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Strong execution on strategic direction, delivering near-term value while charting a path for growth, exemplified by global partnership with Takeda

Revenue grew 164% (173% CER) to US$533 million, with net income to HUTCHMED of US$169 million (which include US$259 million of the upfront recognized from Takeda)

Company to Host Interim Results Call & Webcast Today at 8 p.m. HKT / 1 p.m. BST / 8 a.m. EDT

Company to host a Capital Markets Day in Q4 this year

 

Hong Kong, Shanghai & Florham Park, NJ — Monday, July 31, 2023: HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:​HCM; HKEX:​13), the innovative, commercial-stage biopharmaceutical company, today reports its unaudited financial results for the six months ended June 30, 2023 and provides updates on key clinical and commercial developments.

All amounts are expressed in U.S. dollars unless otherwise stated.

 

Strategic: clinical, financial, /and regulatory progress demonstrates strong delivery on the strategy

 

Product & pipeline: fruquintinib advancing to global launches, with continued progress across portfolio

 

Financial: HUTCHMED remains on track to become self-sustaining in 2025

 

2023 Interim Results & Business Updates

Mr Simon To, Executive Chairman of HUTCHMED, said, “The first half of 2023 has been successful for HUTCHMED. In late 2022, we announced our pipeline prioritization plan and intention to seek global partners to bring our medicines to help patients outside of China. Six months later, this strategy is already delivering significant results to our operations. We are successfully navigating the current challenging capital markets, while making significant progress towards our goal of becoming a self-sustaining, truly global biopharma company. Crucially, it means that we are well positioned to reach more patients than ever with our medicines.”

“In March, we closed a licensing deal for fruquintinib with Takeda and we are confident that they have the commitment, expertise, and commercial infrastructure to successfully roll out this innovative medicine to patients across the globe. The FDA Priority Review PDUFA date for fruquintinib is now set for November 30 this year, reflecting its potential to deliver significant improvement over currently available treatments.”

 

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, “With the sharpening of our goals and priorities, we now have more resources to advance our assets and drive near-term value, and we are pleased to report on the important progress made so far this year. We have over 15 registration/​registration-intent studies ongoing with seven drug candidates. Alongside this, our team has presented data at a number of leading medical conferences, including AACR[14], ASCO[15], ASCO GI[16], EHA[17] and ICML[18], showcasing the productivity of our world class R&D engine. Furthermore, commercial performance has remained strong this year, with robust sales growth of our in-house developed oncology products in China. All three marketed medicines are now included on the NRDL, in line with our commitment to patient access. Moreover, our strategy means we are in a strong financial position as we look to continue developing our clinical programs. We started the second half of 2023 with $856 million in cash resources, including the $400 million received from Takeda.”

“HUTCHMED is now well placed for further successful product launches and life cycle extensions. In particular, we look forward to continuing the positive momentum with fruquintinib regulatory reviews around the world, and readouts from our registration studies for sovleplenib and amdizalisib later this year. As the last six months have shown, HUTCHMED clearly has the right strategy, leadership team, and vision to become a truly global biopharma, and I am confident that HUTCHMED will continue to deliver on this potential.”

 

I. COMMERCIAL OPERATIONS

Total revenues increased 164% (173% at CER) to $532.9 million in the first half of 2023 (H1-22: $202.0m), driven by Oncology/Immunology partnering, its strong commercial progress in China, and growth in third-party distribution sales.

