$10.0 million | US$20.0 million | US$30.0 million |
The annual cap amounts in respect of the purchase of products by the Group were determined by reference to (i) the historical transaction amounts and historical growth in purchase volume resulting from the development of business with new hospital channels, (ii) the supply price for the products and (iii) the expected further increase in the purchase volume resulting from the development of business with new hospital channels and expansion of sales to such new hospital channels.
B. HBYS BRAND LICENSE ROYALTY AGREEMENT
HCMH and HWEL entered into the HBYS Brand License Royalty Agreement on June 15, 2021 pursuant to which HCMH will pay to HWEL an annual fee of HK$12 million (approximately US$1.5 million) in consideration of the grant of the royalty-free license by HWEL to Hutchison Baiyunshan (a former non-consolidated joint venture of the Company) and its subsidiary undertakings.
(1) Principal terms
In anticipation of the expiration of the initial term of the HBYS Brand License Royalty Agreement (as amended and restated) on December 31, 2023, on December 21, 2023, the Company and HCMH agreed to renew the HBYS Brand License Royalty Agreement with effect from January 1, 2024 for a period of three years up to and including December 31, 2026. All other terms and conditions of the HBYS Brand License Royalty Agreement remain unchanged, the principal terms of which are set out below:
(a) Subject matter
In consideration of the grant of the royalty-free right to use the HWL Trade Marks by HWEL to Hutchison Baiyunshan and its subsidiary undertakings, HCMH agrees to pay to HWEL an annual fee of HK$12 million.
(b) Duration
Three years up to and including 31 December 2026, unless terminated earlier in accordance with the terms of the HBYS Brand License Royalty Agreement.
(c) Termination and other terms
The HBYS Brand License Royalty Agreement will terminate upon (i) the change of name of Hutchison Baiyunshan and its subsidiary undertakings to names that do not include the “Hutchison Whampoa” names, (ii) the earlier of (a) the termination of the trade mark license agreements between HWEL (on the one hand) and Hutchison Baiyunshan and its subsidiary undertakings (on the other hand) and (b) the complete cessation of the use of the HWL Trade Marks by Hutchison Baiyunshan and its subsidiary undertakings and (iii) the termination of the HBYS SPA.
The aggregate fees payable by HCMH under the HBYS Brand License Royalty Agreement (including any renewal thereof) shall not be more than HK$120 million, even if the HBYS Brand License Royalty Agreement is not terminated and continues to be renewed after 10 years.
(2) Historical transaction amounts
The fees paid by HCMH to HWEL for the financial years ended December 31, 2021 and 2022 and the financial year ending December 31, 2023 are as follows:
| FY2021 | FY2022 | FY2023 | |
| Annual fee | HK$12 million | HK$12 million | HK$12 million |
(3) Annual Cap Amounts
The annual fee payable by HCMH under the HBYS Brand License Royalty Agreement for each financial year ending December 31, 2024, 2025 and 2026 will be HK$12 million.
The annual fee was determined by reference to (i) the historical sales volume of Hutchison Baiyunshan products and expected future growth, (ii) the portion of Hutchison Baiyunshan jointly branded products which uses the HWL Trade Marks and “Baiyunshan” trade marks, (iii) the expected future trend in and period of such use of the HWL Trade Marks in jointly branded products, (iv) market royalty rates for the use of a brand in a jointly branded product, and (v) arm’s length negotiation between the Group and HWEL.
C. REASONS FOR, AND THE BENEFITS OF, THE CONTINUING CONNECTED TRANSACTIONS
(1) Framework Sinopharm Products Supply and Purchase Agreement
Hutchison Sinopharm, a consolidated joint venture of the Company, focuses on providing logistics, distribution and marketing services for prescription drugs in China. As of December 31, 2022, Hutchison Sinopharm had a dedicated team of over 40 commercial staff that focus on marketing over 900 third-party prescription drug and other products directly to about 730 public and private hospitals in the Shanghai region and through a network of approximately 55 distributors to cover all other provinces in China.
As of December 31, 2022, Hutchison Sinopharm had over 860 customers of which approximately 13% were distributors, and the revenue generated from these distributors accounted for approximately 25% of the revenue of Hutchison Sinopharm for the year ended December 31, 2022.
