Core Insights - The SACHI Phase III trial confirms the efficacy of the savolitinib and osimertinib combination in treating advanced NSCLC patients with MET amplification after prior EGFR-TKI treatment [1][3][4] - The combination received regulatory approval in China in June 2025, indicating a significant advancement in treatment options for this patient population [2][18] Company Overview - HUTCHMED is a biopharmaceutical company focused on developing targeted therapies and immunotherapies for cancer and immunological diseases, with its first three medicines marketed in China [21] - Savolitinib (ORPATHYS®) is a selective MET TKI developed in collaboration with AstraZeneca, while osimertinib (TAGRISSO®) is a third-generation EGFR TKI [2][9][12] Trial Details - The SACHI trial involved 211 patients, with a median progression-free survival (PFS) of 8.2 months for the combination therapy compared to 4.5 months for chemotherapy, demonstrating a significant improvement [4][5] - The objective response rate (ORR) was 58% for the combination therapy versus 34% for chemotherapy, and the disease control rate (DCR) was 89% compared to 67% [5] Efficacy and Safety - In the third-generation EGFR TKI-naïve subgroup, the median PFS was 9.8 months for the combination versus 5.4 months for chemotherapy, further supporting the treatment's efficacy [6] - The safety profile of the combination was tolerable, with no new safety signals observed, and treatment-emergent adverse events of Grade 3 or above were similar between the two treatment arms [7] Market Context - Lung cancer is the leading cause of cancer death, with NSCLC accounting for 80-85% of cases, and a significant portion of patients exhibiting EGFR mutations [8] - MET amplification is a known resistance mechanism to EGFR TKIs, making the combination of savolitinib and osimertinib a promising strategy for addressing this challenge [8][17]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完整性亦不發表任何聲明，並明確表示，概 不對因本公告全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 HUTCHMED (China) Limited 和黃醫藥（中國）有限公司 （於開曼群島註冊成立的有限公司） （股份代號：13） 自願性公告 和黃醫藥宣佈SACHI III期研究結果於《柳葉刀 (The Lancet)》發表 ― 首個隨機III期臨床試驗證實MET抑制劑在伴有獲得性MET擴增的既往EGFR TKI治療後疾病進展的 晚期非小細胞肺癌患者中的療效 — — 賽沃替尼和奧希替尼的聯合療法於2025年6月在中國獲批 — 和黃醫藥（中國）有限公司（簡稱「和黃醫藥」或 「HUTCHMED」）今日宣佈SACHI III期研究的結果於《柳葉刀 （The Lancet）》發表。SACHI是一項賽沃替尼（savolitinib ，沃瑞沙®/ORPATHYS®）和奧希替尼（osimertinib ， 泰瑞沙®/TAGRISSO®）的聯合療法用於治療伴有MET擴增的接受一線表皮生長因子受體（「EGFR」）酪氨酸激酶 ...

Core Viewpoint - In 2025, despite a significant market downturn, the Hang Seng Healthcare Index maintained an annual increase of over 50%, while Hutchison China MediTech (00013) experienced an annual decline of 8.56%, underperforming the index significantly [1] Group 1: Stock Performance - Hutchison China MediTech's stock reached a peak increase of only 36.36% in 2025, with a notable decline in the second half of the year, where the stock price fell from a high of HKD 30.75 to a low of HKD 19.95, marking a maximum drop of 35.12% over four and a half months [1] - The stock showed a rebound at the beginning of 2026, achieving a "five consecutive days of gains" with a peak single-day trading volume of 15.45 million shares, the highest since October of the previous year [1] Group 2: Financial Performance - In the 2025 mid-year report, the company reported revenues of USD 278 million, a year-on-year decrease of 9.2%. However, due to the sale of non-core joint venture equity, net profit surged to USD 455 million, a 16.6-fold increase [2] - The sales of the company's three main innovative drugs, including Fuzulopatinib, Surufatinib, and Savolitinib, saw a significant decline of 30-50%, leading to a 22% year-on-year drop in self-owned product sales [2] Group 3: Market Sentiment and Trading Behavior - Following the mid-year report, the stock price underwent a month-long adjustment, with a brief recovery in mid-September, but this was interrupted by a decline in the Hang Seng Healthcare Index [3] - The stock exhibited a "follow the market down" behavior, with a shift in trading style among investors, particularly in the Hong Kong Stock Connect, which began to align more closely with the stock's price movements starting in November [5] Group 4: Pipeline and Future Prospects - The decline in stock performance in 2025 was attributed to the lack of commercial performance from the main innovative drugs, creating a gap in the second half of the year [7] - The company has developed a diversified pipeline from oncology to autoimmune diseases, with several candidates entering critical clinical stages, including Sovleplenib, HMPL-453, HMPL-306, and HMPL-506 [7] - Recent updates on the progress of new and existing pipeline products have driven the stock's rebound, with significant announcements regarding new drug applications and clinical trial advancements [8][9] Group 5: Specific Drug Developments - Sovleplenib, a selective oral SYK inhibitor, is expected to be approved this year for the treatment of refractory/relapsed primary immune thrombocytopenia (ITP), potentially generating new revenue streams [9] - HMPL-453, a selective and potent FGFR1/2/3 inhibitor, is anticipated to be approved by 2027, indicating a long-term growth potential for the company [10]