Oncology/Immunology consolidated revenues were up 294% (301% at CER) to $359.2 million (H1-22: $91.1m); driven by recognition of $258.7 million in partnering revenue for the upfront payment from Takeda, and our strong product sales growth resulting from in-market sales[19] up 16% (25% at CER) to $101.3 million (H1‑22: $87.4m);

II. REGULATORY UPDATES

China

 

Ex-China

 

III. CLINICAL DEVELOPMENT ACTIVITIES

Savolitinib (ORPATHYS® in China), a highly selective oral inhibitor of MET being developed broadly across MET-driven patient populations in lung, gastric and papillary renal cell carcinomas

Potential upcoming clinical and regulatory milestones for savolitinib:

 

Fruquintinib (ELUNATE® in China), a highly selective oral inhibitor of VEGFR[27] 1/2/3 designed to improve kinase selectivity to minimize off-target toxicity and thereby improve tolerability

Potential upcoming clinical and regulatory milestones for fruquintinib:

 

Surufatinib (SULANDA® in China), an oral inhibitor of VEGFR, FGFR[30] and CSF-1R[31] designed to inhibit tumor angiogenesis and promote immune response against tumor cells via tumor associated macrophage regulation

 

Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk[32], an important component of the Fc receptor and B-cell receptor signaling pathway

Potential upcoming clinical milestones for sovleplenib:

 

Amdizalisib (HMPL-689), an investigative and highly selective oral inhibitor of PI3Kδ[35] designed to address the gastrointestinal and hepatotoxicity associated with currently approved and clinical-stage PI3Kδ inhibitors

Potential upcoming clinical and regulatory milestones for amdizalisib:

 

Tazemetostat (TAZVERIK® in Macau and the Hainan Pilot Zone), a first-in-class, oral inhibitor of EZH2 licensed from Ipsen[36] subsidiary Epizyme[37] in China

Potential upcoming clinical and regulatory milestones for tazemetostat:

 

HMPL-453, a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3

 

Earlier stage investigational drug candidates

In addition to the seven drug candidates being developed in over 15 registration studies above, HUTCHMED is developing six further oncology candidates in early-stage clinical trials. These are HMPL-306, a highly selective oral inhibitor of IDH1/2[38] designed to address resistance to currently marketed IDH inhibitors; HMPL-760, a highly selective, third-generation oral inhibitor of BTK[39] with improved potency versus first generation BTK inhibitors against both wild type & C481S mutant enzymes; HMPL-295, a highly selective oral inhibitor of ERK[40] in the MAPK pathway[41] with the potential to address intrinsic or acquired resistance from upstream mechanisms such as RAS-RAF-MEK; HMPL-653, an oral, highly selective, and potent CSF-1R inhibitor designed to target CSF-1R driven tumors as a monotherapy or in combinations; HMPL-A83, a differentiated, red blood cell sparing anti-CD47 antibody; and HMPL-415, a novel SHP2 allosteric inhibitor that entered clinical trials in July 2023.

Subject to data and consultation with the CDE[42], several of these earlier stage drug candidates have potential to move into registration trials in the next 12 months.

 

IV. COLLABORATION UPDATES

Closed Exclusive Worldwide License to Takeda for Fruquintinib Outside China

 

Further clinical progress by Inmagene with two candidates discovered by HUTCHMED

 

V. OTHER VENTURES

Other Ventures include our profitable prescription drug marketing and distribution platforms

 

VI. IMPACT OF COVID-19

While restrictive measures related to COVID-19 were gradually lifted in China starting from December 2022, COVID-19 had some impact on our research, clinical studies and our commercial activities in the first months of 2023. Measures were put in place to reduce the impact and, in the second quarter of 2023, these activities normalized.

 

VII. SUSTAINABILITY

At HUTCHMED, we are committed to a progressive journey as we continue to grow. This includes embedding sustainability into all aspects of our operations and creating long-term value for our stakeholders, including our staff, our communities and our shareholders. In April 2023, we published our 2022 Sustainability Report alongside our 2022 Annual Report. This year we continue to make progress in line with the commitments and outcomes outlined in the report, including achieving satisfactory progress to date towards the 11 short- to long-term sustainability goals and targets and following the recommended disclosure framework of the Task Force on Climate-related Financial Disclosures (TCFD) in line with the risks assessment. In the second half of 2023, we continue enhancing our climate risks action by conducting scope 3 emissions screening, introducing a digital data collection platform, and further strengthening our sustainability-related disclosures.

