Nasdaq:US$16.50 (+0.14) | HKEX:HK$26.00 (-0.10) | AIM:£2.70 (-0.01)
News & Presentations
  • Hutchmed
  • |  Announcements & Press Releases

London: Thursday, December 31, 2020: Hutchison China MediTech Limited (“Chi-Med” or the “Company”) (AIM/Nasdaq: HCM) announces the following blocklisting six monthly return:

 

1. Name of applicant: Hutchison China MediTech Limited
2. Name of scheme: (a) Share Option Scheme conditionally adopted by Hutchison China MediTech Limited in 2005 (“2005 HCML Share Option Scheme”)
(b) Share Option Scheme conditionally adopted by Hutchison China MediTech Limited in 2015 (“2015 HCML Share Option Scheme”)
(c) Warrant instrument granted by Hutchison China MediTech Limited on June 25, 2020 (“Warrant”)
3. Period of return: From June 29, 2020 to December 28, 2020
4.

Balance under scheme from previous return:

 

(a) 2005 HCML Share Option Scheme: 1,738,910 ordinary shares of US$0.1 each
(b) 2015 HCML Share Option Scheme: 23,130,970 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 HCML Share Option Scheme: Nil
(b) 2015 HCML Share Option Scheme: 30,221,458 ordinary shares of US$0.1 each
(c) Warrant: 16,666,670 ordinary shares of US$0.1 each
6.

Number of securities issued/allotted under scheme during period:

 

(a) 2005 HCML Share Option Scheme: 400,000 ordinary shares of US$0.1 each
(b) 2015 HCML Share Option Scheme: 80,780 ordinary shares of US$0.1 each
(c) Warrant: nil
7.

Balance under scheme not yet issued/allotted at end of the period:

 

(a) 2005 HCML Share Option Scheme: 1,338,910 ordinary shares of US$0.1 each
(b) 2015 HCML Share Option Scheme: 53,271,648 ordinary shares of US$0.1 each
(c) Warrant: 16,666,670 ordinary shares of US$0.1 each
8.

Number and class of securities originally listed and the date of admission:

 

(a) 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)
(b) 16,666,670 ordinary shares of US$0.1 each admitted on July 6, 2020
9. Total number of securities in issue at the end of the period: 727,722,215 ordinary shares of US$0.1 each
Name of contact: Christian Hogg
Address of contact: Level 18, The Metropolis Tower, 10 Metropolis Drive, Hung Hom, Kowloon, Hong Kong
Telephone number of contact: +852 2121 8200

 

 

About Chi-Med

Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of nine cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.

 

CONTACTS

Investor Enquiries

Mark Lee, Senior Vice President
+852 2121 8200

Annie Cheng, Vice President
+1 (973) 567 3786

 

Media Enquiries

Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com

UK & Europe –Ben Atwell / Alex Shaw, FTI Consulting
+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
Chi-Med@fticonsulting.com

Asia – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com

Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com


Nominated Advisor

Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500

London: Thursday, December 31, 2020: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) hereby notifies the market that as at December 31, 2020, the issued share capital of Chi-Med consisted of 727,722,215 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 727,722,215 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, Chi-Med under the Financial Conduct Authority’s Disclosure Rules and Transparency Rules.

For illustrative purposes only, the 727,722,215 ordinary shares would be equivalent to 727,722,215 CREST depositary interests (each equating to one ordinary share) which are traded on AIM or, if the CREST depositary interests were converted in their entirety, equivalent to 145,544,443 American depositary shares (each equating to five ordinary shares) which are traded on Nasdaq.

