Inmagene Biopharmaceuticals Ltd.

SAN DIEGO, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Inmagene Biopharmaceuticals (Inmagene), a clinical-stage biotechnology company developing innovative and differentiated therapies for immunological and inflammatory (I&I) diseases, today announced it will host a virtual key opinion leader (KOL) event at 10:00 AM ET on Thursday, October 31, 2024. To register, click here. The event will feature Jonathan Silverberg, MD, PhD, MPH (The George Washington University School of Medicine and Health Sciences), Maryanne Senna, MD (Beth Israel Lahey Health, Harvard Medical School), and Yufang Lu, MD, PhD (Inmagene) who will discuss the potential role of anti-OX40/OX40L monoclonal antibodies (mAbs) in the treatment of atopic dermatitis (AD) and alopecia areata (AA). The event will discuss data from emerging OX40/OX40L inhibitors, including Inmagene’s IMG-007 - the only clinical-stage non-depleting anti-OX40 mAb. A live question and answer session will follow the formal presentations. About Jonathan Silverberg, MD, PhD, MPHJonathan Silverberg, MD, PhD, MPH is an Associate Professor of Dermatology at The George Washington University School of Medicine and Health Sciences in Washington, DC. He is the Director of Clinical Research and Contact Dermatitis. Dr. Silverberg completed his undergraduate and medical school training as a part of the highly selective dual B.A./M.D. program at State University of New York Downstate Medical Center, in Brooklyn. Dr. Silverberg also received his doctorate in neuroimmunology and Master of Public Health degree in biostatistics and epidemiology from the State University of New York Downstate Medical Center where he also completed his internship in internal medicine. He completed his residency training in dermatology at St. Luke's-Roosevelt Hospital Center and Beth Israel Medical Centers in New York, NY and served as Chief Resident during his final year. Dr. Silverberg's area of clinical subspecialty is inflammatory skin disease, particularly atopic and contact dermatitis. He has extensive experience in the advanced management of atopic dermatitis, hand eczema, chronic itch, psoriasis, hidradenitis and many other chronic inflammatory skin disorders. He is also a national expert in allergy patch testing, phototesting and photopatch testing. Dr. Silverberg's research interests include drug development, clinical trial design, biomarkers, dermato-epidemiology, health services research, patient-reported outcomes, comorbidities and burden of itch and inflammatory skin disease and evidence-based dermatology. His publications include more than 600 peer-reviewed articles, abstracts and book chapters. He is also the author of the Clinical Management of Atopic Dermatitis handbook (2018). Dr. Silverberg has also been a local, national and/or international principal investigator for numerous clinical trials for novel treatments in atopic dermatitis and other inflammatory disorders. He has been recognized with several honors, including the Young Leadership Award from the American Dermatological Association in 2017, Teacher of the Year Award in the department of dermatology in 2015, Outstanding Teacher's Award from the Feinberg School of Medicine in 2016, 2017 and 2018, and the inaugural Rajka Award from the International Society for Atopic Dermatitis in 2014. He is an associate editor for the Journal of the American Academy of Dermatology, British Journal of Dermatology and Current Dermatology Reports. Dr. Silverberg is a member of the International Eczema Council, North American Contact Dermatitis Group the American Society of Contact Dermatitis. Dr. Silverberg is also the chair of the annual Revolutionizing Atopic Dermatitis global multidisciplinary conference. About Maryanne Senna, MDMaryanne Senna, MD is a board-certified dermatologist at Beth Israel Lahey Health, and assistant professor of dermatology at Harvard Medical School. Dr. Senna founded and directs the Lahey Hair Loss Center of Excellence and serves as principal of the research unit. Prior to this role, she founded the MGH Hair Loss Clinic and clinical trials unit, which she ran for nearly 10 years. She has held a number of pharmaceutical, device, and foundation appointments. Widely published and recognized for her clinical expertise, teaching, and research, Dr. Senna is frequently invited to speak and give lectures nationally and abroad, and has been quoted in top-tier media publications such as The New York Times and The Atlantic. She has also been featured on multiple news outlets including Good Morning America, and in the HBO Max documentary series Not So Pretty. Dr. Senna is an esteemed member of several professional societies and committees, and is on the board of directors of the Scarring Alopecia Foundation, the American Hair Research Society, and on the medical advisory task force for the National Alopecia Areata Foundation. About Yufang Lu, MD, PhDYufang Lu is the Chief Medical Officer of Inmagene. Dr. Lu is