 

Financial Highlights

Foreign exchange impact: The RMB depreciated against the U.S. dollar on average by approximately 7% during the six months ended June 30, 2023, which has impacted our consolidated financial results as highlighted below.

Cash, Cash Equivalents and Short-Term Investments were $856.2 million as of June 30, 2023 compared to $631.0 million as of December 31, 2022.

 

Revenues for the six months ended June 30, 2023 were $532.9 million compared to $202.0 million in the six months ended June 30, 2022.

 

Net Expenses for the six months ended June 30, 2023 were $364.3 million compared to $364.9 million for the six months ended June 30, 2022.

 

Net Income attributable to HUTCHMED for the six months ended June 30, 2023 was $168.6 million (which include $258.7 million of the upfront payment recognized from Takeda) compared to Net Loss attributable to HUTCHMED of $162.9 million for the six months ended June 30, 2022.

 

Financial Summary

FINANCIAL GUIDANCE

Following the closing of the license with Takeda and having received from them the upfront payment of $400 million, we currently expect to recognize approximately $280 million in 2023.

We provide financial guidance for Oncology/Immunology consolidated revenues, reflecting expected revenue growth of our oncology products in China; R&D services income from our partners AstraZeneca, Lilly and Takeda; potential milestone payments on fruquintinib U.S. regulatory approval; and the above-mentioned recognition of the upfront payment from Takeda. We believe that we remain on track to meet the 2023 guidance provided in the announcement of our 2022 full year results on February 28, 2023.

Shareholders and investors should note that:

———

Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the “Use of Non-GAAP Financial Measures and Reconciliation” below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.

Conference call and audio webcast presentation scheduled today at 8 p.m. HKT / 1 p.m. BST / 8 a.m. EDT. After registering, investors may access a live audio webcast of the call via HUTCHMED’s website at www.hutch-med.com/event/.

Participants who wish to join the call by telephone and ask a question must register. Upon registration, each participant will be provided with dial-in numbers and a unique PIN.

HUTCHMED intends to host a Capital Markets Day in the fourth quarter of this year to further update the market on its progress following the strategy change, and to showcase the exciting pipeline of drug candidates.

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM: ​HCM; HKEX: ​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, 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, HUTCHMED has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology medicines now approved and marketed in China. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.

Contacts

Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 306-4490
Media Enquiries
Americas – Brad Miles, Solebury Strategic Communications +1 (917) 570 7340 (Mobile) / bmiles@soleburystrat.com
Europe – Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com
Asia – Zhou Yi, Brunswick +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley / Daphne Zhang,
Panmure Gordon		 +44 (20) 7886 2500

 

References

Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “HUTCHMED,” “HUTCHMED Group,” “we,” “us,” and “our,” mean HUTCHMED (China) Limited and its subsidiaries unless otherwise stated or indicated by context.

Past Performance and Forward-Looking Statements

The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. 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 can be identified by words like “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “pipeline,” “could,” “potential,” “first-in-class,” “best-in-class,” “designed to,” “objective,” “guidance,” “pursue,” or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by 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. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, that any approvals which are obtained will be obtained at any particular time, or that the sales of products marketed or otherwise commercialized by HUTCHMED and/or its collaboration partners (collectively, “HUTCHMED’s Products”) will achieve any particular revenue or net income levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally, including, among others, the risk that HUTCHMED’s ADSs could be barred from trading in the United States as a result of the Holding Foreign Companies Accountable Act and the rules promulgated thereunder; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the inability of a drug candidate to meet the primary or secondary endpoint of a study; the inability of a drug candidate to obtain regulatory approval in different jurisdictions or the utilization, market acceptance and commercial success of HUTCHMED’s Products after obtaining regulatory approval; competing products and drug candidates that may be superior to, or more cost effective than, HUTCHMED’s Products and drug candidates; the impact of studies (whether conducted by HUTCHMED or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of HUTCHMED’s Products and drug candidates in development; the ability of HUTCHMED to manufacture and manage supply chains for multiple products and drug candidates; the availability and extent of reimbursement of HUTCHMED’s Products from third-party payers, including private payer healthcare and insurance programs and government insurance programs; the costs of developing, producing and selling HUTCHMED’s Products; the ability of HUTCHMED to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries, uncertainties regarding future global exchange rates and uncertainties regarding the impact of COVID-19. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and on HKEX[46]. HUTCHMED is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