 

About Chi-Med

Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases.  It has a portfolio of nine cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com

 

CONTACTS

Investor Enquiries

Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786

Media Enquiries

Americas
Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Europe
Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia
Joseph Chi Lo, Brunswick +852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Zhou Yi, Brunswick +852 9783 6894 (Mobile)
yzhou@brunswickgroup.com

Nominated Advisor

Freddy Crossley / Atholl Tweedie,
Panmure Gordon (UK) Limited
+44 (20) 7886 2500

 

– Sulanda® is Chi-Med’s first oncology drug brought to market without a partnership and the company’s second oncology drug approved in China –

– The pivotal Phase III SANET-ep trial demonstrated surufatinib reduced risk of progression or death by 67%, extending PFS in all subgroups of non-pancreatic NET patients with an acceptable risk/benefit ratio –

– ~400-strong oncology commercial team in place to bring Sulanda® to patients in China –

 

Hong Kong, Shanghai, & Florham Park, NJ: Wednesday, December 30, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that surufatinib has been granted approval for drug registration by the National Medical Products Administration of China (“NMPA”) for the treatment of non-pancreatic neuroendocrine tumors (“NETs”). Surufatinib will be marketed in China under the brand name Sulanda®. Surufatinib is Chi-Med’s first self-discovered oncology drug to be approved in China without the support of a development partner, and follows the approval of Chi-Med’s first oncology drug, Elunate® (fruquintinib capsules), in 2018.

Christian Hogg, Chief Executive Officer of Chi-Med commented, “We are very pleased to have achieved this major milestone for Chi-Med. The approval of surufatinib, our first un-partnered oncology drug, is a strong testament to our in-house research and development capability.”

“Today’s approval also marks an important development for NET patients, for whom there are currently limited treatment options. Compared with other NET therapies available in the market, surufatinib has a unique mode of action by both inhibiting angiogenesis and promoting the body’s immune response against tumor cells. If our second new drug application (“NDA”) in pancreatic NET is successful, this therapy would be approved in China to address all NET patients regardless of the tumor origin.”

“We look forward to making this unique therapy available to patients as quickly and broadly as possible through our own expanded oncology commercial team.”

Chi-Med has established an oncology commercial team that today covers more than 2,000 hospitals across China. The team is led by a leadership team highly experienced in oncology products commercialization in China with deep knowhow in the field of NETs.

The NMPA approval of Sulanda® was based on results from the SANET-ep[1] study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced non-pancreatic NETs conducted in China. The study met the pre-defined primary endpoint of progression-free survival (“PFS”) at a preplanned interim analysis. The positive results of this trial were highlighted in an oral presentation at the 2019 ESMO Congress and published in The Lancet Oncology in September 2020.[2] Median PFS was significantly longer for patients treated with surufatinib at 9.2 months, compared to 3.8 months for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib had an acceptable safety profile, with the most common treatment-related adverse events of grade 3 or worse being hypertension (36% of surufatinib patients vs. 13% of placebo patients), proteinuria (19% vs. 0%) and anemia (5% vs. 3%).

In China, there were an estimated 67,600 newly diagnosed NET patients in 2018. Considering the current incidence to prevalence ratio, there may be as many as 300,000 patients living with the disease.[3]

 

About NETs

NETs form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. NETs are typically classified as pancreatic NET (“pNET”) or non-pancreatic NET (“epNET”). Approved targeted therapies include Sutent® (for pNET only) and Afinitor® for pNET and well-differentiated, non-functional gastrointestinal or lung NET.

According to Frost and Sullivan, there were 19,000 newly diagnosed cases of NETs in the U.S. in 2018. Importantly, NETs are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 141,000 estimated patients living with NETs in the U.S. in 2018.

 

About Surufatinib (Sulanda® in China)

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (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.

Chi-Med currently retains all rights to surufatinib worldwide.

 

About Surufatinib Development

NETs in the U.S. and Europe: In the U.S., surufatinib was granted Fast Track Designations for development in pNET and epNET in April 2020, and Orphan Drug Designation for pNET in November 2019. A U.S. FDA NDA rolling submission was initiated in December 2020, to be followed by a marketing authorization application (MAA) submission to the European Medicines Agency (EMA) in Europe. The basis to support these filings includes the completed SANET-ep and SANET-p[4] studies, along with existing data from surufatinib in U.S. non-pancreatic and pancreatic NET patients (clinicaltrials.gov identifier: NCT02549937).

