Core Insights - The ASCO conference has witnessed the rise of Chinese innovative drugs, with a significant increase in the number of oral presentations and Late-Breaking Abstracts from Chinese researchers over the past decade [1][2][4] - Chinese biopharmaceutical companies are now recognized for their quality research, with many studies presenting groundbreaking results that have global implications [4][5] - The "ASCO effect" has begun to influence stock prices of Chinese pharmaceutical companies, reflecting the growing importance of their research in the global market [5][6] Company Highlights - China Biologic Products set a record with 12 oral presentations at ASCO 2025, including 4 Late-Breaking Abstracts, totaling over 40 studies presented [4] - Innovative studies such as the DIAMOND trial by Junshi Biosciences have demonstrated significant advancements in treatment protocols, marking a shift from merely participating to leading in global research [4] - Companies like Innovent Biologics and Hengrui Medicine are at the forefront of ADC and bispecific antibody development, with numerous studies presented at ASCO [8][12] Industry Trends - The ADC sector is dominated by Chinese companies, with 89 out of 184 ADC-related studies presented at ASCO coming from China, representing approximately 48.4% of the total [8][10] - The bispecific antibody (bispecific) pipeline from China accounts for nearly 50% of the global total, with significant clinical advancements reported at ASCO [12][14] - The trend of increasing license-out transactions and upfront payments for Chinese innovative drugs indicates a shift in the global pharmaceutical landscape, with a notable rise in the use of the NewCo model for collaborations [18][24] Market Impact - The stock prices of companies like China Biologic Products and Innovent Biologics have seen significant increases following the ASCO conference, indicating a positive market response to their research presentations [6] - The total value of license-out transactions for Chinese pharmaceutical companies has surged, with a notable increase in upfront payments, reflecting enhanced negotiation power [20][24] - The emergence of new treatment modalities and innovative drug pipelines positions Chinese companies as key players in the global biopharmaceutical market [16][18]

Core Insights - The National Medical Products Administration approved 11 innovative drugs recently, with 10 coming from listed companies, indicating a significant advancement in China's pharmaceutical sector [1][4] - The approval of these drugs marks a pivotal moment for the industry, as it transitions into a phase of realizing the results of extensive research and development efforts [7][8] Group 1: Drug Approvals and Innovations - Among the approved drugs, several are the first of their kind in China, including Bai Jie Shen Zhou's injection of Zhenida Monoclonal Antibody, which is the first HER2 dual-target drug approved for cholangiocarcinoma [4][5] - Heng Rui Pharmaceutical's Apixaban is a multi-target tyrosine kinase inhibitor approved for use in advanced solid tumors, showcasing innovative treatment mechanisms [4][5] - The approval of Zai Jing Pharmaceutical's Jikaxitinib marks the first domestic JAK inhibitor for treating myelofibrosis, providing new options for patients with rare blood cancers [5][6] Group 2: Market Trends and Investment Opportunities - The innovative drug sector has seen a strong market performance, with 53 stocks hitting the daily limit up, indicating heightened investor interest [2][7] - Analysts predict that 2025 will be a transformative year for the pharmaceutical industry, characterized by increased revenue, profitability, and valuation improvements [1][7] - The Hong Kong innovation drug index has seen significant capital inflow, with over 200 million yuan in net inflow over the past 20 trading days, reflecting strong market sentiment [2][8] Group 3: Challenges and Future Outlook - Despite the positive developments, the innovative drug industry faces challenges such as high uncertainty in commercialization and intense competition among similar products [7][8] - The industry is supported by favorable policies and the growth of commercial health insurance, which enhances the payment environment for innovative drugs [8]

Core Insights - Baiyue Shenzhou's bispecific HER2 inhibitor, Zhenidamab (百赫安), received conditional approval from the National Medical Products Administration (NMPA) for treating HER2-positive advanced or metastatic biliary tract cancer (BTC) patients who have previously undergone systemic therapy [1][2] - This approval marks Zhenidamab as the first and only bispecific antibody approved in China for targeted therapy of HER2-positive biliary cancer, providing a new treatment option for patients [1][2] - The incidence of biliary tract cancer is on the rise, with approximately 15% to 30% of BTC patients exhibiting HER2 abnormalities, making HER2 a key target for BTC treatment [1] Clinical Data - The conditional approval is based on the results of the global multicenter clinical study HERIZON-BTC-01, which showed an objective response rate (ORR) of 51.6% in previously treated, unresectable HER2-positive advanced or metastatic BTC patients [2] - The median duration of response (mDoR) was 14.9 months, and the median overall survival (mOS) was 18.1 months, indicating a significant improvement in survival compared to previous second-line chemotherapy options [2] - The safety profile of Zhenidamab was reported to be favorable, demonstrating good overall safety [2] Mechanism of Action - Zhenidamab utilizes a dual-targeting mechanism by binding to two different non-overlapping epitopes of the HER2 protein, enhancing its binding and inhibitory capabilities, which may lead to a synergistic effect in tumor suppression [2] - This innovative mechanism allows for dual signal blockade and the formation of larger receptor clusters, potentially improving therapeutic efficacy [2] Strategic Collaboration - Zhenidamab was developed by Zymeworks, with Baiyue Shenzhou entering a strategic partnership for its development and commercialization in Asia (excluding Japan), Australia, and New Zealand [3] - The drug is also set to be available in the United States, having received FDA approval for the same indication in November 2024 [3] - The President and COO of Baiyue Shenzhou expressed confidence that this innovative drug will significantly benefit the survival of BTC patients in China [3]

