人民财讯9月17日电，9月17日，香港特区行政长官李家超在立法会发表2025年《施政报告》。李家超表 示，香港生命健康科研发展蓬勃，具备成熟的"政产学研投"系统，配合国家自主研发创新药的崛起，并 透过专利授权开拓国际市场，为香港带来极大经济和战略机遇。香港会吸引更多药企落户香港，进行罕 见病药、高端肿瘤药及先进疗法制品等临床试验和治疗。积极提升患者招募及试验启动效率；并透过河 套的"大湾区临床试验协作平台"，让药企在港深同步开展试验。同时筹备成立"国际临床试验学院"，培 育大湾区临床试验人才，以及举办国际高峰会议和论坛等。 ...

Group 1 - The core event is a clinical trial matchmaking meeting held at Suzhou University Affiliated First Hospital, facilitating direct discussions between 11 local biopharmaceutical companies and medical experts [1] - Suzhou has over 4,200 biopharmaceutical companies, most of which are in the growth stage, with 133 clinical trial projects conducted locally last year, representing a 51.14% year-on-year increase [1] - The local medical institutions, represented by Suzhou University Affiliated First Hospital, have significantly improved their clinical trial capabilities, which is expected to accelerate the implementation of more clinical trial projects in local healthcare facilities [1] Group 2 - Suzhou has developed a number of well-known innovative drug and device R&D companies in areas such as antibody drugs, cell and gene therapy, and in vitro diagnostics, including 26 national-level platforms [2] - Clinical trials are identified as an essential core step in transforming biopharmaceutical discoveries into practical methods for disease prevention, diagnosis, and treatment [2] - The Suzhou Industrial and Information Technology Bureau is encouraging local enterprises to conduct clinical trials and is exploring the establishment of special funding projects to support these initiatives [2]

Summary of Vaxcyte (PCVX) Conference Call Company Overview - Vaxcyte is focused on developing vaccines, particularly utilizing a proprietary cell-free protein synthesis platform for precise conjugation of vaccine immunogens [2][3] - The lead vaccine candidate is Vax 31, targeting pneumococcal diseases, with promising results in adults and an ongoing Phase 2 study in infants [3][4] Key Developments - Vax 31 has received positive feedback from the FDA, allowing the transition from Phase 2 to Phase 3 clinical development [6][8] - The Phase 3 pivotal study for Vax 31 is set to begin in Q4 2025, with results expected in 2026 and 2027, aiming for a Biologics License Application (BLA) filing in late 2027 and potential approval in 2028 [7][8] Market Insights - The pneumococcal vaccine market is valued at approximately $8 billion, with expectations to grow to $13 billion, driven primarily by the adult segment [30][21] - Current market split is 75% pediatric and 25% adult, but growth is anticipated in the adult market due to expanded vaccination recommendations [28][30] Clinical Development Strategy - The Phase 3 program will include a non-inferiority study and additional studies to enhance the vaccine's label, including safety assessments in high-risk populations [13][14][17] - The adult market is expected to see significant growth due to recommendations for vaccination starting at age 50 [28][30] Manufacturing and Regulatory Considerations - The complexity of manufacturing a 31-valent vaccine has been acknowledged, with significant investment in Chemistry, Manufacturing, and Controls (CMC) to ensure compliance with FDA standards [20][21] - The FDA has provided guidance that allows Vaxcyte to proceed without the need for a placebo-controlled study, which is a significant advantage [8][10] Infant Vaccine Development - Enrollment has resumed in the Phase 2 study for infants with an optimized dosing strategy, aiming to improve immune responses [34][35] - The study will evaluate multiple dosing cohorts, with results expected by 2027 [38][49] Financial Position - Vaxcyte reported a strong balance sheet with $2.8 billion as of June 30, allowing for extended operational runway until 2028 [59][60] - Strategic decisions have been made to preserve the PCB franchise while deferring some pipeline programs to extend financial resources [60] Conclusion - Vaxcyte is positioned for significant developments in the vaccine market, with a strong focus on both adult and infant immunization strategies, backed by a solid financial foundation and regulatory support [61][62]