The supply of products by Hutchison Sinopharm to Sinopharm, a leading distributor of pharmaceutical and healthcare products and a leading supply chain service provider in China, under the Framework Sinopharm Products Supply and Purchase Agreement, is in line with the business of Hutchison Sinopharm and enables Hutchison Sinopharm to utilize the distribution network of Sinopharm.
The purchase of products by Hutchison Sinopharm from Sinopharm under the Framework Sinopharm Products Supply and Purchase Agreement enables Hutchison Sinopharm to secure a stable source of the relevant products.
(2) The HBYS Brand License Royalty Agreement
On March 24, 2021, HBYSGH and GL Mountrose Investment Two Limited entered into the HBYS SPA pursuant to which HBYSGH agreed to sell the entire issued share capital of HCMGIL (which indirectly held 50% interest in Hutchison Baiyunshan) to GL Mountrose Investment Two Limited. To facilitate the HBYS Disposal, HBYSGH agreed pursuant to the HBYS SPA and as a condition to the completion of the HBYS Disposal that it would procure HWEL to continue to grant the relevant license to Hutchison Baiyunshan to use the HWL Trade Marks. In order to satisfy the condition and for HWEL to continue to grant the license, HCMH entered into the HBYS Brand License Royalty Agreement. The Group had taken into consideration the amount payable under the HBYS Brand License Royalty Agreement when the Group evaluated the commercial aspects of the HBYS Disposal. Please refer to the section headed “Connected Transactions – B. Non-Exempt Continuing Connected Transactions – 6. HBYS Brand License Royalty Agreement” in the prospectus of the Company dated June 18, 2021 for further details.
The term of the HBYS Brand License Royalty Agreement is renewed (i) as the HBYS Brand License Royalty Agreement has not been terminated according to its terms and (ii) as agreed by HBYSGH pursuant to the HBYS SPA, to procure HWEL to continue to grant the relevant license to Hutchison Baiyunshan.
(3) Views of the Directors
The Directors (including the independent non-executive Directors) are of the view that the Continuing Connected Transactions have been and will be entered into in the ordinary and usual course of business of the Group and on normal commercial terms, and their terms are fair and reasonable and in the interests of the Company and the Shareholders as a whole, and that the relevant Annual Cap Amounts for the Continuing Connected Transactions are fair and reasonable and in the interests of the Company and the Shareholders as a whole.
None of the Directors has any material interest in the Continuing Connected Transactions and no Director was required to abstain from voting on the board resolutions of the Company approving the Continuing Connected Transactions. Notwithstanding the foregoing, Mr To Chi Keung, Simon, Ms Edith Shih and Dr Dan Eldar, being directors of CK Hutchison or its related companies, voluntarily abstained from voting on the board resolutions of the Company approving the renewal of the HBYS Brand License Royalty Agreement.
D. IMPLICATIONS UNDER THE LISTING RULES
(1) Framework Sinopharm Products Supply and Purchase Agreement
As Sinopharm is a substantial shareholder of a subsidiary of the Company, it is a connected person of the Company and the supply to and purchase from Sinopharm of products by the Group constitute continuing connected transactions of the Company under Chapter 14A of the Listing Rules.
In relation to each of (i) the supply of products by the Group and (ii) the purchase of products by the Group, the highest applicable percentage ratio in respect of each of the Annual Cap Amounts exceeds 5%. As the transactions are between the Group and a connected person at the subsidiary level and are on normal commercial terms, the Directors have approved the transactions and the independent non-executive Directors have given the confirmation required under Rule 14A.101 of the Listing Rules as set out in paragraph C(3) above, (i) the supply of products by the Group and (ii) the purchase of products by the Group under the Framework Sinopharm Products Supply and Purchase Agreement are subject to the reporting, announcement and annual review requirements, but are exempt from the circular, independent financial advice and independent shareholders’ approval requirements under Chapter 14A of the Listing Rules.
(2) HBYS Brand License Royalty Agreement
As HWEL is a subsidiary of CK Hutchison, it is a connected person of the Company by virtue of being an associate of a substantial shareholder of the Company and the license granted under the HBYS Brand License Royalty Agreement constitute continuing connected transactions of the Company under Chapter 14A of the Listing Rules.
As the highest applicable percentage ratio in respect of the annual fee payable by HCMH under the HBYS Brand License Royalty Agreement, on an annual basis, exceeds 0.1% but is less than 5%, the transactions contemplated under the HBYS Brand License Royalty Agreement are subject to the reporting, announcement and annual review requirements, but are exempt from the circular, independent financial advice and independent shareholders’ approval requirements under Chapter 14A of the Listing Rules.