In addition, this announcement contains statistical data and estimates that HUTCHMED obtained from industry publications and reports generated by third-party market research firms. Although HUTCHMED believes that the publications, reports and surveys are reliable, HUTCHMED has not independently verified the data and cannot guarantee the accuracy or completeness of such data. You are cautioned not to give undue weight to this data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above.

Inside Information

This announcement contains inside information for the purposes of Article 7 of Regulation (E.U.) No 596/2014 (as it forms part of retained E.U. law as defined in the European Union (Withdrawal) Act 2018).

 

Ends

[1] Takeda = Takeda Pharmaceuticals International AG.

[2] NDA = New Drug Application.

[3] FDA = Food and Drug Administration.

[4] PDUFA = U.S. Prescription Drug User Fee Act.

[5] MAA = Marketing Authorization Application.

[6] EMA = European Medicines Agency.

[7] CRC = Colorectal cancer.

[8] NRDL = National Reimbursement Drug List.

[9] IHCC = Intrahepatic cholangiocarcinoma.

[10] SHP2 = Src homology-2 domain-containing protein tyrosine phosphatase-2.

[11] CER = Constant exchange rate. We also report changes in performance at CER which is a non-GAAP measure. Please refer to “Use of Non-GAAP Financial Measures and Reconciliation” below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures.

[12] R&D = Research and development.

[13] SG&A expenses = Selling, general and administrative expenses.

[14] AACR = American Association for Cancer Research.

[15] ASCO = American Society of Clinical Oncology.

[16] ASCO GI = ASCO (American Society of Clinical Oncology) Gastrointestinal Cancers Symposium.

[17] EHA = European Hematology Association.

[18] ICML = International Conference on Malignant Lymphoma.

[19] In-market sales = total sales to third parties provided by Eli Lilly (ELUNATE®), AstraZeneca (ORPATHYS®) and HUTCHMED (ELUNATE®, SULANDA®, ORPATHYS® and TAZVERIK®).

[20] Lilly = Eli Lilly and Company.

[21] NMPA = National Medical Products Administration.

[22] PMDA = Pharmaceuticals and Medical Devices Agency.

[23] NSCLC = Non-small cell lung cancer.

[24] MET = Mesenchymal epithelial transition factor.

[25] EGFR = Epidermal growth factor receptor.

[26] PRCC = Papillary renal cell carcinoma.

[27] VEGFR = Vascular endothelial growth factor receptor.

[28] PD-1 = Programmed cell death protein-1.

[29] RCC = Renal cell carcinoma.

[30] FGFR = Fibroblast growth factor receptor.

[31] CSF-1R = Colony-stimulating factor 1 receptor.

[32] Syk = Spleen tyrosine kinase.

[33] AIHA = Autoimmune hemolytic anemia.

[34] ITP = Immune thrombocytopenia purpura.

[35] PI3Kδ = Phosphoinositide 3-kinase delta.

[36] Ipsen = Ipsen SA, parent of Epizyme Inc.

[37] Epizyme = Epizyme Inc., a wholly owned subsidiary of Ipsen SA.

[38] IDH = Isocitrate dehydrogenase.

[39] BTK = Bruton’s tyrosine kinase.

[40] ERK = Extracellular signal-regulated kinase.

[41] MAPK pathway = RAS-RAF-MEK-ERK signaling cascade.

[42] CDE = Center for Drug Evaluation.

[43] SHPL = Shanghai Hutchison Pharmaceuticals Limited.