Financial Data and Key Metrics Changes - The company received approval for Midaso or Dodavapene ahead of the PDUFA date, indicating strong progress in regulatory interactions with the FDA [4] - Strong results were reported for Xywav, with approximately 400 net patient additions in the second quarter for idiopathic hypersomnia, where it is the only approved treatment [6][7] Business Line Data and Key Metrics Changes - Xywav continues to perform well in both idiopathic hypersomnia and narcolepsy, with significant growth driven by the unique low sodium formulation that appeals to patients and physicians [15][17] - The oncology segment is seeing exciting developments, particularly with the upcoming Zepzelca approval and ongoing trials for Zanidatamab, which is expected to yield important data in the fourth quarter of 2025 [9][10] Market Data and Key Metrics Changes - The market for small cell lung cancer is becoming more competitive, but the company is optimistic about Zepzelca's potential in both first-line and second-line settings [50][51] - The company is preparing for potential competition from generics in the oxybate market, particularly with the anticipated introduction of generic Xyrem in early 2026 [19][20] Company Strategy and Development Direction - The company is focused on driving value through its existing assets while exploring new opportunities in rare oncology and epilepsy [56] - The new CEO, Renée Galá, is expected to bring fresh insights and leadership to further the company's strategic goals [6][58] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming clinical data and the potential for both Zanidatamab and Dodavapene to change the standard of care in their respective indications [57][58] - The company is prepared for various market scenarios, particularly regarding the impact of generics on its revenue streams [19][20] Other Important Information - The company has completed a licensing transaction to enhance its epilepsy franchise, indicating a proactive approach to expanding its portfolio [5] - Management emphasized a disciplined approach to managing expenses while investing in high-potential R&D opportunities [53][54] Q&A Session Summary Question: How is Xywav performing amidst competition? - Management noted that Xywav has shown strong growth, particularly in idiopathic hypersomnia, and they expect this trend to continue [15][17] Question: What are the expectations regarding generics entering the market? - Management is planning for various scenarios, including the potential impact of generics on revenue, and is prepared to adapt to market conditions [19][20] Question: How does the company view the competitive landscape for Durexins? - Management sees Durexins as a potent adjunctive therapy for narcolepsy, which could improve patient outcomes without replacing oxybate therapy [25][26] Question: What is the outlook for Zanidatamab's clinical trials? - Management is optimistic about the upcoming data readouts and believes the active arms of the trial could perform better than initially anticipated [29][30] Question: How is the company managing operating expenses while pursuing growth? - Management emphasized a focus on high-impact investments in R&D while maintaining tight control over SG&A expenses [53][54]

Financial Data and Key Metrics Changes - The meeting reported the election of directors and the approval of an amendment to the stock option plan, indicating a stable governance structure and potential for future growth [7][8]. Business Line Data and Key Metrics Changes - No specific financial data or metrics related to individual business lines were provided during the meeting [9]. Market Data and Key Metrics Changes - The company is currently conducting a Phase I clinical trial with a total of 16 patients treated, indicating ongoing engagement in clinical research [10][11]. Company Strategy and Development Direction - The company is focused on advancing its clinical trials and plans to announce specific results in September, reflecting a commitment to transparency and progress in research [11]. Management Comments on Operating Environment and Future Outlook - Management acknowledged the diverse range of tumor types represented in the clinical trial, suggesting a broad market approach and adaptability in research [10]. - Future announcements regarding trial results are anticipated, which may impact investor sentiment and market perception [11]. Other Important Information - The meeting concluded with a focus on shareholder engagement and the importance of upcoming trial results, highlighting the company's commitment to its stakeholders [12]. Q&A Session Summary Question: How many patients are currently undergoing Transcode clinical studies? - The company reported that 16 patients have been treated in the Phase I clinical trial, with more details expected in September [10][11]. Question: How many have dropped out and for what reasons? Are there patients with demonstrated tumor regressions so far? - The company did not provide specific dropout rates or reasons but confirmed that the trial is open to a wide range of tumor types, indicating a comprehensive approach to patient selection [10].

