ROCKVILLE, Md. and SUZHOU, China, April 2, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, and HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today jointly announce that the New Drug Application ("NDA") for the combination of sintilimab and fruquin ...

Regulatory and Clinical Developments - The New Drug Application (NDA) for the combination of fruquintinib and sintilimab for advanced endometrial cancer has been accepted and granted priority review by the China National Medical Products Administration (NMPA) [1] - This is the first regulatory filing for fruquintinib in combination with an immune checkpoint inhibitor [3] - The NMPA granted Breakthrough Therapy designation to the combination in July 2023, recognizing its potential to address a serious condition with no effective treatment options [3] - The NDA is supported by data from the FRUSICA-1 study, a Phase II trial investigating the combination in endometrial cancer patients who failed prior systemic therapy [2] Endometrial Cancer Overview - Endometrial cancer is a common gynecological malignancy, with an estimated 417,000 global cases and 97,000 deaths in 2020 [4] - In China, approximately 82,000 people were diagnosed with endometrial cancer, resulting in 17,000 deaths in 2020 [4] - Recurrent and metastatic endometrial cancer remains an area of high unmet need with limited treatment options [4] Fruquintinib Profile - Fruquintinib is a selective oral inhibitor of VEGFR-1, -2, and -3, designed to inhibit tumor angiogenesis with enhanced selectivity and manageable safety [5] - It is approved in China for metastatic colorectal cancer and included in the National Reimbursement Drug List (NRDL) since January 2020 [6][7] - In the US, fruquintinib (marketed as FRUZAQLA™) received approval in November 2023 for metastatic colorectal cancer, supported by Phase III trials FRESCO and FRESCO-2 [8] Sintilimab Profile - Sintilimab, marketed as TYVYT® in China, is a PD-1 monoclonal antibody co-developed by Innovent and Eli Lilly [9] - It is approved in China for seven indications, including non-small cell lung cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma [9] - The combination of sintilimab and fruquintinib for advanced endometrial cancer has been granted priority review by the NMPA [10] Company Overview - HUTCHMED is a biopharmaceutical company focused on developing targeted therapies and immunotherapies for cancer and immunological diseases, with approximately 5,000 employees globally [11] - Innovent is a leading biopharmaceutical company with a mission to provide affordable biologics, having launched 10 products and with multiple assets in clinical development [12] Clinical Trial Data - The FRUSICA-1 study evaluated fruquintinib in combination with sintilimab in endometrial cancer patients, with primary and secondary endpoints including ORR, DCR, DoR, PFS, and OS [2] - Data from FRUSICA-1 will be presented at an upcoming medical conference [2]

— Oral presentation at the European Lung Cancer Congress 2024 of Phase IIIb data demonstrating median PFS of 13.7 months and median OS not reached in treatment-naïve patients — — If approved, would confirm 2021 conditional approval and expand indication to more patients — HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the supplemental New Drug Application ("sNDA") for savolitinib, ...

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 22, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated the registration stage of the Phase II/III clinical trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia ("wAIHA") in China. This follows positive data from the proof-of-concept Phase II stage of the trial and subsequent consultation with the China National Medical Products Administratio ...

HUTCHMED (China) Limited (NASDAQ:HCM) Q4 2023 Results Conference Call February 28, 2024 7:30 AM ET Company Participants Mark Lee - Senior Vice President of Corporate Management & Communications Dr. Wei-Guo Su - CEO, Chief Scientific Officer Johnny Cheng - CFO Zhenping Wu - Executive Vice President of Pharmaceutical Science & Manufacturing Michael Shi - Executive VP, Head of R&D and Chief Medical Officer Conference Call Participants Louise Alesandra Chen - Cantor Fitzgerald & Co Alec Warren Stranahan - Bank ...

