百济神州有限公司 关于公司 2025 年度"提质增效重回报"行动方案的 半年度评估报告 百济神州有限公司（以下简称"公司"）积极贯彻落实科创板上市公司"提 质增效重回报"专项行动，公司于 2025 年 4 月 29 日发布了《百济神州有限公司 2025 年度"提质增效重回报"行动方案》（以下简称"行动方案"），为推动专项 行动常态化，延续已经取得的效果，践行"致力于做生物科技产业的变革者，为 全世界的癌症患者提供有效、可及且可负担的药物"的使命，公司将持续在研发 创新、财务管理、公司治理及投资者关系等方面采取积极措施，以进一步提高公 司质量，保障投资者权益，促进公司健康可持续发展。 2025 年上半年，行动方案主要举措的落实和进展情况以及主要成果如下： 一、聚焦创新性肿瘤药物领域，巩固核心竞争力 公司是一家全球领先的肿瘤创新治疗公司，为全世界癌症患者研发创新抗肿 瘤药物，提升药物可及性和可负担性。 公司是血液肿瘤行业连续创新者，并已建立起差异化、完全自主拥有的产品 组合。这其中包括同类最佳布鲁顿氏酪氨酸激酶（BTK）抑制剂百悦泽®，以及 两款处于开发后期阶段的产品索托克拉（sonrotoclax，BCL2 抑 ...

Core Insights - BeiGene announced positive results from the Phase 1/2 clinical trial of its next-generation BCL2 inhibitor, Sotorasib, for treating adult patients with mantle cell lymphoma (MCL) who have previously received BTK inhibitors and anti-CD20 therapy [1][2] - The trial demonstrated significant and durable responses, indicating the potential of Sotorasib to provide the first BCL2 inhibitor treatment option for MCL patients if approved [1][2] Company Developments - The clinical study (BGB-11417-201) enrolled 125 adult patients with MCL, with 22 patients in the first part receiving daily doses of 160 mg or 320 mg of Sotorasib to assess safety and tolerability [1] - In the second part, 103 patients received the recommended daily dose of 320 mg to evaluate efficacy and safety [1] - The study achieved the primary endpoint of overall response rate (ORR) and showed positive results in secondary endpoints, including complete response rate (CRR), duration of response (DOR), and progression-free survival (PFS) [2] Regulatory Progress - BeiGene is submitting data to the FDA and global regulatory agencies to seek potential approval for Sotorasib in MCL indications [2] - The new drug application for Sotorasib for treating MCL and CLL/SLL patients has been accepted by the National Medical Products Administration (NMPA) in China and is under priority review [2] - A confirmatory Phase 3 study (BGB-11417-302) is ongoing, with the first patient enrolled earlier this year [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，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 BeOne Medicines Ltd. 百濟神州有限公司 （根據瑞士法律註冊成立的公司） （股份代號：06160） 自願性公告－業務發展最新情況 百濟神州宣佈索托克拉用於治療套細胞淋巴瘤(MCL)患者 的臨床研究取得積極結果 百濟神州有限公司（「百濟神州」或「本公司」）於2025年8月29日宣佈新一代且具有 同類最優潛力的在研BCL2抑制劑索托克拉用於治療既往接受過布魯頓氏酪氨酸激 酶(BTK)抑制劑和抗CD20治療的套細胞淋巴瘤(MCL)成人患者的1/2期臨床研究 (BGB-11417-201)取得積極結果，並計劃在即將召開的學術大會上公佈全部數據。 「對於MCL患者來說，疾病依然具有侵襲性，且治療選擇有限，療效也不盡如人 意。索托克拉的臨床研究結果表明其有潛力為MCL患者帶來顯著且持久的緩解。 若獲得批准，將為這部分患者提供首個BCL2抑制劑的治療選擇。」百濟神州全球 研發負責人汪來博士表示，「在過 ...

Group 1 - The stock price of BeiGene increased by 8.7%, reaching 268.5 CNY per share, marking a new high [1] - The total market capitalization of the company surpassed 413.45 billion CNY [1] - The trading volume amounted to 1.014 billion CNY [1]

