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 ...

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]

Core Insights - The Chinese innovative pharmaceutical industry is undergoing a historic transformation, shifting from "fast followers" to "originators" in drug development, supported by solid data and market performance [1] - By 2025, the total value of innovative drug licensing transactions in China is expected to exceed $130 billion, with over 150 transactions, marking a historical high [1] - Shanghai's Pudong district is becoming a key hub for the global market, with significant achievements in CAR-T products and first-class new drugs [1] Industry Performance - China's pharmaceutical industry ranks second globally, with approximately 30% of innovative drugs in development worldwide [1] - Pudong has approved 4 CAR-T products, accounting for 30% of the global total, and 7 first-class new drugs, representing 14% of the national total [1] - Business development (BD) transaction amounts in Pudong reached $20.4 billion, making up 14% of the global total [1] Competitive Advantages - Chinese innovative drug companies are gaining a competitive edge in the global market due to their speed and cost-effectiveness, being able to advance drug discovery 2-3 times faster and recruit clinical trial patients at half the cost compared to Western counterparts [2] - Companies like Maiwei Biotech and Jinsai Pharmaceutical are establishing significant overseas BD collaborations, enhancing China's global competitiveness in innovative drugs [2] Strategic Collaborations - Maiwei Biotech has accelerated its BD efforts, forming exclusive licensing agreements for innovative therapies, including a collaboration with Calico Life Sciences for an IL-11 targeted therapy [2][3] - Jinsai Pharmaceutical's subsidiary has signed an exclusive licensing agreement with Yarrow Bioscience for a monoclonal antibody, with potential milestone payments totaling up to $1.365 billion [4] Full-Chain Development - A number of innovative drug companies are building comprehensive overseas strategies that cover research, registration, and sales, transitioning from "licensing out" to "commercialization abroad" [5] - By 2024, Pudong is expected to have over 20 innovative drugs achieving commercial sales, with total sales exceeding 11.6 billion yuan [5] Global Market Positioning - Junshi Bioscience's innovative drug has become a benchmark for commercialization abroad, having been approved in over 40 countries and regions [5][6] - The core challenge for Chinese companies in international markets is to ensure their products meet local medical needs, requiring innovation, efficacy, and safety [5] Talent and Ecosystem - The rise of China's innovative drug industry is supported by years of policy guidance, technological accumulation, and capital cultivation, with a strong emphasis on the importance of a mature industrial ecosystem [12] - Pudong's unique industrial atmosphere, talent pool, and complete industrial chain are critical advantages for local companies [12][13] Future Outlook - The Pudong district plans to enhance its support for the life sciences industry, aiming to become a global hub for innovative drugs and medical devices by 2025 [15] - The industry anticipates that internationalization will remain a core development trend for domestic biopharmaceutical companies over the next 3-5 years [7][8]

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]

Core Insights - Asia's equity capital markets are projected to have a strong performance in 2026, continuing the momentum from 2025, which saw significant growth in share sales across the region [1][2] Group 1: Market Performance - In 2025, share listings, placements, and block trades in Asia Pacific raised $262.7 billion, marking the highest total in four years [2] - For the first time, four of the world's five busiest deal venues were located in Asia, driven by a rebound in Hong Kong and record IPOs in India [2] Group 2: Upcoming IPOs - Major IPOs expected in 2026 include Baidu Inc., Zepto Ltd., ChangXin Memory Technologies Inc., and Coca-Cola's India bottling unit [3] - Hong Kong listings of Chinese firms already traded in mainland China are anticipated to continue contributing to the IPO pipeline [3] Group 3: Regional Highlights - Hong Kong listings may raise up to $45 billion in 2026, potentially the largest amount in six years, while Indian IPOs are expected to achieve a third consecutive annual record [4] - Jio Platforms Ltd. is preparing for what could be India's largest-ever IPO, while A.S. Watson Group is considering a listing that could raise over $2 billion [8] Group 4: Notable Companies and Their Plans - Syngenta Group is in preliminary talks for a potential listing in 2026 after previously withdrawing a $9 billion plan [8] - Baidu's AI chip unit has confidentially filed for a Hong Kong IPO, valued at a minimum of $3 billion [8] - Other companies like Luxshare Precision Industry Co. and Muyuan Foods Co. are also pursuing significant IPOs in Hong Kong [8] Group 5: Indian Market Developments - PhonePe Ltd. has filed for an IPO that could raise up to $1.5 billion, valuing the fintech firm at approximately $15 billion [13] - Flipkart is exploring an IPO after moving its holding company to India, while Zepto aims to raise about $500 million through its IPO [13] Group 6: International Listings - SK Hynix Inc. is considering a potential New York listing to align its valuation with global peers [13] - Shein Group Ltd. has confidentially filed for a Hong Kong IPO, pending approval from Beijing [13]