an accomplished physician scientist with more than 20 years of experience in clinical development and medical affairs. She has successfully led clinical development for both small molecules and biologics across diverse therapeutic areas, including dermatology, allergy, gastroenterology, and rheumatology. Prior to Inmagene, Dr. Lu was Vice President of Clinical Development at Celldex, where she drove the advancement of innovative immunology assets, including barzovolimab. During her tenure at Regeneron, she led cross-functional medical teams in the global launches of Dupixent® in atopic dermatitis and asthma. Earlier in her career, she held roles in clinical development and medical affairs at Celgene, Eisai, and GSK. Dr. Lu received her medical degree from Nanjing Medical University with residency training in dermatology and a PhD in toxicology from Texas A&M University. About InmageneInmagene is a global clinical-stage biotechnology company developing novel therapeutics for I&I diseases. The company’s highly differentiated clinical-stage pipeline has multiple candidates with best-in-class potential. The lead asset IMG-007, a non-depleting anti-OX40 mAb, is in two global Phase 2a clinical trials in atopic dermatitis and alopecia areata. IMG-004, a non-covalent reversible BTK inhibitor with an extended half-life and pharmacodynamic effect, enabling its potential for once-daily dosing, recently completed the Phase 1 multiple ascending dose (MAD) study and is ready for Phase 2 development. For more information, please visit www.inmagenebio.com. About IMG-007IMG-007 is a humanized anti-OX40 IgG1 mAb, with an extended half-life and silenced antibody-dependent cellular cytotoxicity (ADCC) function. In nonclinical studies, IMG-007 potently blocked the signalling between OX40 and OX40L. IMG-007 is being evaluated for the treatment of moderate-to-severe atopic dermatitis (AD) and severe alopecia areata (AA). In a Phase 2a study in AD patients, a short 4-week treatment with IMG-007 resulted in a rapid and marked improvement in the extent and severity of skin lesions in AD patients. Interim data from a pharmacokinetic study showed that subcutaneous IMG-007 demonstrated an exceptionally long half-life, which would enable its potential for every six months (Q6M) dosing for AD maintenance therapy. Separately, its silenced ADCC function has led to a favorable safety profile, without any reports of pyrexia and chills, differentiating it from a competing ADCC-enhanced anti-OX40 mAb. Inmagene has in-licensed IMG-007’s exclusive global rights from HUTCHMED. Forward-Looking StatementsThis press release contains forward-looking statements. While Inmagene believes the projections to be based on reasonable assumptions, these forward-looking statements may be called into question by a number of hazards and uncertainties, so that actual results may differ materially from those anticipated in such forward-looking statements. For further information, please contact:Inmagene:Anna Vardanyan, MD, PhDSVP of Corporate and Business Developmentvardanyana@inmagenebio.com Investor Relations:Bruce MackleLifeSci Advisors, LLCbmackle@lifesciadvisors.com

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., July 31, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:​HCM; HKEX:​13) today reports its financial results for the six months ended June 30, 2024 and provides updates on key clinical and commercial developments. HUTCHMED to host results webcasts today at 8:00 a.m. EDT / 1:00 p.m. BST / 8:00 p.m. HKT in English, and at 8:30 a.m. HKT in Chinese (Putonghua) on Thursday, August 1, 2024. After registration, investors may access the live webcast via HUTCHMED’s website at www.hutch-med.com/event. All amounts are expressed in US dollars unless otherwise stated. Continued revenue momentum with substantial cash balance to support growth Reiterate full year 2024 guidance for Oncology/Immunology consolidated revenue of $300 to $400 million, with $168.7 million in the first half of 2024, driven by 59% (64% at CER1) oncology product revenue growth.FRUZAQLA® US in-market sales2 of $130.5 million in the first half of 2024 – demonstrating strong demand and commercial traction since launch in November 2023.Net income of $25.8 million in the first half of 2024. Cash balance of $802.5 million as of June 30, 2024, as we continued to prioritize key R&D3 projects and enhance commercial efficiency. Globalization of fruquintinib continues, broader pipeline makes strong progress Preparation for EU launch of FRUZAQLA® underway led by partner Takeda4 after European Commission approval in June 2024 – Filings in over a dozen jurisdictions supported by FRESCO-2.HUTCHMED preparing for China launch of sovleplenib for ITP5 – potentially its first hematology medicine, after the NDA6 was accepted and granted Priority Review status in January 2024.Potential US NDA filing for savolitinib for NSCLC7 at year end, based on SAVANNAH trial readout.NDAs accepted to expand use of ORPATHYS® and ELUNATE®, and for TAZVERIK® in China – for treatment-naïve METex148 NSCLC, endometrial cancer and follicular lymphoma, respectively.Key late-stage registration trials initiated with 15 ongoing/under review – across six drug candidates: ESLIM-02 for sovleplenib in warm AIHA9, RAPHAEL for HMPL-306 in AML10, and for surufatinib in PDAC11.Growing hematology portfolio with new programs targeting Menin and CD38, joining the existing portfolio of inhibitors and antibodies targeting Syk12, EZH213, IDH14, BTK15 and CD47. Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, “HUTCHMED has delivered strong performance in the first half of this year. The team has made significant progress implementing our strategy in discovering and developing novel, effective medicines; conducting clinical trials in our home market and in the global markets; and rapidly advancing regulatory and commercial goals. I am very pleased with the ongoing success of our partnership with Takeda and with the growing ability of the Company to provide health benefits to patients overseas. We have grown our revenues from the US during this period and we expect to see revenue growth from many other countries in the coming months. We are also capitalizing on our proven track record of bringing new medicines and additional indications for our marketed medicines to China, with several potential NDA approvals for the next few years.” “I would like to take this opportunity to express my appreciation to Mr Simon To, my predecessor, who has recently retired. Mr To has stood at the cradle of HUTCHMED and has made a very significant contribution to grow the Company and turn it into a global innovative player, discovering, developing and commercializing therapies for the treatment of cancer and immunological diseases, improving the quality of life of patients around the world. I look forward to guiding the Company along its next phase of growth, which is full of potential and promise.” 2024 INTERIM RESULTS & BUSINESS UPDATES Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, “The HUTCHMED team has been working tirelessly to continue the outstanding clinical and regulatory momentum that we have had in recent years, whilst importantly driving the commercial success of our approved products. I would like to extend my thanks to everyone for their hard work and commitment. Our oncology product revenue has grown 59% compared to the first half of 2023 and we are progressing a more focused R&D pipeline that has considerable potential for value creation. This year we initiated three key late-stage studies across our pipeline and are excited to be running over a dozen such studies that could support future drug approvals.” “The partnership strategy that we adopted for globalizing our medicines is allowing us to simultaneously fuel our in-house R&D engine, drive sales in our home market, and bring our medicines to patients in new geographies. Takeda’s impressive initial sales of FRUZAQLA® demonstrates both the quality of our medicines and their potential across the globe and our strategy of working with partners outside of our home market.” “We expect to advance our registration trials in the second half of the year. Around year end, we anticipate the potential approval of sovleplenib in China and potential NDA filing of savolitinib in the US. We will continue to progress towards becoming a self-sustaining biopharma business.” I. COMMERCIAL OPERATIONS Oncology in-market sales were up 140% (145% at CER) to $243.3 million (H1-23: $101.3m), which led to strong growth in consolidated oncology product revenue of 59% (64% at CER) to $127.8 million (H1-23: $80.1m), and mainly comprised of the following: FRUZAQLA® (fruquintinib ex-China) in-market sales were $130.5 million (H1-23: nil), which was launched in the US in November 2023. Its strong performance was due to rapid US patient uptake, as well as fulfilling sales channel inventory requirements;ELUNATE® (fruquintinib China) in-market sales increased 8% (13% at CER) to $61.0 million (H1-23: $56.3m), in line with CRC16 market growth, maintaining our leading market share position while weathering greater market competition;SULANDA® (surufatinib) in-market sales increased 12% (17% at CER) to $25.4 million (H1-23: $22.6m), as doctors’ awareness continues to increase, leading to greater NET patient access and market share; andORPATHYS® (savolitinib) in-market sales increased 18% (22% at CER) to $25.9 million (H1-23: $22.0m), as it benefited from improved testing and diagnosis for METex14 NSCLC and also ongoing growth momentum in the second year on the NRDL17. Oncology/​Immunology consolidated revenue comprised of consolidated oncology product revenue, which included product revenue, commercial service fees and royalties, as well as R&D income from our collaboration partners, mainly as follows: Takeda upfront, milestones and R&D services revenue were $33.8 million (H1-23: $269.1m), which included recognition of $19.4 million of the $435.0 million upfront and