Pancreatic NETs in China: The SANET-p study is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pNET in China. It was terminated early as the pre-defined primary endpoint of PFS was met (clinicaltrials.gov identifier: NCT02589821) at an preplanned interim analysis, leading to a second NDA accepted by the China NMPA in September 2020. The results of this study were presented at the ESMO Virtual Congress 2020 and published simultaneously in The Lancet Oncology. [5]

Biliary tract cancer in China: A Phase IIb/III study was initiated in March 2019, comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier NCT03873532).

Immunotherapy combinations: Chi-Med has entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317, developed by BeiGene, Ltd.), Tuoyi® (toripalimab, developed by Shanghai Junshi Biosciences Co. Ltd.) and Tyvyt® (sintilimab, developed by Innovent Biologics, Inc.), which are approved as monotherapies in China.

 

About Chi-Med

Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of nine cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.

 

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 Chi-Med’s current expectations regarding future events, including its expectations regarding the commercial launch of surufatinib in China, the ability of its in-house oncology sales team to distribute surufatinib quickly and broadly, the potential market for surufatinib in non-pancreatic NET patients China, the potential approval of surufatinib in pancreatic NET, and the further clinical development for surufatinib in these and other indications in China, the United States and other jurisdictions. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding Chi-Med’s ability to commercialize surufatinib, the benefits obtained from surufatinib during clinical trials being the same for all patients who are prescribed surufatinib, no unidentified side effects occurring which could result in the NMPA pulling surufatinib from the market, Chi-Med’s ability to fund, implement and complete its further clinical development and commercialization plans for surufatinib, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of capecitabine, tislelizumab, Tuoyi®, and Tyvyt® as combination therapeutics with surufatinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. 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 Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med 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.

 

Inside Information

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.

 

[1] Surufatinib in advanced neuroendocrine tumors – extra-pancreatic (non-pancreatic).
[2] Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30496-4. DOI: 10.1016/S1470-2045(20)30496-4.
[3] According to Frost & Sullivan. In 2018, there were 19,000 newly diagnosed cases of NETs in the U.S and an estimated 141,000 patients living with NETs. The current incidence to prevalence ratio in China is estimated at 4.4, lower than the 7.4 ratio in the U.S. due to lower access to treatment options.
[4] Surufatinib in advanced neuroendocrine tumors – pancreatic.
[5] Xu J, Shen L, Bai C, et al. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30493-9. DOI: 10.1016/S1470-2045(20)30493-9.

 

CONTACTS

Investor Enquiries

Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786

Media Enquiries

Americas
Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Europe
Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia
Joseph Chi Lo, Brunswick +852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Zhou Yi, Brunswick +852 9783 6894 (Mobile)
yzhou@brunswickgroup.com

Nominated Advisor

Freddy Crossley / Atholl Tweedie,
Panmure Gordon (UK) Limited
+44 (20) 7886 2500

 

– Company plans to complete rolling submission in the first half of 2021 –

– The pivotal Phase III SANET-ep trial demonstrated surufatinib reduced risk of progression or death by 67%, extending PFS of non-pancreatic NET patients with an acceptable risk/benefit ratio –

– The pivotal Phase III SANET-p trial demonstrated surufatinib reduced risk of progression or death by 51%, extending PFS of pancreatic NET patients with an acceptable risk/benefit ratio –

– First NDA submission by Chi-Med in the United States –

 

Hong Kong, Shanghai, & Florham Park, NJ: Monday, December 28, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that it has initiated the filing of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) – the first portion of a rolling submission for surufatinib for the treatment of pancreatic and non-pancreatic neuroendocrine tumors (“NET”). Chi-Med plans to complete the NDA submission in the first half of 2021, which would be the company’s first NDA in the U.S.