作者 | 哥吉拉 数据支持 | 勾股大数 据（www.gogudata.com） 5月29日，A股主要指数高开高走，截至收盘，沪指涨0.7%报3363点，深证成指涨1.24%，创业板指涨1.37%。全市场近4500股上涨，逾百 股涨停。 板块方面，金融科技、创新药、互联网、半导体等热门板块表现强势，市场情绪相比近日明显提振。 其中，创新药是涨幅最明显的板块之一，睿智医药、舒泰神、益方生物强势斩获20CM涨停，另有十多家医药股涨幅均超过10%，堪称又一轮 暴涨潮。 | 代码 | 名称 | 现价 | 1 9 mm a lond a rither more an a many 143 1994 (310 1 涨跌幅▼ | 年初至今涨跌幅 | 总市值1 | | --- | --- | --- | --- | --- | --- | | 300149 | 睿智医药 | 8.56 c | 20.06% | 33.33% | 43亿 | | 300204 | 舒泰神 | 23.04 c | 20.00% | 210.93% | 110亿 | | 688382 | 益元生物-U | 29.10 c | 20.00% | 11 ...

作者 | 黄绎达 编辑 | 郑怀舟 在A股市场，鲜有连续熊市超过三年的行业板块，而医药板块是其中的典型。从2021年7月到去年924行情启动之前，该板块经历了连续3年的下行调整， 申万医药生物指数在此期间的跌幅高达54%，板块市值近乎腰斩，众多医药龙头股亦同步陷入估值与业绩的双重回调。 在医药板块持续低迷的周期中，曾经风光无两的医药主题基金（以下简称：医药基金）也褪去了往日的光彩。根据wind统计，受医药板块长期熊市的拖 累，即便有去年924行情的提振，今年医药板块有所反弹，目前存续的600余只医药基金中，截至今年5月28日，大约2/3的基金净值目前还在1以下，最低 者甚至只有0.35。 但是从短期来看，进入2025年后，半数以上的医药基金在今年（截至5月28日）取得了正收益，表现优异者如长城医药产业精选、永赢医药创新智选、华 安医药生物、中银大健康等基金的同期收益在47%~56%区间，同类基金同期排名亦均位于前列，似乎医药基金的春天回来了。 那么，驱动医药基金在今年回暖的核心因素都有哪些？医药基金现在还能买吗？ 01 医药大盘反弹在beta层面支撑医药基金走强 医药基金近年来长期表现相对颓势，在不发生风格漂 ...

Core Insights - The approval of multiple BTK inhibitors in China is transforming the treatment landscape for Chronic Lymphocytic Leukemia (CLL) and B-cell lymphomas, with a notable shift towards second-generation BTK inhibitors [1][3][4] Group 1: Market Overview - As of now, five BTK inhibitors have been approved in China, including three imported drugs and two domestic drugs, with the first-generation inhibitor ibrutinib and three second-generation inhibitors [3] - The global incidence of CLL is significant, with 191,000 new cases and 61,000 deaths annually, primarily affecting elderly patients with a median age of 65 in China [2] Group 2: Treatment Efficacy and Safety - The five-year survival rate for CLL patients is high, ranging from 80% to 90%, with low-risk patients having a median survival of nearly 20 years [2] - Newer BTK inhibitors demonstrate improved safety profiles compared to first-generation inhibitors, which have seen a decline in global recommendation levels due to safety concerns [3][4] Group 3: Future Directions - The development of BCL2 inhibitors is underway, with ongoing clinical trials combining these with BTK inhibitors, indicating a potential new direction for CLL treatment [5] - The increasing elderly population in China presents challenges for long-term management of CLL patients, necessitating systematic approaches to address treatment adherence and adverse effects [5]