E. INFORMATION ON THE PARTIES
(1) The Company
The Company is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the centre of which is a team of about 1,800 in oncology/immunology. Since inception, it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S..
(2) Sinopharm
Sinopharm and its subsidiaries are mainly principally engaged in the distribution of pharmaceutical products to hospitals, other distributors, retail pharmacy stores and clinics, the distribution of medical devices, the operation of chain pharmacy stores, and the distribution of laboratory supplies, manufacture and distribution of chemical reagents, and production and sale of pharmaceutical products. The ultimate controlling shareholder of Sinopharm is China National Pharmaceutical Group Co., Ltd., a state-owned enterprise established in the PRC.
(3) HWEL
HWEL is an indirect wholly-owned subsidiary of CK Hutchison and is principally engaged in the holding of the trademarks of CK Hutchison group.
F. DEFINITIONS
In this announcement, unless the context otherwise requires, the following expressions have the following meanings:
| “Annual Cap Amounts” | the annual cap amounts for the Continuing Connected Transactions for the three financial years ending December 31, 2024, 2025 and 2026 |
| “CK Hutchison” | CK Hutchison Holdings Limited, a company incorporated in the Cayman Islands with limited liability, the shares of which are listed on the Main Board of the Stock Exchange (stock code: 1) |
| “Company” or “HUTCHMED” | HUTCHMED (China) Limited, a company incorporated in the Cayman Islands with limited liability, the shares of which are listed on the Main Board of the Stock Exchange (stock code: 13), the AIM market of the London Stock Exchange (stock code: HCM) and in the form of American depositary shares on the NASDAQ Global Select Market (ticker symbol: HCM) |
| “Continuing Connected Transactions” | the transactions contemplated under the Framework Sinopharm Products Supply and Purchase Agreement and the HBYS Brand License Royalty Agreement |
| “Directors” | the directors of the Company |
| “Framework Sinopharm Products Supply and Purchase Agreement” | the framework products supply and purchase agreement dated June 15, 2021 entered into between the Company and Sinopharm in relation to (i) supply of products by the Group to Sinopharm and/or its associates and (ii) purchase of products by the Group from Sinopharm and/or its associates |
| “FY” | financial year ending or ended December 31 |
| “Group” | the Company and its subsidiaries |
| “HBYS Brand License Royalty Agreement” | the brand license royalty agreement dated and as amended and restated with effect from June 15, 2021 entered into between HCMH and HWEL in relation to the payment of annual fee by HCMH to HWEL in consideration of the grant of the royalty-free right to use the HWL Trade Marks by HWEL to Hutchison Baiyunshan and its subsidiary undertakings |
| “HBYS Disposal” | the disposal by HBYSGH of the entire issued share capital of HCMGIL pursuant to the HBYS SPA |
| “HBYS SPA” | the sale and purchase agreement dated March 24, 2021 entered into between HBYSGH and GL Mountrose Investment Two Limited in relation to the sale and purchase of the entire issued share capital of HCMGIL |
| “HBYSGH” | Hutchison BYS (Guangzhou) Holding Limited, a company incorporated in the British Virgin Islands with limited liability and a 80% owned subsidiary of the Company |
| “HCMGIL” | Hutchison Chinese Medicine (Guangzhou) Investment Limited (currently known as GL Mountrose Chinese Medicine (Guangzhou) Investment Limited), a company incorporated in the British Virgin Islands with limited liability and a former indirect 80% owned subsidiary of the Company |
| “HCMH” | Hutchison Chinese Medicine Holding Limited, a company incorporated in the British Virgin Islands with limited liability and a wholly-owned subsidiary of the Company |
| “HK$” | Hong Kong dollar, the lawful currency of Hong Kong |
| “Hong Kong” | the Hong Kong Special Administrative Region of the People’s Republic of China |
| “Hutchison Baiyunshan” | Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited, a company incorporated in the PRC |
| “Hutchison Sinopharm” | Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Company Limited, a company incorporated in the PRC and a subsidiary of the Company |
| “HWEL” | Hutchison Whampoa Enterprises Limited, a company incorporated in the British Virgin Islands and a subsidiary of CK Hutchison |
| “HWL Trade Marks” | certain “Hutchison Whampoa”-related trade marks and logos |
| “Listing Rules” | the Rules Governing the Listing of Securities on the Stock Exchange (as amended and supplemented from time to time) |
| “PRC” or “China” | the People’s Republic of China, but for the purposes of this announcement only, except where the context requires, references to PRC or China exclude Hong Kong, Macau and Taiwan |
| “Shareholder(s)” | the holders of the shares of the Company |
| “Sinopharm” | Sinopharm Group Co. Ltd., a company incorporated in the PRC with limited liability, the shares of which are listed on the Main Board of the Stock Exchange (stock code: 1099) |
| “Stock Exchange” | The Stock Exchange of Hong Kong Limited |
| “US$” | US dollars, the lawful currency of the United States of America |
| “%” | per cent. |
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S.. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
Forward-Looking Statements
This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, the impact of the COVID-19 on general economic, regulatory and political conditions. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.