The Fast Track Designation granted earlier this year by the FDA permits the company to submit sections of the NDA on a rolling basis. The NDA is supported by data from the two positive Phase III studies of surufatinib in NET in China, along with data from surufatinib studies in U.S. non-pancreatic and pancreatic NET patients. The company previously announced that it had reached an agreement with the FDA during a pre-NDA meeting, whereby these studies may serve as the basis to support an NDA submission. Filing acceptance of the NDA is subject to FDA review of the complete application. The data package will also be used to file a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) in 2021, based on scientific advice from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Marek Kania, M.D., Managing Director and Chief Medical Officer of Hutchison MediPharma International, said, “With the initiation of our first regulatory filing in the U.S., we are executing our strategy of building a global pharmaceutical company that brings innovative cancer therapies to patients worldwide. There is a great need for additional therapies to treat neuroendocrine tumors, and surufatinib has demonstrated significant clinical benefit in patients with advanced tumors. The NDA filing to the U.S. FDA represents a significant step toward our goal of commercializing surufatinib and other novel therapies globally.”

The company plans to initiate an Expanded Access Protocol to ensure patients with limited therapeutic options have access to this important treatment. Enrollment into this early access program is anticipated to begin in the first quarter of 2021, once regulatory clearance of the protocol has been granted by the FDA.

The FDA granted two Fast Track Designations to surufatinib for development in pancreatic and non-pancreatic (extra-pancreatic) NET in April 2020 and Orphan Drug Designation for pancreatic NET in November 2019.

 

About NET

NET form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. NET are typically classified as pancreatic NET or non-pancreatic NET. Approved targeted therapies include Sutent® and Afinitor® for pancreatic NET, or well-differentiated, non-functional gastrointestinal or lung NET.

According to Frost and Sullivan, there were 19,000 newly diagnosed cases of NET in the U.S. in 2018. Importantly, NET are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 141,000 estimated patients living with NET in the U.S. in 2018.[1]

 

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (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.

Chi-Med currently retains all rights to surufatinib worldwide.

 

About Surufatinib Development

NET in the U.S., Europe and Japan: In the U.S., surufatinib was granted Fast Track Designations for development in pancreatic and non-pancreatic (extra-pancreatic) NET in April 2020 and Orphan Drug Designation for pancreatic NET in November 2019. A U.S. FDA NDA submission was initiated in December 2020, to be followed by a MAA submission to the EMA in Europe. The basis to support these filings includes the completed SANET-ep and SANET-p[2] studies, along with existing data from surufatinib in U.S. non-pancreatic and pancreatic NET patients (clinicaltrials.gov identifier: NCT02549937).

Non-pancreatic NET in China: In November 2019, a NDA for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by the National Medical Products Administration of China (“NMPA”) and granted Priority Review status in December 2019. The NDA is supported by data from the successful SANET-ep[3] study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced non-pancreatic NETs conducted in China. The study had met the pre-defined primary endpoint of progression-free survival (“PFS”) at a preplanned interim analysis. The positive results of this trial were highlighted in an oral presentation at the 2019 ESMO Congress and published in The Lancet Oncology in September 2020.[4] SANET-ep demonstrated that surufatinib reduces risk of progression or death by 67%, with median PFS significantly longer for patients treated with surufatinib at 9.2 months, compared to 3.8 months for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib had an acceptable risk/benefit ratio.

Pancreatic NET in China: In 2016, we initiated the SANET-p study, which is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pancreatic NET in China. It was terminated early as the pre-defined primary endpoint of PFS was met (clinicaltrials.gov identifier: NCT02589821) at a preplanned interim analysis, leading to a second NDA accepted by the China NMPA in September 2020. The positive results of this study were presented at the 2020 ESMO Virtual Congress and published simultaneously in The Lancet Oncology[5], demonstrating that surufatinib reduces the risk of disease progression or death by 51% in patients, with median PFS of 10.9 months compared to 3.7 months on placebo (HR 0.491; 95% CI: 0.391-0.755; p=0.0011). The safety profile of surufatinib was manageable and consistent with observations in prior studies.

Biliary tract cancer in China: In March 2019, we initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier: NCT03873532).

Immunotherapy combinations: We have entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317), Tuoyi® (toripalimab) and Tyvyt® (sintilimab), which are approved as monotherapies in China.

 

About Chi-Med

Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of nine cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.

