Core Viewpoint - China National Pharmaceutical Group's innovative drug Bemosituzumab (brand name: Andevate®) has received approval from the National Medical Products Administration (NMPA) for a new indication in treating unresectable stage III non-small cell lung cancer (NSCLC) patients who have not experienced disease progression after platinum-based chemoradiotherapy [1] Group 1 - The approval is based on positive results from the R-ALPS study, which was presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [1] - The study included patients with locally advanced or unresectable stage III NSCLC who received either Bemosituzumab or a placebo as consolidation treatment until disease progression, with the primary endpoint being progression-free survival (PFS) assessed by blinded independent central review (BICR) [1] Group 2 - The median follow-up time was 19.4 months, with a median PFS of 9.69 months for the Bemosituzumab group compared to 4.17 months for the placebo group (HR=0.53, 95% CI 0.39-0.72, p<0.0001), indicating a 47% reduction in the risk of disease progression or death [2] - Subgroup analyses showed consistent benefit trends across various groups, demonstrating the broad applicability of this treatment [2] - Overall survival (OS) data is not yet mature, with median OS not reached, but a trend towards OS benefit was observed (HR=0.76, 95% CI 0.50-1.14) [2] Group 3 - The incidence of grade 3 or higher treatment-related adverse events (TRAEs) was 29.4% in the Bemosituzumab group compared to 19.7% in the placebo group [2] - Bemosituzumab is the third PD-L1 inhibitor approved in China for consolidation treatment after radical chemoradiotherapy for locally advanced or unresectable NSCLC [2] - The company aims to continue focusing on innovation in lung cancer treatment, developing a pipeline that covers multiple molecular subtypes and treatment scenarios to enhance patient survival benefits [2]

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份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之有限公司） 網站：www.sinobiopharm.com （股份編號：1177） 自願公告 • 中位隨訪時間19.4個月，貝莫蘇拜單抗組中位PFS為9.69個月，安慰劑組為4.17個月（HR=0.53， 95% CI 0.39-0.72， p<0.0001 ），患者疾病進展或死亡風險降低47%； • 預設的亞組分析（是否吸煙、前序治療方式為同步╱序貫）結果顯示，各亞組與意向性治療(ITT) 人群獲益趨勢一致，展現出該治療方案的廣泛適用性； 貝莫蘇拜單抗注射液非小細胞肺癌放化療後維持適應症獲批上市 中國生物製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」）宣佈，本集團自 主研發的國家1類創新藥貝莫蘇拜單抗（商品名：安得衛® ）新適應症已獲得中國國家藥品監督管理局 (NMPA)的上市批准，用於在接受鉑類藥物為基礎的同步或序貫放化療後未出現疾病進展的未攜帶已 ...

在成立第11个年头，他们交出了第一份答卷——一款"从头到 尾"中国原创的新药。和路径清晰的仿制药、跟随式创新药物 不同，这种从发现病毒感染机制、作用靶点到药物研发的完全 创新，在中国制药史上是罕有的。 作者：张铃 封图：华辉安健官网 2026年1月23日，深夜11点，李文辉和隋建华走进一家西北餐厅，两碗炒面，是这对科学家夫妻 的晚餐，也是他们的庆功宴。 李文辉是病毒学家，隋建华是抗体工程专家，他们同为北京生命科学研究所（下称"北生所"）研 究员、华辉安健联合创始人。吃这顿特别晚餐那天，是他们最重要作品诞生的日子。经过十余年共 同研究，全球病毒性肝炎领域第一款单抗药物立贝韦塔单抗注射液（下称"立贝韦塔"）获批上 市。 下午5点半，国家药监局披露立贝韦塔获批的消息，这之后，夫妻俩做的第一件事就是挨个回复国 内外传来的祝贺，直到深夜。李文辉是兰州人，他原本想带隋建华吃碗牛肉拉面，但赶到餐厅时， 最后一锅汤已经被收起来了。第二天，他们没有像往常周末那样早早出门工作，而是继续在家给一 路上支持过立贝韦塔的同道们发感谢信，那是他们罕见的"偷懒"时刻。 "感谢了那么多人，其实，我最想感谢的是这个时代。"隋建华说。 隋建华回 ...