CONTACTS
| Investor Enquiries | +852 2121 8200 / +1 973 306 4490 / ir@hutch-med.com |
| Media Enquiries | |
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
| Nominated Advisor | |
| Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon | +44 (20) 7886 2500 |
Hong Kong, Shanghai & Florham Park, NJ — Wednesday, December 13, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM, HKEX:13) today announces that under the 2023 simple renewal mechanism of the China National Healthcare Security Administration (“NHSA”), on January 1, 2024 the updated National Reimbursement Drug List (“NRDL”) will continue to include ELUNATE® (fruquintinib) and SULANDA® (surufatinib) at the same terms as the current two-year agreement.
Mr Hong Chen, Senior Vice President and Chief Commercial Officer (China) of HUTCHMED, said: “The NRDL has made it possible for our innovative medicines to quickly reach more patients in need across China. In the past few years, we have seen an array of new measures adopted by the NHSA, including the NRDL negotiation, the bidding process for non-exclusive medicines and simplified renewal rules for already listed medicines. Those new measures provided a solid foundation for the sustainable development of the innovative pharmaceutical industry and continuous improvement of patients’ access to innovative medicines, allowing patients to truly benefit from healthcare innovations.”
ELUNATE® was first included in the NRDL on January 1, 2020, for the treatment of metastatic colorectal cancer (“CRC”). CRC was the third most diagnosed form of cancer by incidence in China in 2020, with an estimated 555,000 new cases each year.[i]
SULANDA® was first included in the NRDL on January 1, 2022, for the treatment of non-pancreatic and pancreatic neuroendocrine tumors (“NETs”). In China, there were an estimated 71,300 newly diagnosed NET patients in 2020, with potentially up to 300,000 patients living with the disease.[ii]
The government in China has placed great importance on improving the affordability of drug treatments for the public. As of 2022, 1.35 billion people in China had basic medical insurance coverage, representing around 95% of the entire population. The NRDL is updated every year, and inclusion on the list is subject to renewal every two years. The NHSA annually convenes a broad network of experts in medicine, pharmacology, pharmacoeconomics and actuarial valuation to identify innovative medicines to consider for NRDL inclusion. Reimbursement of Category B medicines, including novel oncology medicines, requires varying degrees of copayment from patients, depending on their province or type of NHSA insurance scheme enrollment.
Fruquintinib is a selective oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”)-1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for the potential use as part of combination therapy. Fruquintinib has demonstrated a manageable safety profile and is being investigated in combinations with other anti-cancer therapies.
Fruquintinib is marketed in China by HUTCHMED under the brand name ELUNATE® following its approval in September 2018, in partnership with Eli Lilly and Company. Fruquintinib is marketed in the United States by its partner Takeda under the brand name FRUZAQLA™, following its approval in November 2023.
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFR and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects. It is marketed in China by HUTCHMED under the brand name SULANDA®.
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations for the commercialization of fruquintinib and surufatinib in China, the potential benefits and further clinical development of fruquintinib and surufatinib, its expectations as to whether further studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the commercial acceptance of fruquintinib and surufatinib, the impact of the inclusion of fruquintinib and surufatinib on the NRDL on sales of the drug and its pricing, clinical trial enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of fruquintinib and surufatinib to obtain regulatory approval for a targeted indication in different jurisdictions and the sufficiency of funding. In addition, as certain studies rely on the use of osimertinib or durvalumab as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval and the impact of COVID-19 on general economic, regulatory and political conditions. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
References
[i] The Global Cancer Observatory. Accessed November 23, 2023.