Financial Performance - Total revenue for 2023 reached $838 million, representing a 97% increase (102% at constant exchange rates) compared to the previous year[2]. - Net income for the year was $101 million, with a significant contribution from the oncology/immunology business, which saw a 223% revenue increase to $528.6 million[6]. - The company has a strong cash position, ending 2023 with $886.3 million, up from $631 million in 2022[6]. - Total revenue for 2023 increased by 97% to $838 million, driven by collaboration with Takeda and strong commercialization in China[9]. - The oncology/immunology business revenue grew by 223% to $528.6 million, benefiting from a $280 million collaboration revenue from Takeda and strong product sales growth[10]. - The company reported a net cash flow of $206.7 million for 2023, a significant improvement from a negative $297.9 million in 2022[33]. - The company’s total assets grew to $1.28 billion in 2023, up from $1.03 billion in 2022[36]. - The net income attributable to Hutchmed per ordinary share was $0.12 in 2023, compared to a loss of $0.43 per share in 2022[38]. - The company’s cash, cash equivalents, and short-term investments increased by $255 million to $886.34 million as of December 31, 2023[39]. - The company’s net expenses for 2023 were $737.2 million, a decrease from $787.2 million in 2022[33]. Product Development and Approvals - The FDA approved the drug FRUZAQLA™ (fruquintinib) for third-line colorectal cancer, leading to a market launch by Takeda with initial sales of $915.1 million[5]. - The new drug application for sovleplenib for primary immune thrombocytopenia has been accepted in China and is under priority review[6]. - The company plans to submit a new drug application for fruquintinib in second-line gastric cancer in China, with recruitment for clinical trials completed[6]. - The successful ESLIM-01 study for Syk inhibitor in immune thrombocytopenia has led to a new drug application accepted for priority review in January 2024[8]. - The company aims to submit a new drug application for savolitinib in Q1 2024, expanding its label indications in China[8]. - The new drug application for the combination therapy of fruquintinib and paclitaxel for second-line treatment of gastric cancer was accepted in April 2023[16]. - Fruquintinib received FDA approval in November 2023 for the treatment of previously treated metastatic colorectal cancer patients[16]. - The EMA submission for the treatment of previously treated metastatic colorectal cancer is expected to be completed by mid-2024[18]. - The company plans to submit a new drug application for the treatment of primary immune thrombocytopenia in mid-2024[21]. - The company has initiated a Phase II study for gastric cancer patients with MET amplification in China[17]. Strategic Collaborations and Partnerships - The company is focused on advancing its product pipeline and strategic partnerships, evidenced by a $435 million upfront and milestone payments from Takeda[5]. - The strategic collaboration with Takeda is noted as one of the largest small molecule licensing deals in China's biopharmaceutical history, enhancing the company's cash flow[7]. - Takeda is responsible for the global development, production, and commercialization of furmonertinib outside of mainland China, Hong Kong, and Macau, with potential payments to the company of up to $1.13 billion[26]. - The company received a $400 million upfront payment from Takeda in April 2023, along with potential milestone payments totaling up to $730 million[26]. Research and Development - The company has 13 oncology candidates currently in clinical trials, supported by a team of approximately 900 scientists and staff[51]. - The company continues to maintain the same pricing for 爱优特® in the national medical insurance drug list for the new two-year agreement starting January 2024[53]. - The company has initiated three Phase III studies for Savolitinib, including the SACHI and SANOVO studies launched in 2021 and the SAFFRON global pivotal study started in 2022[65]. - The company has successfully obtained FDA approval for Furmonertinib in November 2023, marking a significant milestone in its global market strategy[63]. - The company is exploring the use of furmonertinib in various solid tumors, with approximately 90 ongoing clinical trials in China[86]. Market Performance - Market sales of ELUNATE® (furmonertinib) in China increased by 15% to $107.5 million, maintaining a leading market share[10]. - FRUZAQLA™ (furmonertinib) generated $15.1 million in market sales following its U.S. launch in November 2023[10]. - Sales of SULANDA® (surufatinib) rose by 36% to $43.9 million, reflecting increased market share two years after inclusion in the national medical insurance catalog[12]. - ORPATHYS® (savolitinib) sales grew by 12% to $46.1 million, with a 30% increase in sales in the last three quarters of 2023 compared to the same period in 2022[12]. - The market sales of innovative oncology products grew by 28% to $213.6 million in 2023, compared to $167.1 million in 2022, with a fixed exchange rate growth of 35%[52]. Operational Highlights - The company aims to establish a self-sustaining business model while navigating global economic uncertainties[7]. - The company has completed patient recruitment for a Phase II study of furmonertinib in July 2023, with plans to submit a new drug application to the National Medical Products Administration by mid-2024 if results are positive[84]. - The company has received fast track designation from the FDA for savolitinib for treating pancreatic and non-pancreatic neuroendocrine tumors, although a new drug application was not approved[89]. - The company has conducted clinical trials of savolitinib in approximately 2,900 patients, with promising data from several studies presented at ASCO and ESMO conferences in 2023[88]. Sustainability and Governance - The independent 2023 sustainability report will be published alongside the 2023 annual report in April 2024, detailing the company's sustainability measures and performance[165]. - The company has complied with all applicable provisions of the Corporate Governance Code as of December 31, 2023[168]. - The company is committed to transparency and has complied with the ethical responsibilities outlined in the professional code of conduct[183].

