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]

Group 1 - The majority of Hong Kong pharmaceutical stocks experienced an increase, with 恒瑞医药 (Hengrui Medicine) and 和黄医药 (Hutchison China MediTech) rising over 3% [1] - 康龙化成 (Crown Bioscience), 石药集团 (Shijiazhuang Pharmaceutical Group), and 泰凌医药 (Tianling Pharmaceutical) saw increases of over 2% [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 ...

Core Insights - HUTCHMED announced that the Phase III registration part of the ESLIM-02 clinical trial for sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) has met its primary endpoint of durable hemoglobin response rate within weeks 5 to 24 of treatment [1][3] Group 1: Clinical Trial Results - The ESLIM-02 study is a randomized, double-blind, placebo-controlled trial focusing on adult patients with primary or secondary wAIHA who have relapsed or are refractory to at least one prior line of standard treatment [2] - Results from the Phase II part of the study showed an overall response rate of 43.8% compared to 0% in the first 8 weeks, and 66.7% during the 24 weeks of treatment with sovleplenib, indicating a significant hemoglobin benefit [2][3] - The positive topline results suggest that sovleplenib could provide rapid and durable hemoglobin responses for patients with limited treatment options [3] Group 2: Drug Information - Sovleplenib is a novel, investigational selective small molecule inhibitor targeting spleen tyrosine kinase (Syk), which plays a crucial role in B-cell receptor and Fc receptor signaling [4] - The mechanism of action involves the inhibition of phagocytosis and reduction of antibody production, which may be beneficial in treating wAIHA [5] - In addition to wAIHA, sovleplenib is also being studied for immune thrombocytopenia (ITP), with positive results from a Phase III trial in China [6] Group 3: Future Plans - HUTCHMED plans to submit a New Drug Application (NDA) for sovleplenib for wAIHA to the China National Medical Products Administration (NMPA) in the first half of 2026 [3] - Full results of the ESLIM-02 study will be presented at an upcoming scientific conference, indicating ongoing commitment to transparency and scientific communication [3]

Investment Rating - The report does not explicitly state an investment rating for the biopharmaceutical industry or Fitinib specifically Core Insights - The biopharmaceutical innovation market in China is experiencing significant developments, particularly in the context of Fitinib, with a focus on market trends, sales dynamics, and competitive landscape [4][6][28] - The Hong Kong innovation drug sector has shown strong performance, with the Hang Seng Innovation Drug Index rising approximately 18% in July 2025, significantly outperforming the A-share market [6] - The A-share innovation drug sector is also on an upward trend, with notable advancements in tumor immunotherapy and neurodegenerative disease drugs [6] - Fitinib's sales volume and revenue have shown fluctuations, with a notable decline in July 2025, indicating market pressures and competitive challenges [7][14] Sales Dynamics - Fitinib's sales volume in China has been volatile, with 1mg and 5mg specifications experiencing fluctuations and overall growth stagnation or decline as of July 2025 [7][9] - In July 2025, the sales volume for 1mg was 13,053 boxes, down 7.9% from the previous month, while the 5mg specification saw a slight decline to 5,319 boxes [8][9] - Year-over-year sales trends from July 2020 to July 2025 show that 1mg sales increased by 156.0% in 2021 but have since plateaued, with a slight decline of 0.4% in 2025 [10][21] Revenue Dynamics - The sales revenue for Fitinib's 1mg and 5mg specifications also declined in July 2025, reflecting intense market competition and policy adjustments [14][16] - The 1mg specification's revenue was 2,461.0 million yuan in July 2025, down 7.9%, while the 5mg specification's revenue was 1,336.3 million yuan, down 0.7% [15][16] - Historical revenue data indicates that the 1mg specification had a consistent growth trend until 2025, where it experienced a decline, while the 5mg specification has shown a continuous downward trend since 2023 [17][21] Generic Drug Dynamics - As of July 2025, the first generic application for Fitinib by Zhengda Tianqing Pharmaceutical has been accepted, positioning the company to potentially capture market share as the original patent expires [22][27] - The core compound patent for Fitinib is expected to expire in May 2028, with additional patent challenges that may allow generics to enter the market sooner [27][22] New Drug Development Trends - The report highlights significant advancements in small molecule targeted therapies for colorectal cancer, with multiple companies making progress in new drug development [28][31] - Notable developments include FDA approvals for new combination therapies that provide additional treatment options for patients with specific mutations in colorectal cancer [28][31][35]

Major Events - Yunzhisheng (09678) secured a regional medical cooperation contract worth over 20 million [1] - Kelun-Biotech (06990) received breakthrough therapy designation from NMPA for TROP2 ADC drug in combination with pembrolizumab for treating PD-L1 positive locally advanced or metastatic non-small cell lung cancer [1] - InSilico Medicine (03696) entered into an 8.88 billion USD multi-year collaboration for anti-tumor drug development with Sihuiya [1] - Hutchison China MediTech (00013) is conducting a Phase III study on surufatinib combined with camrelizumab for first-line treatment of pancreatic ductal adenocarcinoma [1] - Ascletis Pharma-B (01672) announced FDA approval for IND of ASC30 in a 13-week Phase II study in diabetic patients [1] - Foryou Medical (01696) received quality standard inspection approval for its reauthorized injectable botulinum toxin from the Chinese National Medical Products Administration [1] - CanSino Biologics (06185) obtained clinical trial approval in China for its 24-valent pneumococcal polysaccharide conjugate vaccine [1] - Stone Group (02005) received drug production registration approval for perindopril and amlodipine tablets [1] - Sunny Optical Technology (02382) proposed to spin off its automotive optical business for independent listing on the Hong Kong Stock Exchange [1] - Dongyang Sunshine Pharmaceutical (06887) completed the first patient enrollment for HECN30227 in China [1] - Haitong International's subsidiary plans to sell 100% equity of Guohua Machinery for 342 million [1] - Yuexiu Property (00123) subsidiary intends to sell 73.74% actual equity in Hangzhou Yueyun [1] - CIMC Group (02039) subsidiary CIMC Shilianda plans to introduce strategic investors through capital increase and transfer of a small number of old shares [1] Operating Performance - Chifeng Jilong Gold Mining (06693) expects annual net profit attributable to shareholders to be approximately 3 billion to 3.2 billion, an increase of about 70% to 81% year-on-year [2] - Corning Hospital (02120) anticipates outpatient visits to reach approximately 720,200 in 2025, a year-on-year increase of 29% [2] - Seres (09927) reported total vehicle sales of 63,700 units in December, a year-on-year increase of 53.54% [2] - Xiehe New Energy (00182) reported an equity power generation of 790.32 GWh in December [2] - Country Garden (02007) reported contract sales amounting to approximately 2.69 billion attributable to shareholders in December [2]