[ii] According to Frost & Sullivan. Report on file.
| Investor Enquiries | +852 2121 8200 / +1 973 306 4490 / ir@hutch-med.com |
| Media Enquiries | |
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
| Nominated Advisor | |
| Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon | +44 (20) 7886 2500 |
Hong Kong, Shanghai & Florham Park, NJ — Wednesday, December 13, 2023: HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”) today announces that it has completed enrollment of its Phase II/III trial of fruquintinib in combination with sintilimab as second-line treatment for locally advanced or metastatic renal cell carcinoma (“RCC”) in China.
The study is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced RCC. The primary endpoint is progression free survival (“PFS”) per RECIST 1.1 as assessed by blinded independent central review (BICR). The secondary endpoints include objective response rate (“ORR”), disease control rate (“DCR”), duration of response (“DoR”), time to response (TTR), overall survival (“OS”), safety, and quality of life. A total of 234 patients have been enrolled in the study. The leading principal investigators are Dr Dingwei Ye of Fudan University Shanghai Cancer Center and Dr Zhisong He of Peking University First Hospital. Additional details may be found at clinicaltrials.gov, using identifier NCT05522231.
The first patient in China received the first dose on October 27, 2022 and HUTCHMED expects to announce topline results from the study around year end 2024. If favorable, the results would enable a New Drug Application submission to China’s National Medical Products Administration (“NMPA”).
It is estimated that approximately 430,000 new patients were diagnosed with kidney cancer worldwide in 2020.[i] In China, an estimated 74,000 new patients were diagnosed with kidney cancer in 2020.[ii] Approximately 90% of kidney tumors are RCC.
The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated:
Fruquintinib is a selective oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for the potential use as part of combination therapy. Fruquintinib has demonstrated a manageable safety profile and is being investigated in combination with other anti-cancer therapies including the approved PD-1 inhibitor, sintilimab.
The U.S. Food and Drug Administration (“FDA”) has approved five immune-oncology combination therapies for first-line treatment of advanced RCC, however, no immune-oncology combination therapies have been approved in China, indicating an unmet medical need in these settings.
As presented at the 2023 American Society of Clinical Oncology Annual Meeting (ASCO), a proof of concept study of fruquintinib plus sintilimab demonstrated promising efficacy and tolerable safety profile in this setting. At the data cutoff date of November 30, 2022, all 20 enrolled previously treated patients were efficacy evaluable, and median follow-up duration was 23.3 months. The confirmed ORR was 60.0% and DCR was 85.0%. Median DoR was 13.9 months and mPFS was 15.9 months. OS was not reached.
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the submission of a NDA for fruquintinib for the treatment of RCC with the NMPA and the timing of such submission, the therapeutic potential of fruquintinib for the treatment of patients with RCC and the further clinical development of fruquintinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support NDA approval of fruquintinib for the treatment of patients with CRC, RCC or other indications in China or other jurisdictions, its potential to gain approvals from regulatory authorities on an expedited basis or at all; the efficacy and safety profile of fruquintinib; HUTCHMED ability to fund, implement and complete its further clinical development and commercialization plans for fruquintinib; the timing of these events; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or the regulatory pathway for fruquintinib; and the impact of COVID-19 on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of other drug products such as sintilimab as combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Such forward-looking statements include, without limitation, statements regarding the plan to develop, manufacture and commercialize fruquintinib; and HUTCHMED’s strategy, goals and anticipated milestones, business plans and focus. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and on The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
[i] The Global Cancer Observatory, kidney cancer fact sheet. https://gco.iarc.fr/today/data/factsheets/cancers/29-Kidney-fact-sheet.pdf. Accessed September 28, 2022.
[ii] The Global Cancer Observatory, China fact sheet. https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf. Accessed September 30, 2022.
On December 7, 2023, the Seller (a wholly-owned subsidiary of the Company) and HWCL (an indirect subsidiary of CK Hutchison) entered into the Share Sale and Purchase Agreement relating to the disposal by the Seller of its interest in the Consumer Products Businesses for an aggregate purchase price of HK$39.8 million (US$5.1 million).
Closing of the Disposal took place on the date of the Share Sale and Purchase Agreement.
REASONS FOR, AND BENEFITS OF, THE DISPOSAL
As the core business of the Group is the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases, the disposal by the Seller of its interest in the Consumer Products Businesses will allow the Group to focus resources on its core business areas.