Group 1 - HUTCHMED (HCM) closed at $13.75, with a 0.2% gain over the past four weeks, and analysts set a mean price target of $21.44, indicating a 55.9% upside potential [1] - The average price targets range from a low of $13.75 to a high of $32.00, with a standard deviation of $7.81, suggesting variability in analyst estimates [2] - Analysts have shown increasing optimism regarding HCM's earnings prospects, with a strong agreement in revising EPS estimates higher, which correlates with potential stock price movements [11][12] Group 2 - The Zacks Consensus Estimate for HCM has increased by 14.6% over the past month, indicating positive sentiment among analysts [12] - HCM holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, suggesting strong potential for upside [13] - While consensus price targets may not be reliable for predicting exact gains, they can indicate the direction of price movement, which appears to be positive for HCM [14]

Core Insights - HUTCHMED (China) Limited announced positive data from the Phase 3 registration part of the ESLIM-02 clinical trial for sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) [1][4] Clinical Trial Results - The ESLIM-02 trial met its primary endpoint of durable hemoglobin response rate between weeks 5 to 24 of treatment [2] - The overall response rate was 43.8% in the first 8 weeks and 66.7% during the 24 weeks of treatment, compared to 0% in the placebo group [4] - The study included patients who had relapsed or were refractory to at least one prior line of standard treatment [3] Disease Prevalence and Impact - The incidence of autoimmune hemolytic anemia (AIHA) is estimated at 0.8-3.0 per 100,000 adults annually, with a prevalence of 17 per 100,000 adults and a death rate of 8-11% [2] - wAIHA accounts for approximately 75-80% of all adult AIHA cases [2] Regulatory Plans - HUTCHMED plans to submit a New Drug Application for sovleplenib for wAIHA to the China National Medical Products Administration (NMPA) in the first half of 2026 [4] Competitive Landscape - Novartis AG reported results from the VAYHIT2 Phase 3 trial showing that ianalumab plus eltrombopag had a median time to treatment failure 2.8 times longer than placebo plus eltrombopag [6] - CRISPR Therapeutics AG initiated a Phase 1 trial of its allogeneic CAR T therapy in ITP and wAIHA [6] Other Developments - HUTCHMED initiated the Phase 3 part of a trial for a combination treatment for metastatic pancreatic ductal adenocarcinoma [7] - HUTCHMED shares increased by 5.09% to $14.45 during premarket trading [7]

Core Viewpoint - Hutchison China MediTech Limited (和黄医药) shares rose over 3%, currently up 3.1% at HKD 21.98, with a trading volume of HKD 44.32 million [1] Group 1: Clinical Research - On January 7, Hutchison China MediTech announced that its Syk inhibitor, Sola-pinib, has met the primary endpoint of durable hemoglobin (Hb) response during the 5 to 24 weeks treatment period in the ESLIM-02 study for adult patients with warm antibody autoimmune hemolytic anemia [1] - The ESLIM-02 study is a randomized, double-blind, placebo-controlled clinical trial conducted in China for adult patients with relapsed or refractory primary or secondary warm antibody autoimmune hemolytic anemia who have received at least one standard treatment [1] - The results of the Phase II portion of the ESLIM-02 study were published in The Lancet Haematology in January 2025 [1] Group 2: Future Plans - Hutchison China MediTech plans to submit a new drug application for Sola-pinib to the National Medical Products Administration of China in the first half of 2026 for the treatment of warm antibody autoimmune hemolytic anemia [1] - Complete data from the ESLIM-02 study will be presented at an upcoming academic conference [1]