milestone payments already received from Takeda in cash during 2023. This compared to recognition of $258.7 million in the first half of 2023. As a result, total Oncology/Immunology consolidated revenue was $168.7 million (H1-23: $359.2m). Including Other Ventures revenue, total revenue was $305.7 million (H1-23: $532.9m). (Unaudited, $ in millions)In-market Sales*Consolidated Revenue** H1 2024H1 2023 %Δ(CER)H1 2024H1 2023 %Δ(CER)FRUZAQLA®$130.5 —— $42.8 —— ELUNATE® $61.0$56.3+8%(+13%)$46.0$42.0+9%(+14%)SULANDA® $25.4$22.6+12%(+17%)$25.4$22.6+12%(+17%)ORPATHYS® $25.9$22.0+18%(+22%)$13.1$15.1-14%(-10%)TAZVERIK®$0.5$0.4+40%(+46%)$0.5$0.4+40%(+46%)Oncology Products$243.3$101.3+140%(+145%)$127.8$80.1+59%(+64%)Takeda upfront, milestone and R&D services $33.8$269.1-87%(-87%)Other R&D services $7.1$10.0-29%(-27%)Total Oncology/​Immunology $168.7$359.2-53%(-52%)Other Ventures $137.0$173.7-21%(-18%)Total Revenue $305.7$532.9-43%(-41%) * = For FRUZAQLA®, ELUNATE® and ORPATHYS®, mainly represented total sales to third parties as provided by Takeda, Lilly18 and AstraZeneca, respectively.** = For FRUZAQLA®, represented drug product supply and royalties paid by Takeda; for ELUNATE®, represented drug product supply, commercial service fees and royalties paid by Lilly to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; for ORPATHYS®, represented drug product supply and royalties paid by AstraZeneca and sales to other third parties invoiced by HUTCHMED; for SULANDA® and TAZVERIK®, represented the Company’s sales of the products to third parties. II. REGULATORY UPDATES China Savolitinib sNDA19 accepted by NMPA20 for first-line and second-line METex14 NSCLC in 2024;Fruquintinib approved in Hong Kong for third-line CRC in January 2024;Fruquintinib sNDA accepted by NMPA with Priority Review for second-line endometrial cancer in early 2024;Tazemetostat approved in Hong Kong for R/R21 follicular lymphoma in May 2024; andTazemetostat NDA accepted by NMPA with Priority Review for R/R follicular lymphoma in July 2024. Ex-China Fruquintinib approved in the EU in June 2024, following positive opinion received from the EMA22 Committee for Medicinal Products for Human Use for previously-treated metastatic CRC in April 2024. III. LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES Savolitinib (ORPATHYS® in China), a highly selective oral inhibitor of MET23 Completed enrollment of SAVANNAH (NCT03778229), a Fast Track-designated pivotal global Phase II study for NSCLC patients who have progressed following TAGRISSO® due to MET amplification or overexpression, which may file in the US for accelerated approval. A small parallel study (NCT04606771) in this patient population presented data at AACR24 also demonstrated higher clinical activity with the combination therapy, with safety consistent with the known profiles of each treatment; andContinued enrolling SAFFRON (NCT05261399), a global, pivotal Phase III study in this patient population of the TAGRISSO® combination supporting SAVANNAH; SACHI (NCT05015608), a similar pivotal Phase III study for patients in China that progressed on EGFR25 inhibitor treatment, and SANOVO (NCT05009836), a pivotal Phase III study for first-line patients in China with EGFR mutation & MET overexpression. Potential upcoming clinical and regulatory milestones for savolitinib: Complete enrollment of SACHI in late 2024; andFile FDA26 NDA on SAVANNAH, subject to positive results, around year end 2024. Fruquintinib (ELUNATE® in China, FRUZAQLA® outside of China), a highly selective oral inhibitor of VEGFR27 1/2/3 designed to have enhanced selectivity that limits off-target kinase activity Presented results of FRUSICA-1, the registration Phase II study combined with sintilimab for patients with endometrial cancer with pMMR28 status, which showed meaningful efficacy improvements regardless of prior bevacizumab treatment and a manageable toxicity profile (NCT03903705);Presented FRESCO-2 subgroup analyses at ASCO29, biomarker analysis at AACR and quality-of-life analysis at ASCO GI30 (NCT04322539). Analyses showed that the treatment was effective regardless of prior therapy or sequence, that CEA31 response may be an early predictor of improved efficacy, and that it demonstrated clinically meaningful quality-adjusted survival benefit in patients with previously-treated CRC; andPublished in Nature Medicine the results of FRUTIGA, the study combined with paclitaxel for gastric cancer patients in China, concurrently with ASCO and following initial presentation at ASCO Plenary (NCT03223376). PFS32, ORR33 and DCR34 showed statistically significant improvements, and although OS35 improvement was not statistically significant overall, it was statistically significant in a pre-specified analysis excluding patients taking subsequent antitumor therapy. Potential upcoming clinical and regulatory milestones for fruquintinib: Complete PMDA36 NDA review for previously-treated metastatic CRC in late-2024; andAnnounce top-line results from the FRUSICA-2 Phase II/III registration trial in clear cell RCC37 around year end if the requisite number of PFS events is reached (NCT05522231). Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk, an important component of the Fc receptor and B-cell receptor signaling pathways Published ESLIM-01 (NCT05029635) results in adult patients with primary ITP in China in Lancet Haematology concurrently with presentations at EHA38. In addition to demonstrating a clinically meaningful early and sustained durable response of 48.4% and a tolerable safety profile, it significantly improved quality of life and showed consistent clinical benefits regardless of prior lines of therapies, prior TPO/TPO-RA39 exposure or treatment types;Published results of the Phase II proof-of-concept stage of a study in patients with warm AIHA in China at EHA, demonstrating a favorable safety profile and encouraging hemoglobin benefits; andInitiated ESLIM-02, the Phase III stage of the study, as a result of this positive data (NCT05535933). Potential upcoming clinical milestones for sovleplenib: Initiate a dose-finding study in ITP in the US/EU in mid-2024 (NCT06291415); andComplete ESLIM-01 NMPA NDA review around year end. Surufatinib (SULANDA® in China), an oral inhibitor of VEGFR, FGFR40 and CSF-1R41 designed to inhibit tumor angiogenesis and promote immune response against tumor cells via tumor associated macrophage regulation Initiated a Phase II/III trial for treatment-naïve metastatic PDAC in China, in combination with PD-142 antibody camrelizumab, nab-paclitaxel and gemcitabine (NCT06361888). This study was informed in part by an investigator-initiated trial presented at ASCO GI 2024 of a similar combination. This highly aggressive form of cancer has an estimated 511,000 people diagnosed annually worldwide. Tazemetostat (TAZVERIK® in Hainan, Macau and Hong Kong), a first-in-class, oral inhibitor of EZH2 Potential to complete China NDA review for R/R follicular lymphoma in mid-2025. HMPL-453, a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3 Continued enrolling the registrational Phase II trial for IHCC43 with FGFR 2 fusion (NCT04353375). HMPL-306, an investigative and highly selective oral dual-inhibitor of IDH1 and IDH2 enzymes, which have been implicated as drivers of certain hematological malignancies, gliomas and solid tumors Presented results from China and US/European Phase I studies at EHA, showing it as an effective treatment for IDH1 and/or IDH2-mutated R/R AML (NCT04272957, NCT04764474); andInitiated RAPHAEL Phase III Trial for IDH1- and/or IDH2-mutated R/R AML in China (NCT06387069). Other early-stage investigational drug candidates Presented preclinical and Phase I results at AACR, ASCO and EHA for ERK1/244 inhibitor HMPL-295, third-generation BTK inhibitor HMPL-760, Menin inhibitor HMPL-506, and CD38 ADC45 HMPL-A067; andInitiated Phase I trial for HMPL-506 for hematological malignancies in China (NCT06387082). IV. COLLABORATION UPDATES Further clinical progress by Inmagene46 with two candidates discovered by HUTCHMED Received approximately 7.5% of shares (fully diluted) in Inmagene following exercise of its option for an exclusive license to further develop, manufacture and commercialize IMG-007, a nondepleting anti-OX40 antibody, and IMG-004, a reversible, non-covalent, highly selective oral BTK inhibitor;Inmagene announced positive interim results from a Phase IIa trial of IMG-007 for atopic dermatitis. Treatment led to rapid, marked, and durable improvement of skin signs in patients with atopic dermatitis, while remaining well-tolerated overall. Final results are anticipated later in the third quarter of 2024. Inmagene also completed enrollment of a Phase IIa trial for alopecia areata; andInmagene announced positive topline results of a multiple ascending dose study with IMG-004, indicating once daily dosing potential. It was well tolerated, without reports of liver enzyme elevation or bleeding events, across once daily doses ranges for 10 days. Preliminary modeling and data support 50mg once daily as a potential therapeutic dose and further development as a differentiated treatment for BTK-mediated immunological diseases. V. OTHER VENTURES Other Ventures revenue is predominantly from our prescription drug distribution operation in China. Consolidated revenue decreased by 21% (18% at CER) to $137.0 million (H1-23: $173.7m) primarily as a result of lower COVID-related prescription drug distribution sales in 2024.SHPL47, a non-consolidated joint venture, saw revenue decrease by 4% (flat at CER) to $225.2 million (H1-23: $235.3m) mainly due to pricing reduction in a few higher-priced provinces to standardize the pricing structure of MUSKARDIA® in preparation for potential national implementation of volume-based procurement.Consolidated net income attributable to HUTCHMED from our Other Ventures decreased by 8% (4% at CER) to $34.1 million (H1-23: $37.2m), which was primarily due to decrease on the net income contributed from SHPL of $33.8 