BEONE MEDICINES LTD. 百濟神州有限公司 提名及企業管治委員會章程 I. 一般成立目標聲明 A. 成員 提名委員會應每年審閱及重新評估本章程的恰當性，並將任何建議變動 提交董事會批准。 提名委員會應定期就企業管治的法律及實務的重大發展向董事會提供意 見，並在提名委員會認為適當的情況下就企業管治事宜向董事會提出建 議。提名委員會應制定企業管治框架，並向董事會提出建議並就此進行 監督，包括定期審查和重新評估本公司的章程、組織法規、企業管治 指引和行為守則的充分性，該等文件應滿足納斯達克股票市場規則第 B. 董事會和委員會的年度績效評估 提名委員會應每年評估其績效並將向董事會報告評估結果。 C. 挑選新董事 根據納斯達克股票市場規則第5605(e)(1)(B)條，本公司的提名委員會將 會完全由符合納斯達克股票市場規則第5605(e)(1)(B)條的獨立性測試的 董事組成。提名委員會成員的董事人數由董事會不時決定，但至少由兩 名董事組成。董事會應指定提名委員會的一名成員擔任提名委員會主席。 B. 免職和替換 提名委員會的成員應每年由董事會任命，並可在提出因由或並無提出因 由的情況下隨時由董事會決定替 ...

BEONE MEDICINES LTD. 百濟神州有限公司 薪酬委員會章程 I. 一般成立目標聲明 百濟神州有限公司（「本公司」）董事會（「董事會」）薪酬委員會（「薪酬委員 會」）的成立目標是(1)通過設計、審查和監督本公司高級管理人員薪酬計劃、政策 和規劃，履行與本公司董事（「董事」）及高級管理人員的薪酬有關的董事會職責， (2)監督本公司的整體薪酬結構、政策、以及與人才管理和繼任計劃有關的規劃， 以及(3)負責根據適用規則及規例編製一份報告供納入本公司有關其股東週年大會 的代理聲明或10-K表的年度報告。 薪酬委員會的主要目標是制定及實施薪酬政策與計劃，確保吸引並留住主要 管理人員，動員管理層實現本公司的企業目標及策略，以及把管理層的利益與本 公司股東的長期利益掛鈎。 A. 成員 薪酬委員會成員由股東在每次股東週年大會上選舉產生，任期根據董事 會的建議至下一屆股東週年大會，董事會應根據提名及企業管治委員會 的建議向股東提交該議案。 由董事會提議在薪酬委員會任職的人數應由董事會不時確定，但應由不 少於兩名成員組成，每名成員應滿足根據納斯達克股票市場規則5605(d) 訂立的獨立性標準，但受納斯達克股票市場規 ...

BEONE MEDICINES LTD. 百濟神州有限公司 科學諮詢委員會章程 I. 一般成立目標聲明 百濟神州有限公司「本公司」）董事會（「董事會」）轄下科學諮詢委員會（「委員 會」）的成立目的為協助董事會監督本公司的研發活動，並就戰略層面應考慮 的科學因素向董事會提供建議。 II. 組成 A. 成員 委員會的成員人數由董事會不時釐定，惟不得少於兩名。董事會可委任 委員會成員，其任期由董事會不時釐定。於確定董事是否合資格擔任委 員會成員時，董事會或會考慮董事的科學、臨床開發、監管、醫療及技 術專長，以及任何其他相關運營或業務經驗。 在董事會提名及企業管治委員會的指示下，委員會須定期評估自身表現。 B. 主席 董事會可酌情委任委員會主席。 C. 成員的免職、替換和辭職 董事會可在提出因由或並無提出因由的情況下隨時將任何委員會成員免 職或替換。無論出於何種理由，董事辭去董事會職務或董事被免職，將 自動構成委員會的辭任或免職（如適用）事宜。無論出於何種理由，委員 會的職位空缺可由董事會填補。 1 III. 會議 委員會可在其認為適當的時間及地點舉行會議，會議可以親身出席或通過會 議電話或其他通訊設備（所有與會者均 ...

美国证券交易委员会 华盛顿特区 20549 _____________________ ______________________ 根据 1934 年证券交易法 第 13 或 15（d）条规定提交的 临时报告 报告日期（所报告最早事件之日期）：2025 年 5 月 27 日 百济神州有限公司 BEONE MEDICINES LTD. （注册人章程中列明的注册人准确名称） 瑞士 001-37686 98-1209416 （注册地所在州或其他司法管辖区） （委员会档案编号） （国税局雇主识别号） c/o BeOne Medicines I GmbH 4051 Aeschengraben 27, 21st Floor （邮政编码） Basel, Switzerland （主要办事处地址） +41-616851900 （注册人电话号码，包括区号） BeiGene, Ltd. c/o Mourant Governance Services (Cayman) Limited Grand Cayman Cayman Islands KY1-1108 电话： (345) 949-4123 （此前名称和此前住址，如自上次报告 ...