经济观察网 安科生物（300009）近期在药品集采及创新药研发方面取得多项进展。 抗感染药物AK1012项目（干扰素α2b吸入溶液）正在开展II/III期临床试验。 参股公司博生吉安科的PA3-17注射液（CD7-CAR-T疗法）被纳入突破性治疗品种，处于关键II期临床； 元宋生物的"重组L-IFN腺病毒注射液"推进至IIa期。 与阿法纳合作的AFN0328注射液（治疗HPV相关病变）完成I期临床，属首创药物。 战略推进 股票近期走势 国家集采接续采购中选：2026年2月11日，公司公告其阿托西班注射剂（适用于推迟早产）和丙酚替诺 福韦口服常释剂型（适用于慢性乙型肝炎）拟中选国家组织药品集采协议期满品种接续采购。采购周期 计划至2028年12月31日，若后续合同落地，可能对销售量及市场占有率产生积极影响。 产品研发进展 在研产品临床试验推进：根据2026年2月6日公司披露，多项创新药研发取得进展： HER2靶点药物如HuA21注射液（已完成Ib/II期入组，计划III期）、AK2024注射液（I期临床）和HK010 双抗（II期首例入组）正处于关键阶段。 生长激素领域，AK2017注射液（重组人生长激素-Fc ...

经济观察报 记者 张铃 2026年1月23日，深夜11点，李文辉和隋建华走进一家西北餐厅，两碗炒面，是这对科学家夫妻的晚餐，也是他们的庆功宴。 李文辉是病毒学家，隋建华是抗体工程专家，他们同为北京生命科学研究所（下称"北生所"）研究员、华辉安健联合创始人。吃这顿特别晚餐那天，是他们 最重要作品诞生的日子。经过十余年共同研究，全球病毒性肝炎领域第一款单抗药物立贝韦塔单抗注射液（下称"立贝韦塔"）获批上市。 下午5点半，国家药监局披露立贝韦塔获批的消息，这之后，夫妻俩做的第一件事就是挨个回复国内外传来的祝贺，直到深夜。李文辉是兰州人，他原本想 带隋建华吃碗牛肉拉面，但赶到餐厅时，最后一锅汤已经被收起来了。第二天，他们没有像往常周末那样早早出门工作，而是继续在家给一路上支持过立贝 韦塔的同道们发感谢信，那是他们罕见的"偷懒"时刻。 "感谢了那么多人，其实，我最想感谢的是这个时代。"隋建华说。 在他们创立华辉安健的2015年，中国政府启动药审改革，此后10年，中国创新药开启了新时代，逐渐与世界接轨。在产业政策扶持及各方资本支持下，华辉 安健从一家只有几名员工、一个临床前分子的初创企业，成长为一家有上百名员工、多个推进 ...

Regulatory Situation - In January 2026, the company was fined a total of 3.125 million yuan by the Shandong Provincial Drug Administration for producing and selling substandard sodium bicarbonate injection, following a penalty decision made in November 2025 [2] Performance and Operating Conditions - For the first three quarters of 2025, the company reported revenue of 2.584 billion yuan, a year-on-year decrease of 13.94%, and a net profit attributable to shareholders of 382 million yuan, down 4.05% year-on-year. In the third quarter alone, net profit increased by 19.61% year-on-year, although the non-recurring net profit declined, indicating fluctuations in profit quality. The company's debt ratio stands at 18.72%, with a gross margin of 55.08% [3] Product Development Progress - The company has multiple innovative drug pipelines in clinical phase II, including WX-081 tablets and WX390 tablets. Additionally, a flu treatment drug, WXSH0208 tablets, has received approval for clinical trials. The subsidiary, Chenshin Fudu Pharmaceutical, has expanded its coverage for oral liquid products under medical insurance, although specific launch dates have not been announced [4] Capital Movements - As of February 6, 2026, the company experienced a weekly net inflow of 12.4296 million yuan in principal funds, with significant daily fluctuations. On February 6, the net inflow reached 20.6828 million yuan. The stock price has been fluctuating around the 17-18 yuan range, with technical indicators showing dispersed holdings and market sentiment influenced by the overall industry [5] Future Development - The company's subsidiary, Shandong Chenshin Fudu Pharmaceutical, has plans to list on the Beijing Stock Exchange, which were approved in 2024, but further progress will depend on official announcements. The pharmaceutical sector is affected by centralized procurement policies and trends in innovative drug development, requiring the company to balance regulatory risks with growth opportunities [6]

Core Insights - Recent developments for BeiGene include the approval of a supplemental application for the subcutaneous formulation of Tislelizumab for malignant tumor treatment, which is expected to enhance patient compliance and market potential [1] - The company plans to release its financial results for Q4 and the full year of 2025 on February 26, 2026, which will be followed by a board meeting and a conference call for investors [1] Stock Performance - BeiGene's stock has shown volatility recently, with A-shares closing at 279.62 CNY, down 1.09% on February 13, 2026, but up 2.61% over the past five days; Hong Kong shares closed at 208.60 HKD, down 0.48%, with a 1.66% increase over five days; and US shares at 350.12 USD, up 1.07% on the same day but down 1.07% over five days [2] - On February 12, 2026, A-share main funds experienced a net outflow of 18.68 million CNY, with a trading volume of 311 million CNY, indicating some profit-taking pressure amid market sentiment [2] Financial Analysis - Preliminary data shows that for the first nine months of 2025, BeiGene reported revenue of 27.595 billion CNY, a year-on-year increase of 44.21%, and a net profit attributable to shareholders of 1.139 billion CNY, up 130.88% [3] - The significant growth in performance is primarily driven by the sales expansion of core products like Tislelizumab, and investors should pay attention to the company's profitability and globalization progress in the upcoming financial report [3]