 

Forward-Looking Statements

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 Chi-Med’s current expectations regarding future events, including its expectations regarding the submission of an NDA for surufatinib for the treatment of NET with the FDA and the timing of such submission, the therapeutic potential of surufatinib for the treatment of patients with NET and the further clinical development of surufatinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support NDA approval of surufatinib for the treatment of patients with NET in the U.S., China and other jurisdictions such as the E.U., its potential to gain expeditious approvals from regulatory authorities, the safety profile of surufatinib, Chi-Med’s ability to fund, implement and complete its further clinical development and commercialization plans for surufatinib, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of capecitabine, tislelizumab, Tuoyi®, and Tyvyt® as combination therapeutics with surufatinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. 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 Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med 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.

 

[1] According to Frost & Sullivan, in 2018, there were 19,000 newly diagnosed cases of NETs in the U.S. and an estimated 141,000 patients living with NETs. The current incidence to prevalence ratio in China is estimated at 4.4, lower than the 7.4 ratio in the U.S. due to lower access to treatment options.
[2] Surufatinib in advanced neuroendocrine tumors – pancreatic.
[3] Surufatinib in advanced neuroendocrine tumors – extra-pancreatic.
[4] Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30496-4. DOI: 10.1016/S1470-2045(20)30496-4.
[5] Xu J, Shen L, Bai C, et al. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30493-9. DOI: 10.1016/S1470-2045(20)30493-9.

 

CONTACTS

Investor Enquiries

Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786

Media Enquiries

Americas
Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Europe
Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia
Joseph Chi Lo, Brunswick +852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Zhou Yi, Brunswick +852 9783 6894 (Mobile)
yzhou@brunswickgroup.com

Nominated Advisor

Freddy Crossley / Atholl Tweedie,
Panmure Gordon (UK) Limited
+44 (20) 7886 2500

 

Presentation Date: Monday January 11, 2021
Presentation Time: 8 a.m. EST (1 p.m. GMT / 9 p.m. HKT)

Watch the Webcast Replay

Hong Kong, Shanghai, & Florham Park, NJ: Tuesday, December 22, 2020:  Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that Christian Hogg, Chief Executive Officer, will present at the 39th Annual JP Morgan Healthcare Conference taking place virtually on Monday January 11, 2021 at 8 a.m. EST (1 p.m. GMT / 9 p.m. HKT).

The presentation will be webcast live and can be accessed at www.chi-med.com in the Shareholder Information section under “Events, Circulars & Forms.” Investors interested in listening to the live webcast should log on before the start time to download any software required. A replay of the event will be available shortly thereafter, for 90 days.

 

About Chi-Med

Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases.  It has a portfolio of nine cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.

 

Forward-Looking Statements

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. Forward-looking statements involve risks and uncertainties. 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 Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med 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.

 

CONTACTS

Investor Enquiries

Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786

Media Enquiries

Americas
Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Europe
Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia
Joseph Chi Lo, Brunswick +852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Zhou Yi, Brunswick +852 9783 6894 (Mobile)
yzhou@brunswickgroup.com

Nominated Advisor

Freddy Crossley / Atholl Tweedie,
Panmure Gordon (UK) Limited
+44 (20) 7886 2500

 

London: Tuesday, December 15, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) announces that on December 14, 2020, it granted share options under the Share Option Scheme conditionally adopted by Chi-Med at its Annual General Meeting on April 24, 2015 (the “Share Option Scheme”).  The scheme limit of the Share Option Scheme was refreshed on April 27, 2020.

Chi-Med granted share options under its Share Option Scheme to employees to subscribe for a total of 1,535,580 Ordinary Shares represented by 307,116 American Depositary Shares (“ADSs”) (each equating to five Ordinary Shares) subject to the acceptance of the grantees.  Details of such share options granted prescribed are as follows:

Date of grant : December 14, 2020
Exercise price of share options granted : US$29 per ADS
Number of share options granted : 1,535,580 represented by 307,116 ADSs (five share options shall entitle the holder thereof to subscribe for one ADS)
Closing market price of ADSs on the date of grant : US$29 per ADS
Validity period of the share options : From December 14, 2020 to December 13, 2030