[44] GAAP = Generally Accepted Accounting Principles.

[45] ADS = American depositary share.

[xlvi] HKEX = The Main Board of The Stock Exchange of Hong Kong Limited.

Date: July 31, 2023 (Monday)
Announcement release: 7am EDT / 12 noon BST / 7pm HKT
View Announcement
Presentation webcast & call: 8am EDT / 1pm BST / 8pm HKT
 
Listen to the Webcast Replay
For investors and analysts who wish to join the call by phone, please use the below registration link to obtain the dial-in details :  Phone dial-in registration

 

Hong Kong, Shanghai & Florham Park, NJ — Thursday, July 20, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to the combination of fruquintinib and sintilimab (a PD-1 antibody) for the treatment of patients with advanced endometrial cancer (“EMC”) with pMMR1 tumors that have failed at least one line of platinum-based therapy. A study for potential registration of this combination in patients with previously treated advanced EMC in China has recently completed enrollment.

It is a multi-center, open-label clinical study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab. Entry criteria include those EMC patients who experienced disease recurrence, disease progression or grade 3 or higher serious adverse events with treatment on platinum-based chemotherapy. The primary endpoint is independent review committee (IRC) assessed objective response rate (“ORR”), with secondary endpoints including disease control rate (“DCR”), progression free survival (“PFS”), overall survival (“OS”), as well as pharmacokinetic (PK) assessments. A total of 142 previously treated, advanced EMC patients were enrolled. Additional details may be found at clinicaltrials.gov, using identifier NCT03903705.

Favorable results from this trial could lead to submission to the NMPA in the first half of 2024 for regulatory approval in this treatment setting.

About Breakthrough Therapy Designation in China

NMPA grants BTD to new drugs that treat life-threatening diseases or serious conditions for which there are no effective treatment options, and where clinical evidence demonstrates significant advantages over existing therapies. Drug candidates with BTD may be considered for conditional approval and priority review when submitting a New Drug Application (“NDA”). This indicates that the development and review of the therapy for this disease indication may be expedited, to address patients’ unmet needs more quickly.

About EMC

EMC is a type of cancer that begins in the uterus. Globally, an estimated 417,000 people were diagnosed with EMC and it caused approximately 97,000 deaths in 2020.2 Іn China, an estimated 82,000 people were diagnosed with EMC and it caused approximately 17,000 deaths in 2020.3 Although early-stage EMC can be surgically resected, recurrent and/or metastatic EMC remains an area of high unmet need with poor outcomes and limited treatment options.4,5,6

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor (“VEGFR”) -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity with the intention of minimizing off-target toxicities, improving tolerability and providing more consistent target coverage. Fruquintinib has been generally well tolerated in patients to date and is being investigated in combinations with other anti-cancer therapies.

Fruquintinib was approved for marketing by the NMPA in September 2018 and commercially launched in China in November 2018 under the brand name ELUNATE® for the treatment of patients with metastatic colorectal cancer (“CRC”) who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild type). It has been included in the National Reimbursement Drug List (“NRDL”) since January 2020.

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.

Filing of a rolling submission of NDA to the U.S. Food and Drug Administration (“FDA”) was accepted and granted priority review in May 2023 with a Prescription Drug User Fee Act (PDUFA) date of November 30, 2023. Submission to the European Medicines Agency (EMA) was validated in June 2023, and submission to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) is expected to be completed in 2023. The submissions to the FDA and the EMA include results from the Phase III FRESCO-2 trial along with data from the Phase III FRESCO trial conducted in China. 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 CRC. The FRESCO-2 trial met its primary and key secondary endpoints, showing a significant and clinically meaningful improvement in OS and PFS, respectively. Fruquintinib has been generally well tolerated in patients to date (NCT04322539).7

An NDA to the NMPA was accepted in April 2023 for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma. The NDA includes results from the Phase III FRUTIGA trial, a study in China to evaluate fruquintinib combined with paclitaxel compared with paclitaxel monotherapy in this patient population. Its dual-primary endpoints were PFS and OS. The trial met the PFS endpoint at a statistically and clinically meaningful level, and while there was an improvement in median OS, the OS endpoint was not statistically significant. Statistically significant improvements were also shown in secondary endpoints including ORR, DCR and duration of response (DoR). The safety profile was consistent with previously reported studies (NCT03223376). 