million (H1-23: $35.1m) as a result of price reduction impact from volume-based procurement, as well as increase in R&D spending.We continue to explore opportunities to monetize the underlying value of our SHPL joint venture including various divestment and collaboration alternatives. VI. SUSTAINABILITY HUTCHMED is committed to progressively embedding sustainability into all aspects of our operations and creating long-term value for our stakeholders. In April 2024, we published our 2023 Sustainability Report, which highlighted progress made in our 11 goals and targets; our enhanced climate actions including Scope 3 emissions screening and measurement and engaging with suppliers; our enhanced data quality; our strengthened alignment of our five most relevant and material sustainability pillars; and our enhanced disclosure and sector specific disclosure standards ahead of requirement. Wider recognition of HUTCHMED’s efforts have been reflected in steady improvements in major local and international sustainability ratings including from Hang Seng, ISS, MSCI, S&P Global, Sustainalytics and Wind. Recently, HUTCHMED scored 49 for S&P Global ESG48 Ratings, significantly higher than the industry average of 31. HUTCHMED also received the Best ESG(E) at the Hong Kong Investor Relations Association’s 10th Investor Relations Awards, two awards at Bloomberg Businessweek’s ESG Leading Enterprises event, five awards from Metro Finance’s GBA ESG Achievement Awards, and was listed amongst the Top 20 Chinese Pharmaceutical Listed Companies in ESG Competitiveness by Healthcare Executive. In 2024, we continue our efforts on the above areas and further strengthening our climate action by conducting a more comprehensive climate risk assessment to quantify the impact of climate risks in our major operations; incorporate sustainability into our corporate culture; and considering future goals and targets. FINANCIAL HIGHLIGHTS Foreign exchange impact: The RMB depreciated against the US dollar on average by approximately 4% during the first half of 2024, which has impacted our consolidated financial results as highlighted below. Cash, Cash Equivalents and Short-Term Investments were $802.5 million as of June 30, 2024 compared to $886.3 million as of December 31, 2023. Adjusted Group (non-GAAP49) net cash flows excluding financing activities in the first half of 2024 were ‑$51.3 million (H1-23: $219.3m), mainly due to $39.8 million net cash used in operating activities and $10.1 million of capital expenditure; andNet cash used in financing activities in the first half of 2024 totaled $32.6 million due to purchases for equity awards of $36.1 million (H1-23: net cash generated from financing activities of $5.8m). Revenue for the six months ended June 30, 2024 was $305.7 million compared to $532.9 million in the six months ended June 30, 2023. Oncology/Immunology consolidated revenue amounted to $168.7 million (H1-23: $359.2m) from: FRUZAQLA® revenue was $42.8 million, reflecting its successful US launch since early November 2023, comprising royalties and manufacturing revenue;ELUNATE® revenue increased 9% (14% at CER) to $46.0 million (H1-23: $42.0m) in its sixth year since launch, comprising of manufacturing revenue, promotion and marketing service revenue and royalties, which is in line with CRC market growth, maintaining our leading market share position while weathering greater market competition;SULANDA® revenue increased 12% (17% at CER) to $25.4 million (H1-23: $22.6m) continued sales growth after NRDL renewal as doctors’ awareness continues to increase, leading to greater NET patient access and market share;ORPATHYS® revenue decreased 14% (10% at CER) to $13.1 million (H1-23: $15.1m), due to a reduction in manufacturing revenue to $5.3 million (H1-23: $8.5m), offset by an increase in royalties to $7.8 million (H1-23: $6.6m) reflecting strong in-market sales growth of 18% (22% at CER);TAZVERIK® revenue was $0.5 million (H1-23: $0.4m) mainly from sales in the Hainan Pilot Zone50;Takeda upfront, milestones and R&D services revenue decreased to $33.8 million (H1-23: $269.1m, of which $258.7m was the recognized portion of the $400 million upfront cash payment received from Takeda in April 2023); andOther R&D services revenue of $7.1 million (H1-23: $10.0m), primarily related to fees from AstraZeneca and Lilly for the management of development and regulatory activities. Other Ventures consolidated revenue decreased 21% (18% at CER) to $137.0 million (H1-23: $173.7m), primarily as a result of lower COVID-related prescription drug distribution sales in 2024. This excluded non‑consolidated revenue at SHPL of $225.2 million (H1-23: $235.3m). Net Expenses for the six months ended June 30, 2024 were $279.9 million compared to $364.3 million in the six months ended June 30, 2023, reflecting our strong efforts on cost control. Cost of Revenue decreased by 14% to $180.1 million (H1-23: $208.3m), which was the net result of a reduction in cost of revenue from our Other