IMPLICATIONS UNDER THE LISTING RULES
As at the date of this announcement, Hutchison Healthcare Holdings Limited holds approximately 38.16% of the shares in the Company. As HWCL is the holding company of Hutchison Healthcare Holdings Limited, HWCL is a connected person of the Company, and the Disposal constitutes a connected transaction of the Company under Chapter 14A of the Listing Rules.
As one of the applicable percentage ratios (namely, the profits ratio) in respect of the Disposal exceeds 5% but all are less than 25%, the Disposal constitutes a discloseable transaction for the Company under Chapter 14 of the Listing Rules. As one or more of the applicable percentage ratios in respect of the Disposal exceed 0.1% but all (other than the profits ratio) are less than 5%, the Disposal is subject to the reporting and announcement requirements but is exempt from the circular and independent shareholders’ approval requirements under Chapter 14A of the Listing Rules.
CONTACTS
| Investor Enquiries | +852 2121 8200 / +1 973 306 4490 / ir@hutch-med.com |
| Media Enquiries | |
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
| Nominated Advisor | |
| Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon | +44 (20) 7886 2500 |
Hong Kong, Shanghai & Florham Park, NJ — Friday, December 1, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today highlights that new clinical data from several ongoing studies with HUTCHMED investigational drug candidates fruquintinib, surufatinib and HMPL-295, which will be presented at the upcoming European Society for Medical Oncology (“ESMO”) Asia Congress, taking place on December 1-3, 2023 in Singapore, and the ESMO Immuno-Oncology Congress, taking place on December 6‑8, 2023 in Geneva, Switzerland.
HMPL-295:
| Title: | A first in human, open-label, dose-escalation study of ERK1/2 inhibitor HMPL-295 in patients with advanced solid tumors |
| Lead Author: | Rujiao Liu, Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China |
| Type: | Oral presentation |
| Abstract # & Link: | 77MO |
| Session & Location: | ESMO Asia – Developmental and precision medicine (ID 29), Hall 402 |
| Date & Time: | Friday, December 1, 2023, 11:50 am Singapore time |
This presentation will report data from a multi-center, open-label clinical trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy profile of HMPL-295, and to determine the maximum tolerated dose (“MTD”) and recommended Phase II dose in patients with advanced malignant solid tumors. The continuous-administration MTD was determined to be 50 mg QD, and intermittent administration studies are ongoing.
HMPL-295 is an investigational, selective, oral inhibitor of extracellular signal-regulated kinase 1 & 2 (ERK1/2), which is a downstream component of the RAS-MAPK pathway signaling cascade. The investigational compound has the potential to address intrinsic or acquired resistance from upstream mechanisms such as RAS, RAF and MEK. HMPL-295 is one of several investigational compounds discovered by HUTCHMED that target the RAS-MAPK pathway.
Fruquintinib:
| Title: | Fruquintinib plus sintilimab in advanced cervical cancer patients: Results from a multicenter, single-arm Phase II study |
| Lead Author: | Xiaotian Han, Oncologic Gynecology Department, Fudan University Shanghai Cancer Center, Shanghai, China |
| Type: | Oral presentation |
| Abstract # & Link: | 289MO |
| Session & Location: | ESMO Asia – Gynaecological cancers (ID 28), Hall 401 |
| Date & Time: | Friday, December 1, 2023, 11:25 am Singapore time |
| Title: | Fruquintinib plus sintilimab in patients with advanced non-small cell lung cancer (“NSCLC”) with PD-L1 positive expression: A multicenter, single-arm phase II study |
| Lead Author: | Shun Lu, Shanghai Lung Cancer Center, Shanghai Chest Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China |
| Abstract # & Link: | 496P |
| Session & Location: | ESMO Asia – Poster Display (ID78), Exhibition area |
| Date & Time: | Saturday, December 2, 2023, 5:50 pm Singapore time |
These presentations will report results from the cervical cancer and NSCLC patient cohorts of the basket clinical trial in China of fruquintinib plus sintilimab. This trial is an open-label, multi-center, non-randomized, Phase ІІ study to assess the safety and efficacy of fruquintinib in combination with sintilimab in patients with advanced cervical cancer, endometrial cancer (“EMC”), gastric cancer (GC), hepatocellular carcinoma (HCC), NSCLC or renal cell carcinoma (“RCC”). Data from the EMC and RCC cohorts of this trial led to the initiation of registration enabling programs. This combination treatment showed promising antitumor activity in advanced cervical cancer and NSCLC patients, particularly for patients with PD-L1 positive status. This combination treatment also showed manageable toxicity profiles consistent with that seen in other cohorts.