Revenue grew 97% (102% CER) to US$838 million, with net income of US$101 million First U.S. FDA approval of our self-developed medicine, FRUZAQLA™ (fruquintinib) Sovleplenib for ITP accepted for NDA review in China, with Priority Review status and Breakthrough Therapy designation HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED", the "Company" or "we") (Nasdaq/AIM:​HCM; HKEX:​13), the innovative, commercial-stage biopharmaceutical co ...

Financial Performance - Total revenue increased by 97% (102% at CER) to $838 million for 2023, with net income of $101 million[7]. - Revenue for the year ended December 31, 2023, was $838.0 million, compared to $426.4 million in 2022, representing a significant increase[22]. - Total revenue for 2023 reached $837,999,000, a significant increase of 96.5% compared to $426,409,000 in 2022[180]. - Net income attributable to HUTCHMED for 2023 was $100.8 million, compared to a net loss of $360.8 million in 2022, resulting in earnings of $0.12 per ordinary share[25]. - The company reported a total comprehensive income of $94,502,000 for 2023, compared to a comprehensive loss of $368,855,000 in 2022[182]. - The company achieved a basic earnings per share of $0.12 in 2023, recovering from a loss of $0.43 in 2022[180]. Oncology/Immunology Revenue - Oncology/Immunology consolidated revenue rose by 223% (228% at CER) to $528.6 million, driven by a $280 million upfront payment from Takeda[4]. - Oncology/Immunology consolidated revenue increased 223% to $528.6 million, driven by strong sales of ELUNATE, FRUZAQLA™, and SULANDA[23]. - The company expects full year 2024 Oncology/Immunology consolidated revenue to be between $300 million and $400 million, driven by a growth target of 30% to 50% in oncology marketed product revenue[29]. - In-market sales for ELUNATE (fruquintinib in China) increased by 15% (22% at CER) to $107.5 million[7]. - In-market sales of HUTCHMED's oncology products grew by 28% to $213.6 million in 2023, compared to $167.1 million in 2022[40]. Research and Development - Fruquintinib received U.S. FDA approval for third-line colorectal cancer (CRC) in November 2023, leading to U.S. in-market sales of $15.1 million[2]. - Fruquintinib NDA for second-line gastric cancer accepted for review in China, with expected NDA filing for endometrial cancer in early 2024[3]. - Sovleplenib NDA for primary immune thrombocytopenia (ITP) accepted in China with priority review status, supported by Phase III trial data[3]. - Savolitinib's pivotal global Phase II trial (SAVANNAH) completed enrollment, with potential NDA filing to the U.S. FDA expected by the end of 2024[3]. - The company plans to submit an NDA for savolitinib in early 2024 and complete several pivotal studies by late 2024[11][12][13]. - Tazemetostat is expected to file for NDA in late 2024 for relapsed/refractory follicular lymphoma, following successful studies[15]. Cash and Financial Position - Cash balance strengthened to $886.3 million at year-end 2023, up from $631 million in 2022, positioning the company for self-sustainability[4]. - Cash, cash equivalents, and short-term investments were $886.3 million as of December 31, 2023, up from $631.0 million in 2022[22]. - The company reported net cash generated from operating activities of $219.3 million, a significant improvement from a net cash used of $268.6 million in 2022, reflecting a net change of $487.9 million[132]. - The company reported a net cash used in investing activities of $291.1 million for 2023, compared to net cash generated of $296.6 million in 2022, indicating a net change of $587.7 million[133]. - The company had a net cash generated from financing activities of $48.7 million in 2023, a significant improvement from a net cash used