 

Among the share options granted, a total of 58,570 share options represented by 11,714 ADSs were granted to Mr Christian Hogg and Dr Weiguo Su (Executive Directors of the Company), being persons discharging managerial responsibility under the EU Market Abuse Regulation as follows:-

Grantee Number of share options granted
Mr Christian Hogg (Executive Director and Chief Executive Officer) 39,610 Ordinary Shares represented by 7,922 ADSs
Dr Weiguo Su (Executive Vice President and Chief Scientific Officer) 18,960 Ordinary Shares represented by 3,792 ADSs

The notification set out below is provided in accordance with the requirements of the EU Market Abuse Regulation.

 

(a) Mr Christian Hogg 

1 Details of the person discharging managerial responsibilities/person closely associated
a) Name  Mr Christian Hogg
2 Reason for the notification
a) Position/status  Executive Director and Chief Executive Officer
b) Initial notification/Amendment  Initial notification
3 Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a) Name  Hutchison China MediTech Limited
b) LEI  2138006X34YDQ6OBYE79
4 Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a)

Description of the financial instrument, type of instrument

Identification code

Option over American Depositary Share (each equating to five Ordinary Shares of US$0.10)

Option over American Depositary Share with ADS ISIN: US44842L1035

b) Nature of the transaction

Grant of options in respect of 39,610 Ordinary Shares represented by 7,922 ADSs under the Share Option Scheme.

The share options granted are exercisable subject to a vesting schedule of 25% on each of the first, second, third and fourth anniversaries of the effective date of grant.

c) Price(s) and volume(s)
Price(s) Volume(s)
Nil 7,922
d) Aggregated information

Aggregated volume
Price
N/A
e) Date of the transaction  2020-12-14
f) Place of the transaction  Outside a trading venue

 

(b) Dr Weiguo Su

1 Details of the person discharging managerial responsibilities/person closely associated
a) Name  Dr Weiguo Su
2 Reason for the notification
a) Position/status  Executive Director and Chief Scientific Officer
b) Initial notification/Amendment  Initial notification
3 Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a) Name  Hutchison China MediTech Limited
b) LEI  2138006X34YDQ6OBYE79
4 Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a)

Description of the financial instrument, type of instrument

Identification code

Option over American Depositary Share (each equating to five Ordinary Shares of US$0.10)

Option over American Depositary Share with ADS ISIN: US44842L1035

b) Nature of the transaction

Grant of options in respect of 18,960 Ordinary Shares represented by 3,792 ADSs under the Share Option Scheme.

The share options granted are exercisable subject to a vesting schedule of 25% on each of the first, second, third and fourth anniversaries of the effective date of grant.

c) Price(s) and volume(s)
Price(s) Volume(s)
Nil 3,792
d) Aggregated information

Aggregated volume
Price
N/A
e) Date of the transaction  2020-12-14
f) Place of the transaction  Outside a trading venue

 

About Chi-Med

Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases.  It has a portfolio of nine cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.

 

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.  Forward-looking statements involve risks and uncertainties.  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 Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM.  Chi-Med 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

Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786

Media Enquiries

Americas
Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Europe
Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia
Joseph Chi Lo, Brunswick +852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Zhou Yi, Brunswick +852 9783 6894 (Mobile)
yzhou@brunswickgroup.com

Nominated Advisor

Freddy Crossley / Atholl Tweedie,
Panmure Gordon (UK) Limited
+44 (20) 7886 2500

 

Tuesday, December 8, 2020

Shanghai: Chi-Med (Nasdaq/AIM: HCM) today held a ground-breaking ceremony in Zhangjiang Hi-Tech Park, Shanghai, commencing construction of a large-scale manufacturing plant for innovative drugs. Representatives from the Shanghai municipal government, Shanghai Free-Trade Zone, Zhangjiang Management Committee and Zhangjiang Group, as well as partners including Sinopharm Group, AstraZeneca and Eli Lilly, attended the ground-breaking ceremony.