HUTCHMED is also developing fruquintinib in China for the treatment of multiple other solid tumor cancers in combination with anti-PD-1 monoclonal antibodies. Fruquintinib is licensed to Takeda Pharmaceutical Company Limited outside of China. HUTCHMED markets fruquintinib in China in partnership with Eli Lilly and Company.

About Sintilimab

Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent Biologics, Inc. and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells.8 Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved for seven indications and included in the NRDL for six indications.

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 oncology drugs now approved and marketed in China. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.

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 HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of fruquintinib in combination with sintilimab for the treatment of patients with advanced EMC 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 sufficiency of clinical data to support NDA approval of fruquintinib in combination with sintilimab for the treatment of patients with advanced EMC in China, the U.S., Europe, Japan, Australia or other jurisdictions, its potential to gain expeditious approvals from regulatory authorities, the safety profile of fruquintinib, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for fruquintinib, the timing of these events, 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 paclitaxel, tislelizumab and sintilimab as combination therapeutics with fruquintinib, 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 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.

Reference

[1] pMMR = Mismatch Repair proficient

[2] The Global Cancer Observatory, World Fact Sheet.  Accessed June 12, 2023.

[3] The Global Cancer Observatory, China Fact Sheet. Accessed June 12, 2023.

[4] Yi A, et al. Real-world characteristics and treatment pattern of patients with newly diagnosed endometrial cancer in China.  J Clin Oncol. 2023;41, no. 16_suppl (June 01, 2023) e17613-e17613. DOI: 10.1200/JCO.2023.41.16_suppl.e17613.

[5] Koppikar S, et al. Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with endometrial cancer. ESMO Open. 2023;8(1):100774. DOI:10.1016/j.esmoop.2022.100774.

[6] Siegel RL, et al. Cancer statistics, 2023. CA Cancer J Clin. 2023;73(1):17-48. DOI:10.3322/caac.21763.

[7] Dasari NA, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study [published online ahead of print, 2023 Jun 15]. Lancet. 2023. DOI: 10.1016/S0140-6736(23)00772-9.

[8] Wang J, Fei K, Jing H, et al. Durable blockade of PD-1 signaling links preclinical efficacy of sintilimab to its clinical benefit. mAbs 2019;11(8): 1443-1451. DOI: 10.1080/19420862.2019.1654303.

Contacts

Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 306 4490

Media Enquiries
Americas – Brad Miles,
Solebury Strategic Communications		 +1 (917) 570 7340 (Mobile)
bmiles@soleburystrat.com
Europe – Ben Atwell / Alex Shaw,
FTI Consulting		 +44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile)
HUTCHMED@fticonsulting.com
Asia – Zhou Yi,
Brunswick		 +852 9783 6894 (Mobile)
HUTCHMED@brunswickgroup.com

Nominated Advisor
Atholl Tweedie / Freddy Crossley / Daphne Zhang,
Panmure Gordon		 +44 (20) 7886 2500

Ms Ling Yang to replace Mr Lefei Sun as Non-executive Director; Professor Solange Peters appointed as Special Advisor to the Technical Committee
 

Hong Kong, Shanghai & Florham Park, NJ — Thursday, July 13, 2023: HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM:HCM, HKEX:13) today announces that with effect from July 13, 2023:

(i) Mr Lefei Sun, having left his position at General Atlantic, has resigned as Non-executive Director and member of the Technical Committee of HUTCHMED; and

(ii) Ms Ling Yang, managing director of The Carlyle Group and co-head of Carlyle Asia Healthcare, has been appointed as Non-executive Director of HUTCHMED and will hold office until the next general meeting when she will stand for re-election.