Ventures, offset by the increase in product sales of our marketed products and the cost of promotion and marketing services for ELUNATE® resulting from the increased sales force;R&D Expenses reduced 34% to $95.3 million (H1-23: $144.6m), mainly due to the strategic prioritization of our pipeline, particularly outside China. Clinical and regulatory expenses in the US and Europe were $14.9 million (H1-23: $55.6m), while R&D expenses in China were $80.4 million (H1-23: $89.0m);S&A51 Expenses were $57.8 million (H1-23: $68.3m), which decreased primarily due to tighter control over our spending, while utilizing existing infrastructure to support further revenue growth; andOther Items mainly comprised of equity in earnings of SHPL, interest income and expense, FX and taxes, generated net income of $53.3 million (H1-23: $56.9m), which decreased primarily due to lower foreign currency exchange gains recognized in the period. Net Income attributable to HUTCHMED for the six months ended June 30, 2024 was $25.8 million compared to $168.6 million for the six months ended June 30, 2023. The net income attributable to HUTCHMED for the six months ended June 30, 2024 was $0.03 per ordinary share / $0.15 per ADS52, (H1-23: $0.20 per ordinary share / $1.00 per ADS). FINANCIAL GUIDANCE We reiterate full year 2024 guidance for Oncology/Immunology consolidated revenue is $300 million to $400 million, driven by 30% to 50% growth target in oncology marketed product revenue. HUTCHMED’s work in 2024 and beyond will be supported by its strong balance sheet. The Company is thus well placed to deliver against its target to become a self-sustaining business and its goal to bring its innovative medicines to patients globally through its own sales network in China markets and through partners worldwide. Shareholders and investors should note that: we do not provide any guarantee that the statements contained in the financial guidance will materialize or that the financial results contained therein will be achieved or are likely to be achieved; andwe have in the past revised our financial guidance and reference should be made to any announcements published by us regarding any updates to the financial guidance after the date of publication of this announcement. 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” for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively. FINANCIAL SUMMARY Condensed Consolidated Balance Sheets Data (in $’000)As ofJune 30, 2024 As ofDecember 31, 2023Assets(Unaudited) Cash and cash equivalents and short-term investments802,453 886,336Accounts receivable156,916 116,894Other current assets88,891 93,609Property, plant and equipment94,815 99,727Investment in an equity investee80,519 48,411Other non-current assets37,274 34,796Total assets1,260,868 1,279,773Liabilities and shareholders’ equity Accounts payable43,398 36,327Other payables, accruals and advance receipts249,218 271,399Deferred revenue108,777 127,119Bank borrowings82,100 79,344Other liabilities25,357 22,197Total liabilities508,850 536,386Company’s shareholders’ equity740,084 730,541Non-controlling interests11,934 12,846Total liabilities and shareholders’ equity1,260,868 1,279,773 Condensed Consolidated Statements of Operations Data (Unaudited, in $’000, except share and per share data)Six months ended June 30, 2024 2023 Revenue: Oncology/Immunology – Marketed Products127,796 80,149 Oncology/Immunology – R&D40,841 279,034 Oncology/Immunology consolidated revenue168,637 359,183 Other Ventures137,044 173,691 Total revenue305,681 532,874 Operating expenses: Cost of revenue(180,135) (208,324)Research and development expenses(95,256) (144,633)Selling and administrative expenses(57,811) (68,263)Total operating expenses(333,202) (421,220) (27,521) 111,654 Other income, net22,765 25,434 (Loss)/income before income taxes and equity in earnings of an equity investee(4,756) 137,088 Income tax expense(2,886) (2,730)Equity in earnings of an equity investee, net of tax33,807 35,110 Net income26,165 169,468 Less: Net income attributable to non-controlling interests(364) (917)Net income attributable to HUTCHMED25,801 168,551 Earnings per share attributable to HUTCHMED (US$ per share) – basic 0.03 0.20 – diluted0.03 0.19 Number of shares used in per share calculation – basic856,030,704 846,928,863 – diluted872,534,466 866,990,610 Earnings per ADS attributable to HUTCHMED (US$ per ADS) – basic 0.15 1.00 – diluted0.15 0.97 Number of ADSs used in per share calculation – basic171,206,141 169,385,773 – diluted174,506,893 173,398,122 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 it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology medicines marketed in China, the first of which is also marketed in the US. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Contacts Investor Enquiries+852 2121 8200 / ir@hutch-med.com Media Enquiries Ben Atwell / Alex Shaw, FTI Consulting+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.comZhou Yi, Brunswick+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley / Rupert Dearden, Panmure Liberum+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 US 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 have been obtained will continue to remain valid and effective in the future, 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; discovery, development and/or commercialization of 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 pandemics and disease outbreaks. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, on AIM and on HKEX53. 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 (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018). Medical Information This announcement contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. This announcement in its entirety is available at:http://ml.globenewswire.com/Resource/Download/584882e0-cb55-4c65-8b21-f088947ccfee _________________ REFERENCES & ABBREVIATIONS1CER = 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.2In-market sales = total sales to third parties provided by Eli Lilly (ELUNATE®), Takeda (FRUZAQLA®), AstraZeneca (ORPATHYS®) and HUTCHMED (ELUNATE®, SULANDA®, ORPATHYS® and TAZVERIK®).3R&D = Research and development.4Takeda = Takeda Pharmaceuticals International AG, a subsidiary of Takeda Pharmaceutical Company Limited.5ITP = immune thrombocytopenia purpura.6NDA = New Drug Application.7NSCLC = Non-small cell lung cancer.8METex14 = MET exon 14 skipping alterations.9AIHA = Autoimmune hemolytic anemia.10AML = Acute myeloid leukemia.11PDAC = Pancreatic ductal adenocarcinoma.12Syk = Spleen tyrosine kinase.13EZH2 = Enhancer of zeste homolog 2.14IDH = Isocitrate dehydrogenase.15BTK = Bruton’s tyrosine kinase.16CRC = Colorectal cancer.17NRDL = China National Reimbursement Drug List.18Lilly = Eli Lilly and Company.19sNDA = Supplemental New Drug Application.20NMPA = China National Medical Products Administration.21R/R = Relapsed and/or refractory.22EMA = European Medicines Agency.23MET = Mesenchymal epithelial transition factor.24AACR = American Association for Cancer Research Annual Meeting.25EGFR = Epidermal growth factor receptor.26FDA = Food and Drug Administration.27VEGFR = Vascular endothelial growth factor receptor.28pMMR = Proficient mismatch repair.29ASCO = American Society of Clinical Oncology Annual Meeting.30ASCO GI = ASCO Gastrointestinal Cancers Symposium.31CEA = Carcinoembryonic antigen.32PFS = Progression free survival.33ORR = Objective response rate.34DCR = Disease control rate.35OS = Overall survival.36PMDA = Pharmaceuticals and Medical Devices Agency.37RCC = Renal cell carcinoma.38EHA = European Hematology Association.39TPO/TPO-RA = Thrombopoietin and/or thrombopoietin receptor agonists.40FGFR = Fibroblast growth factor receptor.41CSF-1R = Colony-stimulating factor 1 receptor.42PD-1 = Programmed cell death protein-1.43IHCC = Intrahepatic cholangiocarcinoma.44ERK = Extracellular signal-regulated kinase.45ADC = Antibody-drug conjugate.46Inmagene = Inmagene Biopharmaceuticals.47SHPL = Shanghai Hutchison Pharmaceuticals Limited.48ESG = Environmental, Social and Governance.49GAAP = Generally Accepted Accounting Principles.50Hainan Pilot Zone = Hainan Boao Lecheng International Medical Tourism Pilot Zone.51S&A= Selling and administrative expenses.52ADS = American depositary share.53HKEX = The Main Board of The Stock Exchange of Hong Kong Limited.

· IMG-004 在每日一次 (QD) 50mg至 300mg给药10 天的剂量范围内耐受性良好,所有测试剂量的关键肝功能参数均保持在正常参考范围内, 未报告出血事件 · 所有 QD 剂量组均于给药间隔期间维持了强劲的药效学 (PD) 效应 ，初步药代动力学 /药效学（PK/PD） 模型支持 50mg QD 作为潜在的治疗剂量 · 数据支持 IMG-004 作为 BTK 介导的免疫疾病的差异化治疗方案的进一步开发 圣地亚哥，加利福尼亚，2024年6月29日——创响生物(Inmagene Biopharmaceuticals, 下简称“创响”)宣布了其强效、非共价、可逆且可透脑的布鲁顿酪氨酸激酶 (BTK) 抑制剂IMG-004，在随机、双盲、安慰剂对照的1期研究中多次递增剂量 (MAD) 部分的积极顶线结果。 之前在健康成人中进行的30 至 600mg的 1 期单次递增剂量（SAD）研究显示，IMG-004 耐受性良好，终末半衰期为 26 至 37 小时，具有强劲的 PD 效应，这支持进一步探索 IMG-004的 QD 剂量方案。 当前1期 MAD 研究评估了 IMG-004 在 24 名健康成人中的安全性、PK 和 PD。受试者接受了 IMG-004 50 mg、150 mg、300 mg或安慰剂 QD 治疗 10 天。研究显示，最高至300mg的IMG-004 QD 剂量耐受性良好。未报告重度或严重不良事件 (SAE)。除一例轻微便秘不良事件(AE)外，所有不良事件均被判定为与研究治疗无关。没有报告出血事件。此外，关键肝功能测试，包括天冬氨酸转氨酶 (AST)、丙氨酸转氨酶 (ALT) 和总胆红素，在所有测试的 QD 剂量中均保持在正常参考范围内。 IMG-004 的血浆暴露量与剂量大致成比例。使用体外嗜碱性粒细胞抑制试验进行的药效学评估表明，在所有 QD 剂量组的整个给药间隔内均观察到高水平抑制，且抑制持续至少 24 小时。 本研究中测试的所有三个剂量在达稳态后其整个给药间隔的暴露量均达到了基于PK/PD模型预估的至少90% 的最大抑制浓度 (IC90)。综合起来，数据支持 IMG-004 的潜在治疗剂量方案为 50 mg QD，相对于良好耐受的最高测试剂量300mg QD，具有非常宽的安全范围。 “我们对研究结果非常满意。迄今为止，BTK 抑制剂已在近十种 I&I 适应症中得到临床验证。然而，该类药物受到安全隐患和用药不方便的限制，”创响首席医学官陆雨芳博士表示，“IMG-004在本研究显示的强大而持久的 BTK 抑制效应和良好的安全性使其具有成为同类最佳的潜力，并允许在广泛的 QD 剂量范围内进行探索，以确定最佳剂量方案。” 关于创响生物 创响生物是一家全球化临床阶段的生物技术公司，专注于免疫及炎症疾病领域的新药开发。该公司高度差异化的临床阶段管线拥有多个具有同类最佳潜力的候选药物。先导化合物IMG-007，一种非耗竭性抗OX40的单克隆抗体，正在特应性皮炎和斑秃患者中进行两项全球2a期临床研究。IMG-004是一种非共价、可逆的BTK抑制剂，具有超长的半衰期和药效学效应，使其具有每天给药一次的潜力，且准备进入2期开发。IMG-008是一种针对IL-36R的长效单克隆抗体，目前正在进入全球 1 期临床开发。 更多信息，请访问www.inmagenebio.com。 关于IMG-004 IMG-004 是一种针对 BTK 的非共价可逆小分子抑制剂。IMG-004为通常需要长期治疗的免疫和炎症疾病而设计，具有强效、高选择性和脑渗透性。在对健康受试者进行的单次递增剂量 (SAD) 研究中，IMG-004 的半衰期为 26-37 小时，比大多数领先的 BTK 抑制剂更长。此外，它的持续药效学效应支持每日一次给药的潜力。IMG-004 计划开发治疗慢性自发性荨麻疹和化脓性汗腺炎。IMG-004 最初由和黄医药( HUTCHMED) 发现，创响从候选阶段起承担开发责任。