The Shanghai Factory will be Chi-Med’s largest manufacturing facility, with production capacity estimated to be five times that of its manufacturing plant in Suzhou. The current Suzhou site is a GMP-certified production facility, supplying drug candidates for clinical trials and the commercialization of Elunate® (fruquintinib capsules). Chi-Med plans to continue to invest resources in the Suzhou facility, expanding the production team in phases.

Mr. Christian Hogg, Chief Executive Officer of Chi-Med, said, “We are pleased to witness another important milestone for Chi-Med in Zhangjiang, where our innovation started. It is here that our team of scientists has been discovering and developing our innovative therapies. Our self-discovered drug Elunate® (fruquintinib) is available to patients in China and we have two more in-house discovered drug candidates, surufatinib and savolitinib, under review in China, both of which we aim to launch next year. Building on our leading position in China, Chi-Med is striding towards our global ambitions.  We plan to submit the new drug application for surufatinib in the U.S. around the end of the year. The establishment of the Shanghai Factory will significantly increase Chi-Med’s production capacity to bring our home-grown Chinese innovations to more patients in China and around the world.”

The Shanghai Factory site spans 28,700 square meters. Constructed in two phases, the buildings will have a total floorplan of almost 55,000 square meters. The first phase will be primarily for small molecule production, with production capacity expected to be able to produce 250 million tablets and 550 million capsules per year. The second phase is expected to include expansion into large molecule production.

 

A rendering of Chi-Med’s forthcoming large-scale manufacturing plant in Shanghai

 

About Chi-Med

Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases.  It has a portfolio of nine cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.

 

Forward-Looking Statements

This 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 Chi-Med’s current expectations regarding future events and can be identified by words like “will,” “plan,” “aim,” “expect,” “believe” or similar terms, or by express or implied discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events and are subject to significant known and unknown risks and uncertainties. Such risks and uncertainties include, among other things, potential delays in construction, the ability to obtain project financing on acceptable terms or at all, the ability to meet the staffing or production capabilities as planned and the impact of the COVID-19 pandemic on these events as well as 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 Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM.  Chi-Med undertakes no obligation to update or revise the information contained in here, whether as a result of new information, future events or circumstances or otherwise.

 

CONTACTS

Investor Enquiries

Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786

Media Enquiries

Americas
Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Europe
Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia
Joseph Chi Lo, Brunswick +852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Zhou Yi, Brunswick +852 9783 6894 (Mobile)
yzhou@brunswickgroup.com

Nominated Advisor

Freddy Crossley / Atholl Tweedie,
Panmure Gordon (UK) Limited
+44 (20) 7886 2500

 

Title: Results from a Phase 1 Dose Escalation Study of HMPL-689, a Selective Oral Phosphoinositide 3-Kinase-Delta Inhibitor, in Chinese Patients with Relapsed/Refractory (R/R) Lymphoma
Lead Author:
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma - Clinical Studies: Poster I
Abstract # / Link: #1135 / https://doi.org/10.1182/blood-2020-136013
Date & Time: Saturday, December 5, 2020, 7:00 AM - 3:30 PM (PT)

 

Introduction

HMPL-689 is a potent and highly selective small molecule inhibitor of phosphoinositide 3-kinase-delta (PI3Kδ). Despite available agents targeting the B-cell receptor (BCR) pathway, there remains a need for alternative therapies in the relapsed/refractory (R/R) setting due to agent-specific toxicities and suboptimal efficacy among lymphoma subtypes. This study (NCT03128164) is a phase 1, open-label, dose escalation and expansion study in China to assess the safety, pharmacokinetics (PK), and preliminary efficacy of HMPL-689 as a monotherapy in patients with R/R lymphomas. Here we present the preliminary results of the dose-escalation phase of the study.

 

Methods

In this dose escalation phase, patients with R/R lymphoma failed of standard therapy, at least 1 prior therapy, were eligible. The dose-escalation study consisted of cohort A (BID) and cohort B (QD), in which HMPL-689 was orally administered continuously on a 28-day cycle. The modified toxicity probability interval scheme-2 (mTPI-2) design was applied for the dose escalation and maximum tolerated dose (MTD) determination. Blood samples for PK and pharmacodynamics (PD) analyses were collected during Cycle 1 and Day 1 of each subsequent cycle.