The Board of Directors of HUTCHMED (the “Board”) is of the view that the appointment of Ms Yang would provide significant benefits to HUTCHMED taking into consideration her experience in biotechnology company management, business strategy, capital markets and mergers and acquisitions. Ms Yang had been the managing director of Carlyle and co-head of Carlyle Asia Healthcare since November 2021, in charge of advising in healthcare investment and portfolio activities of Carlyle in China. Carlyle owns approximately 4.7% of the ordinary shares of HUTCHMED, through its affiliate CA Fern Parent.

Mr Simon To, Chairman of HUTCHMED said “On behalf of the Board, we would like to express our gratitude and appreciation to Mr Lefei Sun for his contributions to the Company and we wish him all the best for his future endeavors. We welcome Ms Ling Yang to the Company. We believe that her expertise in life sciences and healthcare investment would strengthen our Board as it works towards achieving its goals.”

Ms Yang, aged 43, is chairwoman and non-executive director of ADICON Holdings Limited (HKEX: 9860); director of Shenzhen Salubris Pharmaceuticals Co., Ltd. (SZSE: 002294); non-executive director of Ambio Pharmaceuticals and Ambio, Inc.; chairwoman of Adicon (Hangzhou) Clinical Laboratories Co., Ltd. and Aidiken (Hangzhou) Biotech Co., Ltd; and director of Adicon International Limited and Manson Grand International Limited. She was previously non-executive director of Ambio Holdings, Inc. Ms Yang previously worked at KKR Asia Limited at which her last position was a principal primarily responsible for carrying out investments made by KKR Asia Limited. She also worked as an associate in the U.S. leveraged buyout healthcare group of Carlyle; and as an analyst in the investment banking division of The Goldman Sachs Group, Inc. She graduated summa cum laude and is a member of Phi Beta Kappa with a bachelor’s degrees in economics and computer science from Smith College and she received her master of business administration degree from Harvard Business School.

Under the terms of her appointment, Ms Yang will serve as a Non-executive Director of the Company until the next general meeting. As a Non-executive Director, she will not receive any fees for her service and that her appointment will be renewed for successive 12-month periods, unless she is not re-elected at the next general meeting or her appointment is otherwise terminated earlier by either party in writing.

Save for the appointment listed above, Ms Yang has held no other directorships or partnerships during the period of five years prior to her appointment as a director of HUTCHMED. Save for her role with Carlyle, she does not have any relationship with any Directors, senior management or substantial or controlling shareholders of HUTCHMED. Ms Yang does not have any interest in the ordinary shares of HUTCHMED within the meaning of Part XV of the Securities and Futures Ordinance (Cap.571 of the Laws of Hong Kong).

Save for the information disclosed above, there is no other information in relation to Ms Yang that is required to be disclosed pursuant to Rule 17 and Schedule 2(g) of the AІM Rules for Companies or Rule 13.51(2) of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited (“HK Listing Rules”) and there are no other matters concerning the appointment of Ms Yang that are required to be brought to the attention of the shareholders of HUTCHMED.

Pursuant to the requirements of Rule 13.51(2) of the HK Listing Rules, Mr Sun has confirmed that he has no disagreement with the Board and that there are no other matters that need to be brought to the attention of the shareholders of the Company in connection with his resignation from the Board.

 

Appointment of Special Advisor to the Technical Committee

With respect to the announcements made on May 10, 2023 and May 12, 2023 on changes in board positions and committee membership of the Company, the Board had decided to appoint Professor Solange Peters as Special Advisor to the Technical Committee of the Company with effect from July 12, 2023. This decision follows further consideration by the Board and discussions with Professor Peters. Professor Peters will not join the Board.

Taking into account the expertise and reputation of Professor Peters in biopharmaceutical research in oncology and in immunology, the Board is of the view that her appointment as Special Advisor to the Technical Committee (instead of the position of an Independent Non-executive Director, as previously proposed) would enable Professor Peters to contribute most effectively to the scientific research and strategy of HUTCHMED.