Core Viewpoint - Hutchison China MediTech Limited (和黄医药) has seen a stock increase of over 3%, currently trading at HKD 21.98, following the announcement of positive results from the ESLIM-02 study for its Syk inhibitor, selinexor, in treating warm antibody autoimmune hemolytic anemia in adults [1]. Group 1: Study Announcement - On January 7, Hutchison China MediTech announced that the ESLIM-02 study, a Phase III registration trial, has met its primary endpoint of durable hemoglobin response during the treatment period from week 5 to week 24 [1]. - The ESLIM-02 study is a randomized, double-blind, placebo-controlled clinical trial conducted in China, targeting adult patients with relapsed or refractory warm antibody autoimmune hemolytic anemia who have previously received at least one standard treatment [1]. - Results from the Phase II portion of the ESLIM-02 study were published in The Lancet Haematology in January 2025 [1]. Group 2: Future Plans - Hutchison China MediTech plans to submit a new drug application for selinexor to the National Medical Products Administration of China in the first half of 2026 for the treatment of warm antibody autoimmune hemolytic anemia [1]. - Complete data from the ESLIM-02 study will be presented at an upcoming academic conference [1].

Core Insights - The core viewpoint of the articles is that the Syk inhibitor, Solipnib, has shown promising results in the ESLIM-02 study for treating warm antibody autoimmune hemolytic anemia in adults, indicating a potential new treatment option for patients who have failed standard therapies [1][2]. Group 1: Study Results - The ESLIM-02 study has reached its primary endpoint of durable hemoglobin (Hb) response during the treatment period from week 5 to week 24 [1]. - In the II phase of the study, Solipnib demonstrated a significant overall response rate of 43.8% compared to 0% for the placebo in the first 8 weeks, and an overall response rate of 66.7% during the 24-week treatment period, including patients who crossed over from the placebo [1]. - The safety profile of Solipnib was reported to be good throughout the study [1]. Group 2: Expert Commentary - Professor Zhang Fengkui, a principal investigator of the ESLIM-02 study, highlighted the disease's heterogeneity and chronic relapsing nature, which severely impacts patients' quality of life and can be life-threatening if not effectively controlled [2]. - The positive topline results of the ESLIM-02 study underscore the potential of Solipnib to provide rapid and durable hemoglobin responses for patients with limited treatment options after standard therapy failure [2]. - The complete data from the ESLIM-02 study will be submitted for presentation at an upcoming academic conference [2]. Group 3: Future Plans - The company plans to submit a new drug application for Solipnib to the National Medical Products Administration of China in the first half of 2026 for the treatment of warm antibody autoimmune hemolytic anemia [2].

Core Viewpoint - Hutchison China MediTech Limited (00013.HK) announced that its Syk inhibitor, Solipnib, has achieved the primary endpoint of durable hemoglobin (Hb) response during the treatment period of weeks 5 to 24 in the Phase III registration study ESLIM-02 for adult patients with warm antibody autoimmune hemolytic anemia [1] Group 1 - The ESLIM-02 study is focused on the treatment of adult patients suffering from warm antibody autoimmune hemolytic anemia [1] - The primary endpoint achieved indicates a significant milestone in the development of Solipnib for this specific patient population [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完整性亦不發表任何聲明，並明確表示，概 不對因本公告全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 HUTCHMED (China) Limited 和黃醫藥（中國）有限公司 （於開曼群島註冊成立的有限公司） （股份代號：13） 自願性公告 和黃醫藥宣佈索樂匹尼布 (sovleplenib) 用於治療溫抗體型自身免疫性溶血性貧血的 ESLIM-02中國研究的III期階段取得陽性頂線結果 索樂匹尼布是一種新型、研究性的選擇性口服小分子Syk抑制劑 。Syk作為B細胞受體和Fc受體信號傳導通路中的 一個關鍵蛋白，是多種亞型的B細胞淋巴瘤及自身免疫疾病的成熟治療靶點。 攜帶免疫球蛋白Fc-gamma受體（FcγR）的巨噬細胞加速清除被抗體包裹的紅細胞被認為是溫抗體型自身免疫性 溶血性貧血的致病機制。6 被激活的Syk會介導吞噬細胞中活化的Fc受體的下游信號傳導，導致對紅細胞的吞噬作 用。7 此外，活化的Syk通過B細胞受體介導B淋巴細胞的激活並分化為能分泌抗體的漿細胞。8 抑制Syk可通過抑 制吞噬作用和減少 ...