Company Overview - The stock price of Ascentage Pharma has shown volatility despite positive developments in research and development, with the stock performance not meeting expectations [1] - The company's new generation BTK degrader APG-3288 received clinical approval from the National Medical Products Administration of China on February 6, 2026, and initiated a global multi-center Phase I clinical trial for relapsed/refractory hematologic malignancies on February 11, 2026 [1] - As of February 13, the closing price of the stock was HKD 47.50, with a daily increase of 2.41%, but a year-to-date decline of 9.09% [1] Industry Context - The innovative drug sector is currently facing valuation adjustment pressure, with the market showing impatience towards the long-term commercialization of unprofitable biotech companies, focusing more on short-term profitability [1] - The Hong Kong biotechnology sector declined by 0.95%, while the Hang Seng Index fell by 1.72%, indicating that the sector underperformed the broader market, further intensifying individual stock pressures [1] Financial Performance - The core product, Nairik, saw sales revenue increase by 93% year-on-year to CNY 217 million in the first half of 2025, with another product, Lishengtuo, approved for market launch in July 2025 [2] - However, the net loss expanded to CNY 591 million during the same period, primarily due to reduced intellectual property licensing income and increased R&D expenditures [2] - Market focus is on key catalysts, such as overseas indication approvals, which are concentrated post-2027, leading to a lack of patience for long-term narratives and a greater emphasis on short-term performance [2] Market Sentiment - On February 12, there was a net outflow of HKD 4.926 million from major funds in the Hong Kong stock market, and a net outflow of HKD 11.534 million from retail investors, indicating strong short-term risk-averse sentiment [2] - Although there was a net inflow of HKD 1.4948 million on February 13, major funds still experienced a net outflow of HKD 193,900, reflecting cautious institutional attitudes [2] - Technical indicators show that while the MACD histogram has turned positive, the KDJ is in the oversold zone, suggesting weak short-term momentum [2] Future Outlook - The R&D progress of Ascentage Pharma provides long-term value support, but it has not fully offset industry adjustments, risk aversion in funding, and market concerns regarding profitability in the short term [2] - The stock's volatility reflects the market's balancing act between technological innovation and short-term performance [2]

本周，中证港股通医药卫生综合指数上涨3.3%，恒生港股通创新药指数上涨2.5%，中证创新药产业指数、沪深300医 药卫生指数均下跌0.2%，中证生物科技主题指数下跌0.6%。 华创证券称，医药行业能在持续经历各种挑战后走向新高最本质的原因，是人类对医药行业的持续需求和越来越多的 未被满足的需求，以及药企不断持续加大研发投入去满足这些需求。中国如今已成为全球创新药研发的重要参与者，海外 授权热度持续连年攀升，医药行业进入"创新驱动"的营收时代。 | | 恒生港股通 | 中证港股通 | 中证创新 | 中证生物 | 沪深300 | | --- | --- | --- | --- | --- | --- | | | 创新药指数 | 医药卫生综 | 药产业指 | 科技主题 | 矢药卫生 | | | | 合指数 | " | 指数 | 指数 | | 本周涨跌幅 | 2.5% | 3.3% | -0. 2% | -0. 6% | -0. 2% | | 指数估值 | 滚动市盈率 55.6倍 | 滚动市盈率 33. 4倍 | 滚动市盈率 51.3倍 | 滚动市盈率 54. 1倍 | 滚动市盈率 29.8倍 | | 指数估值 | ...

Group 1 - The core viewpoint of the news is that Jiuyuan Gene has received acceptance for its clinical trial application for the innovative drug JY54 injection, aimed at weight management in Phase I studies [1] - JY54 injection is a next-generation weight loss therapy that operates through a mechanism similar to insulin, providing multiple metabolic regulation effects [1] - The product is positioned to complement existing GLP-1 products, highlighting the company's strategic extension in the field of metabolic diseases [1] Group 2 - In the recent stock performance, Jiuyuan Gene's share price experienced a fluctuation, reaching a high of 10.35 HKD on February 10 and a low of 9.40 HKD on February 13, with a total decline of 4.39% over the period [2] - Following the announcement, there was a significant increase in trading volume on February 10, with a turnover of 572.71 million HKD, but subsequent trading days saw a decrease in volume [2] - The company repurchased 26,000 shares at a cost of 255,300 HKD on February 12, indicating limited scale in its buyback activity [2]