Mr Simon To, Chairman of HUTCHMED said “The Board warmly welcomes the appointment of Professor Peters as Special Advisor to the Technical Committee, and looks forward to working with her. We believe that her extensive experience in oncology and immunology would be of immense value to the Company as it develops drugs for the treatment of diseases in these fields.”

 

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 oncology drugs now approved and marketed in China. 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 risk that current or future appointees to HUTCHMED’s board of directors are not effective in their respective positions, the difficulty in locating and recruiting suitable candidates for its board of directors and the management difficulties which may arise from changes in HUTCHMED’s board of directors. 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 AІM and with The Stock Exchange of Hong Kong Limited. 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
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 306 4490

Media Enquiries
Americas – Brad Miles,
Solebury Strategic Communications		 +1 (917) 570 7340 (Mobile)
bmiles@soleburystrat.com
Europe – Ben Atwell / Alex Shaw,
FTI Consulting		 +44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile)
HUTCHMED@fticonsulting.com
Asia – 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 — Monday, July 10, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a Phase I study in China of HMPL-415, an investigational novel selective allosteric inhibitor targeting Src homology-2 domain-containing protein tyrosine phosphatase-2 (“SHP2”). The first patient received their first dose on July 6, 2023.

The clinical trial is a multi-center, open-label study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy profile of HMPL-415 as a single agent in patients with advanced malignant solid tumors. This study is expected to enroll up to approximately 80 patients, including patients as part of the dose escalation stage, and further patients at the determined recommended Ph II dose (RP2D). The leading principal investigators are Dr. Tianshu Liu of Zhongshan Hospital Fudan University and Dr. Nong Yang of Hunan Cancer Hospital. Additional details may be found at clinicaltrials.gov, using identifier NCT05886374.

 

About HMPL-415

HMPL 415 is a novel, highly potent and selective allosteric inhibitor targeting SHP2. SHP2 is a non-receptor protein tyrosine phosphatase ubiquitously expressed mainly in the cytoplasm of several tissues. SHP2 modulates diverse cell signaling events that control metabolism, cell growth, differentiation, cell migration, transcription and oncogenic transformation. It interacts with diverse molecules in the cell, and regulates key signaling events including RAS/ERK, PI3K/AKT, JAK/STAT and PD-1 pathways downstream of several receptor tyrosine kinases (RTKs) upon stimulation by growth factors and cytokines. Dysregulation of SHP2 expression or activity causes many developmental diseases, and hematological and solid tumors1.

HUTCHMED currently retains all rights to HMPL-415 worldwide.

 

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 more than 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 oncology drugs now approved and marketed in China. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.

 

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 HUTCHMED’s current expectations regarding future events, includ­ing its expectations regarding the thera­peutic potential of HMPL-415, the further clinical develop­ment for HMPL-415, its expectations as to whether any studies on HMPL-415 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 enrollment rates and the 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 HMPL-415, including as a combination therapy, 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 market of HMPL-415 for a targeted indication; the sufficiency of funding; 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.

 

Reference

[1] Asmamaw, M.D., Shi, XJ., Zhang, LR. et al. A comprehensive review of SHP2 and its role in cancer. Cell Oncol. 45, 729–753 (2022). https://doi.org/10.1007/s13402-022-00698-1

 

Contacts

Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 306 4490

Media Enquiries
Americas – Brad Miles,
Solebury Strategic Communications		 +1 (917) 570 7340 (Mobile)
bmiles@soleburystrat.com
Europe – Ben Atwell / Alex Shaw,
FTI Consulting		 +44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile)
HUTCHMED@fticonsulting.com
Asia – Zhou Yi,
Brunswick		 +852 9783 6894 (Mobile)
HUTCHMED@brunswickgroup.com

Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon		 +44 (20) 7886 2500