 

Results

A total of 56 patients were enrolled, with 5 chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), 23 follicular lymphoma (FL), 7 marginal zone lymphoma (MZL), 9 mantle cell lymphoma (MCL), 9 diffuse large B cell lymphoma (DLBCL), and 3 Hodgkin's lymphoma (HL) patients (Table 1). The median age was 56 years (range 26-73). The median number of prior therapies was 3 (range 1-8), of which 39 patients had prior exposure to rituximab. 29 patients received HMPL-689 in cohort A (BID): 2.5 mg (n=3), 5 mg (n=9), 7.5 mg (n=8), and 10 mg (n=9), while 27 patients were in cohort B (QD): 5 mg (n=3), 10 mg (n=3), 20 mg (n=9), 30 mg (n=9), and 40 mg (n=3). Median duration of HMPL-689 therapy was 7.6 months (range 0.4 -Not reached [NR]).

The most common Grade ≥3 non-hematologic treatment emergent adverse events (TEAEs) were pneumonia and hypertension. Grade ≥3 hematologic TEAEs were neutropenia (Table 2). No Grade 5 TEAE was reported. In cohort A, 4 dose limited toxicities (DLTs) were observed, including Grade 3 asymptomatic amylase (2 pts, 5 mg), Grade 4 hypercalcemia (1 pt, 10 mg), Grade 3 lipase increased (1 pt, 10 mg). In cohort B, 5 DLTs including Grade 3 skin maculopapular (1 pt, 20 mg), hypertriglyceridemia (1 pt, 30 mg), QT interval prolongation (1 pt, 30 mg) and rash (2 pts, 40 mg) were reported. Plasma PK data for the 5-30 mg QD and 2.5-10 mg BID multiple-dose regimens were determined. HMPL-689 drug exposures increased in a dose proportional fashion up to 30mg QD, as reflected in AUC and Cmax. The geometric mean AUCtau and Cmax at 30 mg QD in patients were approximately 2150 h•ng/mL and 260 ng/mL, respectively at steady state. The median Tmax was around 2 h and the arithmetic mean t1/2 was within the range of 5-10 hours, consistent across all dose levels.

51 out of the 56 patients had post-baseline tumor assessment, with 6 complete response (CR) (2 CLL/SLL, 4 FL), 21 partial responses (PR) (2 CLL/SLL, 5 MZL, 7 FL, 4 MCL, 3 DLBCL) and 18 stable disease (SD) (2 MZL, 9 FL, 4 MCL, 1 DLBCL, 2 HL). This resulted in 52.9% (27/51) objective response rate (ORR) in efficacy evaluable patients. The median time to response (TTR) and duration of response (DOR) were 3.5 months (1.8-8.4) and 6.4 months (0.7-NR), respectively (Table 3). One patient with FL who achieved CR (per post hoc independent radiologic review) was on treatment > 586 days. Final data quality control/verification is ongoing.

As a result, 30 mg QD of HMPL-689 has been selected as recommended phase 2 dose (RP2D) based on overall safety and tolerability, PK/PD and preliminary efficacy data.

 

Conclusions:

HMPL-689 was well tolerated and the RP2D was determined to be 30 mg QD orally. It exhibited dose-proportional pharmacokinetics, a manageable toxicity profile, and promising single-agent clinical activity in R/R B-cell lymphoma patients. The dose expansion study is ongoing, evaluating the safety and efficacy of HMPL-689 in patients with R/R B-cell lymphoma.

 

Acknowledgement

1. We would like to thank all patients and their families who participated in this trial;

2. We would like to thank all investigators, study coordinators and the entire project team.

Disclosures

Duan:Hutchison MediPharma Limitied: Current Employment. Yu:Hutchison MediPharma Limitied: Current Employment. Cai:Hutchison MediPharma Limitied: Current Employment. Su:Hutchison MediPharma Limited: Current Employment.