Core Insights - The key factors for Chinese innovative pharmaceutical companies to stand out in the global competition include research and development speed, differentiation advantages, and the overall quality of scientists [1][3]. Group 1: Market Trends - In the first half of 2025, the number of transactions related to innovative drugs in China exceeded 50, with disclosed upfront payments for license-out transactions totaling $3.3 billion and total transaction amounts reaching $48.484 billion [2]. - The National Medical Products Administration reported that 43 innovative drugs were approved in the first half of 2025, a 59% year-on-year increase, nearing the total of 48 for the entire year of 2024 [2]. - China's innovative drug research pipeline accounts for approximately 25% of the global total, with around 3,000 clinical trials conducted annually, placing it among the world's leaders [2]. Group 2: Key Elements for Success - The speed of research and development is crucial in the AI era, and ensuring the authenticity of research data is also vital, as some companies have faced disputes due to data issues during international expansion [3]. - Investment logic is clearer in areas such as immunology, metabolism, cardiovascular diseases, and Alzheimer's disease, where the potential for drug development is promising [3]. - Companies must enhance their unique core competencies while understanding clinical needs and being willing to abandon less promising projects during the R&D phase [3]. Group 3: Investment Considerations - From an acquisition perspective, the lifecycle and maturity of the drug's market segment are critical; investors prefer projects in the growth phase with established breakthroughs [4]. - Differentiation in clinical value is essential for drugs that aim to enter international markets, and the efficiency of R&D can significantly impact a drug's competitive position [4]. Group 4: Global Expansion Strategies - By 2024, the number of innovative drugs under development in China reached 3,575, making it a global leader [5]. - The cumulative increase of the Hang Seng Biotechnology Index has reached 90.66% this year, significantly outperforming the Nasdaq Biotechnology Index [5]. Group 5: Practical Pathways for Companies - Chinese innovative pharmaceutical companies can leverage their experiences in universal healthcare systems to expand into Southeast Asia and Africa, where population growth is expected [6]. - The concept of "real-world asset" (RWA) tokenization is emerging as a new option for companies to participate in capital markets by packaging their drug-related rights [6]. Group 6: Transitioning to Multinational Corporations (MNCs) - The current overseas business development pricing for domestic innovative drugs is based on net asset valuation, indicating potential for significant premium in areas like scientific teams and market size [7]. - To become true MNCs, companies should establish local teams and manufacturing facilities while adapting to local regulations and building sales networks [7]. - The example of BeiGene illustrates the lengthy process of global market entry, emphasizing the need for careful assessment of time and financial investments required for international expansion [7].

证券时报•数据宝统计显示，百济神州所属的医药生物行业，目前整体涨幅为1.21%，行业内，目前股价上涨的有278只，涨停的有普蕊斯、华海药 业等3只。股价下跌的有204只，跌幅居前的有*ST苏吴、数字人、普瑞眼科等，跌幅分别为5.22%、4.60%、4.58%。 公司发布的半年报业绩快报数据显示，上半年公司共实现营业收入175.18亿元，同比增长46.00%，实现净利润4.50亿元，同比增长115.63%，基本 每股收益为0.3200元，加权平均净资产收益率1.76%。（数据宝）注：本文系新闻报道，不构成投资建议，股市有风险，投资需谨慎。 两融数据显示，该股最新（8月28日）两融余额为4.76亿元，其中，融资余额为4.69亿元，近10日减少7553.46万元，环比下降13.87%。 （原标题：百济神州创历史新高，融资客减仓） 机构评级来看，近10日共有3家机构对该股进行评级，8月15日中金公司证券发布的研报给予公司目标价为310.00元。 百济神州股价创出历史新高，截至11:04，该股上涨9.72%，股价报271.00元，成交量410.66万股，成交金额10.59亿元，换手率3.57%，该股最新A 股总市值达3 ...

Group 1 - Company reported a revenue of 2.433 billion RMB for the six months ending June 30, 2025, representing a year-on-year increase of 44.73% [1] - Gross profit reached 2.103 billion USD, up 48.33% year-on-year [1] - Net profit was 95.59 million USD, a turnaround from a net loss of 372 million USD in the same period last year, with basic earnings per share of 0.07 USD [1] Group 2 - Company signed a royalty purchase agreement with Royalty Pharma, receiving an upfront payment of 885 million USD for the rights to Tarlatamab outside of China [2] - The transaction is expected to secure 950 million USD in cash flow from Tarlatamab, covering nearly 80% of the 1.25 billion USD development costs committed in partnership with Amgen [2] - The deal is anticipated to strengthen the company's balance sheet and enhance operational and strategic flexibility, supporting ongoing innovation pipeline development [2]

Core Viewpoint - BeiGene (06160) reported a significant turnaround in its financial performance, achieving profitability and strong revenue growth, which has positively impacted its stock price and market perception [1][2]. Financial Performance - For the six months ending June 30, 2025, BeiGene reported total revenue of 2.433 billion RMB, a year-on-year increase of 44.73% [1] - Gross profit reached 2.103 billion USD, reflecting a 48.33% increase compared to the previous year [1] - The company achieved a net profit of 95.59 million USD, a significant improvement from a net loss of 372 million USD in the same period last year [1] - Basic earnings per share were reported at 0.07 USD [1] Revenue Drivers - The increase in total revenue was primarily driven by sales of the company's self-developed products, including Baiyueze and Tislelizumab, as well as sales from licensed products, mainly from Amgen [1] Strategic Developments - On August 25, BeiGene announced a significant licensing agreement with Royalty Pharma, which will pay 885 million USD upfront for most of the royalty rights to Tarlatamab (DLL3/CD3) outside of China [1] - This transaction is expected to secure 950 million USD in cash flow from the Imdelltra product, covering nearly 80% of the 1.25 billion USD development costs committed during the collaboration with Amgen [2] - The transaction is anticipated to strengthen BeiGene's balance sheet and enhance operational and strategic flexibility, supporting its ongoing innovation pipeline [2]

Group 1 - The stock price of BeiGene reached a historical high during trading, increasing by over 10% to 275.55 yuan [1]

每经AI快讯，百济神州A股盘中股价创历史新高，现涨超10%，报272.68元。 ...