Core Viewpoint - The company, Hutchison China MediTech Limited (和黄医药), has initiated the Phase III portion of a clinical trial for surufatinib in combination with camrelizumab, nab-paclitaxel, and gemcitabine for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) patients in China, with the first patient receiving treatment on December 30, 2025 [1]. Group 1 - The study is a multicenter, randomized, open-label, positive-controlled Phase II/III clinical trial aimed at evaluating the efficacy and safety of the S+C+AG regimen compared to the AG regimen in adult patients with metastatic pancreatic cancer who have not previously received systemic anti-tumor therapy [2]. - The Phase II portion of the study included 62 patients, with plans to enroll approximately 400 additional patients in the Phase III portion [2]. - The primary endpoint of the Phase III portion is overall survival (OS), while secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), quality of life, and safety [2]. Group 2 - Results from the Phase II portion were recently presented at the 2025 European Society for Medical Oncology (ESMO) Asia Congress, showing a median PFS of 8.15 months as of the data cutoff on July 24, 2025 [3]. - The S+C+AG group had a median PFS of 7.20 months compared to 5.52 months for the AG group, indicating a 50.1% reduction in the risk of disease progression or death (HR 0.499, p=0.0407) [3]. - Other key efficacy endpoints showed similar benefits, with an ORR of 67.7% versus 41.9% (p=0.0430) and a DCR of 93.5% versus 71.0% (p=0.0149) [3]. - Although overall survival data is not yet mature, a positive trend has been observed, with 9 events in the S+C+AG group and 15 events in the AG group [3]. - The treatment demonstrated manageable safety characteristics, with 80.6% of patients in the S+C+AG group experiencing grade 3 or higher treatment-emergent adverse events (TEAEs), compared to 61.3% in the AG group [3].

Core Viewpoint - The company announced the initiation of a Phase III portion of a clinical trial for surufatinib in combination with camrelizumab, nab-paclitaxel, and gemcitabine for first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) patients in China, with the first patient receiving treatment on December 30, 2025 [1] Group 1: Clinical Trial Details - The study is a multicenter, randomized, open-label, positive-controlled Phase II/III clinical trial aimed at evaluating the efficacy and safety of the S+C+AG regimen compared to the AG regimen in adult metastatic pancreatic cancer patients who have not previously received systemic anti-tumor treatment [2] - The Phase II portion included 62 patients, with plans to enroll approximately 400 additional patients in the Phase III portion [2] - The primary endpoint for the Phase III portion is overall survival (OS), while secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), quality of life, and safety [2] Group 2: Phase II Results - The results of the Phase II portion were recently presented at the 2025 ESMO Asia Congress, with a median PFS follow-up time of 8.15 months [3] - The median PFS for the S+C+AG group was 7.20 months, compared to 5.52 months for the AG group, indicating a 50.1% reduction in the risk of disease progression or death (stratified hazard ratio [HR] 0.499, log-rank test p=0.0407) [3] - Other key efficacy endpoints showed similar benefits, including ORR (67.7% vs. 41.9%, p=0.0430) and DCR (93.5% vs. 71.0%, p=0.0149) [3] - Although overall survival data is not yet mature, a positive trend has been observed, with 9 events in the S+C+AG group (N=31) and 15 events in the AG group (N=31) [3] - The treatment demonstrated manageable safety characteristics, with 80.6% of patients in the S+C+AG group experiencing grade 3 or higher treatment-emergent adverse events (TEAEs), compared to 61.3% in the AG group [3]

Core Viewpoint - Hutchison China MediTech Limited (HCM) has announced the initiation of a Phase III portion of a clinical study for surufatinib in combination with camrelizumab, nab-paclitaxel, and gemcitabine for first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) patients in China, with the first patient receiving treatment on December 30, 2025 [1] Group 1 - The clinical study is a Phase II/III trial focusing on the treatment of metastatic PDAC [1] - The combination therapy includes surufatinib, camrelizumab, nab-paclitaxel, and gemcitabine [1] - The first patient has already commenced treatment as of December 30, 2025 [1]

HUTCHMED (China) Limited 和黃醫藥（中國）有限公司 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。 （於開曼群島註冊成立的有限公司） （股份代號：13） 自願性公告 和黃醫藥啟動現正進行中的索凡替尼聯合卡瑞利珠單抗用於治療 初治胰腺導管腺癌研究的III期階段 和黃醫藥（中國）有限公司（簡稱「和黃醫藥」或 「HUTCHMED」）今日宣佈啟動索凡替尼（surufatinib）聯合 卡瑞利珠單抗（camrelizumab）、白蛋白結合型紫杉醇（nab-paclitaxel）和吉西他濱（gemcitabine）用於一線 治療轉移性胰腺導管腺癌（PDAC）患者的中國II/III期研究的III期部分。首名患者已於2025年12月30日接受首次 給藥治療。 胰腺導管腺癌是一種高度侵襲性的癌症，佔胰腺癌病例的90%以上。全球估計有511,000人被診斷為患有胰腺癌， 於2022年導致約467,000人死亡，平均的五年存活率低於10% 。在中國， ...