of $82.8 million in 2022[134]. Cost and Expenses - Cost of revenue increased by 24% to $384.4 million, with Oncology/Immunology costs rising by 33% to $91.7 million due to increased product sales[24]. - R&D expenses reduced by 22% to $302.0 million, reflecting the completion of several large trials and a strategic focus on partnerships[24]. - Operating expenses for 2023 totaled $819.624 million, a slight decrease from $834.102 million in 2022[28]. - The Group's total staff costs for the year ended December 31, 2023, were $213.7 million, a decrease from $227.2 million in 2022[156]. Partnerships and Collaborations - Takeda partnership generated $435 million in upfront and milestone payments, enhancing the company's cash position and strategic pipeline[2]. - The company has partnered with Takeda for the development and commercialization of fruquintinib outside of China, with potential payments up to $1.13 billion, including $400 million received upon closing the agreement[76]. - HUTCHMED has received $85 million from AstraZeneca as part of a collaboration agreement for savolitinib, with potential total payments of $140 million[52]. Market and Product Developments - FRUZAQLA™ launched in the U.S. on November 8, 2023, with in-market sales reaching $15.1 million by the end of 2023, exceeding expectations for new patient starts[42]. - SULANDA's in-market sales increased by 36% to $43.9 million in 2023, compared to $32.3 million in 2022, maintaining a 21% prescription share in NET treatment[44]. - ORPATHYS sales grew by 12% to $46.1 million in 2023, with a significant increase of 104% in volume during the latter part of the year following NRDL listing[48]. - ELUNATE continues to be included in the NRDL for a new two-year term starting January 2024 at the same price as 2023[42]. Clinical Trials and Results - Savolitinib's Phase II trial for MET exon 14 skipping alterations in NSCLC showed an overall response rate (ORR) of 60.7% and a disease control rate (DCR) of 95.2%[57]. - The VIKTORY study for savolitinib in MET-driven gastric cancer reported a 50% ORR in patients with MET amplification[59]. - The SAMETA study for MET-driven PRCC is ongoing, with over 140 sites in more than 20 countries enrolling patients[62]. - The FRESCO-2 study demonstrated a statistically significant increase in overall survival (OS) and progression-free survival (PFS) in 691 patients, with a median OS of 9.3 months for fruquintinib versus 6.6 months for placebo[65]. - In the FRUTIGA study, patients receiving fruquintinib combined with paclitaxel achieved a median PFS of 5.6 months compared to 2.7 months for the control group, with a hazard ratio (HR) of 0.569 and p < 0.0001[71]. Strategic Focus and Future Plans - The company has utilized 50% of net proceeds ($292.7 million) for advancing late-stage clinical programs and expanding its product portfolio in cancer and immunological diseases[166]. - 20% of net proceeds ($117.1 million) was directed towards strengthening commercialization, clinical, regulatory, and manufacturing capabilities, as well as potential global business development and strategic acquisitions[166]. - The company plans to submit results for tazemetostat in follicular lymphoma for NDA filing in late 2024[86].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark one) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...

Shares of HUTCHMED (HCM) have gained 2.2% over the past four weeks to close the last trading session at $14.59, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $25.54 indicates a potential upside of 75.1%.The average comprises five short-term price targets ranging from a low of $14.60 to a high of $45, with a standard deviation of $12.20. While the lowest estimate indicates an i ...