Fruquintinib is a selective oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for the potential use as part of combination therapy. Fruquintinib has demonstrated a manageable safety profile and is being investigated in combination with other anti-cancer therapies including the approved PD-1 inhibitor, sintilimab.
| Title: | Efficacy and safety of fruquintinib + best supportive care (BSC) vs placebo + BSC in refractory metastatic colorectal cancer: Asian vs non-Asian outcomes in FRESCO-2 |
| Lead Author: | Daisuke Kotani, National Cancer Center Hospital East Kashiwa, Japan |
| Abstract # & Link: | 93P |
| Session & Location: | ESMO Asia – Poster Display (ID78), Exhibition area |
| Date & Time: | Saturday, December 2, 2023, 5:50 pm Singapore time |
This presentation will report efficacy and safety data according to race for Asian and non-Asian patient subgroups from the FRESCO-2 study. FRESCO-2 is a global Phase III multi-regional clinical trial (MRCT) conducted in the U.S., Europe, Japan and Australia investigating fruquintinib plus best supportive care (“BSC”) vs. placebo plus BSC in patients with previously treated metastatic colorectal cancer. There was a clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) in both Asian and non-Asian patients. The safety and efficacy subgroup analysis results were consistent with the overall FRESCO-2 population and with the established monotherapy profile of fruquintinib.
Investigator-initiated studies presentations:
| Abstract title | Presenter / Lead author | Presentation details |
| ESMO Asia Congress 2023 | ||
| Tyrosine kinase Inhibitor (TKI) plus PD-1 blockade in TKI-responsive MSS/pMMR metastatic colorectal adenocarcinoma: updated results of TRAP study | Jingdong Zhang, Qian Dong,Medical Oncology Department of Gastrointestinal Cancer, Liaoning Cancer Hospital & Institute, Shenyang, China | 96P Poster presentation (Gastrointestinal tumours, colorectal) Saturday, December 2, 2023 |
| Efficacy and safety of fruquintinib with Nab-Paclitaxel in Advanced G/GEJ cancer after exposure to immune checkpoint inhibitors: A single-center prospective clinical trial | Lin Yang, Xiaoting Ma, Department of Medical Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College – National Cancer Center, Beijing, China |
186P Poster presentation (Gastrointestinal tumours, non-colorectal) Saturday, December 2, 2023 |
| ESMO Immuno-Oncology Congress 2023 | ||
| A single-center, Phase II study of surufatinib combined with toripalimab, pemetrexed, and platinum in patients with advanced non-squamous non-small cell lung cancer (nsq-NSCLC) | Li Zhang, Wenfeng Fang, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China |
74P Poster Display Thursday, December 7, 2023 |
| Surufatinib plus toripalimab combined with etoposide and cisplatin in patients with advanced naïve small cell lung cancer (SCLC) – Updated results of a phase Ib/II trial | Li Zhang, Wenfeng Fang, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China |
124P Poster Display Thursday, December 7, 2023 |
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, surufatinib and HMPL-295, the further clinical development for fruquintinib, surufatinib and HMPL-295, its expectations as to whether any studies on fruquintinib, surufatinib and HMPL-295 would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support approval of fruquintinib, surufatinib and HMPL-295 for the treatment of patients with colorectal cancer or other indications in jurisdictions such as China, the U.S., the E.U. or Japan, its potential to gain approvals from regulatory authorities on an expedited basis or at all; the efficacy and safety profile of fruquintinib, surufatinib and HMPL-295; assumptions regarding changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, surufatinib and HMPL-295, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, surufatinib and HMPL-295 for a targeted indication; the sufficiency of funding; and the impact of COVID-19 or other infectious diseases on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of nab-paclitaxel, sintilimab, toripalimab, pemetrexed, platinum, etoposide or cisplatin as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
CONTACTS
| Investor Enquiries | +852 2121 8200 / +1 973 306 4490 / ir@hutch-med.com |
| Media Enquiries | |
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
| Nominated Advisor | |
| Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon | +44 (20) 7886 2500 |