Core Viewpoint - Heptagon Pharmaceuticals-B (02142) has seen a stock price increase of over 5%, currently trading at HKD 13.36, with a trading volume of HKD 85.495 million. The company announced a placement agreement to issue 45.022 million shares at HKD 11.50 each, representing a discount of approximately 9.45% from the closing price of HKD 12.70 on August 28, 2025. The net proceeds of approximately HKD 511.7 million will be allocated to R&D for innovative drug assets, clinical trials for existing pipeline drugs, and general corporate purposes [1]. Financial Performance - Heptagon Pharmaceuticals recently reported interim results with revenue of approximately USD 101 million, reflecting a year-on-year increase of about 327%. The net profit for the period was USD 72.999 million, showing a significant year-on-year growth of 5,125%. The increase in revenue was primarily driven by licensing fees, which rose from USD 20.8 million to USD 93.7 million due to strategic collaborations with global pharmaceutical companies and new licensing agreements for innovative products. Additionally, research services and technology licensing fees increased by 164.9%, from USD 2.9 million to USD 7.6 million [1].

Group 1 - The company, Heptagon Pharmaceuticals-B (02142), has entered into a placement agreement with a placement agent to issue a total of 45.022 million shares at a price of HKD 11.50 per share, conditional upon the agreement [1] - The placement price of HKD 11.50 represents a discount of approximately 9.45% compared to the closing price of HKD 12.70 on August 28, 2025 [1] - If all 45.022 million shares are fully subscribed, the net proceeds are expected to be approximately HKD 511.7 million [1] Group 2 - Approximately 50% of the net proceeds will be allocated for the research and development of innovative drug assets [1] - About 40% of the funds will be used to advance clinical trials for existing pipeline drug assets [1] - The remaining 10% will be designated for working capital and other general corporate purposes [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，並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定，江蘇恒瑞醫藥股份有限公司（「本公司」）在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下，僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2025年8月20日 於本公告日期，董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生；(ii)非執行董事郭叢照女士；及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 江苏恒瑞医药股份有限公司 2025 年半年度报告 公司代码：600276 ...

Group 1 - Gao Yi Asset recently conducted research on BeiGene, indicating that the net price of Baiyueze in the U.S. has seen a mid-single-digit percentage increase, with price stability expected throughout the year [1] - Baiyueze has been approved in 75 markets, while Baizean has received approval in 47 markets, with plans for continued global regulatory expansion [1] - The revenue guidance adjustment is based on Baiyueze's leading position in the U.S. and rapid growth in Europe and other markets, leading to a diversified revenue structure [1] Group 2 - Gross margin growth is attributed to improved production efficiency of Baiyueze and Baizean, with considerations for tariff policy impacts [1] - The ORR data from the BRUIN CLL-314 study lacks statistical significance, while the ALPINE study shows Baiyueze outperforming Ibrutinib [1] - BTK CDAC is being explored for applications in immunology and inflammation, with plans for a Phase III clinical trial to start in the second half of 2025 [1] Group 3 - The Phase III trial for CDK4 inhibitors has been postponed to early 2026, with dose optimization data expected to be released this year, indicating a positive market outlook for breast cancer treatment [1] - Key Phase II trials for BTK CDAC are scheduled for 2026, with registration submissions planned [1]

Financial Data and Key Metrics Changes - Total revenue grew by 11% in the first half of 2025, driven by strong demand for innovative medicines [8][14] - Core EPS increased by 17%, reflecting the company's focus on pipeline investment and operating leverage [8][17] - Operating expenses rose by 9%, which is below the revenue growth rate, indicating improved efficiency [16] - Net cash flow from operating activities increased by 27% to $7.1 billion in the first half [20] Business Line Data and Key Metrics Changes - Oncology total revenues grew by 16% to $12 billion, with strong growth in the U.S., Europe, and emerging markets [23] - Biopharmaceuticals revenue increased by 10% to $11.2 billion, with R&I growing by 13% [41] - Rare disease revenue returned to growth, up 7% in the second quarter, with Ultomiris growing by 23% [53] Market Data and Key Metrics Changes - Strong growth was noted in the U.S. and emerging markets, particularly in oncology and biopharmaceuticals [10] - The growth rate in China was affected by Pulmicort generics, but underlying demand remained strong [10] Company Strategy and Development Direction - The company aims to achieve $80 billion in revenue by 2030, with a focus on pipeline delivery and regulatory approvals [12][62] - Investments in transformative technologies are expected to drive growth beyond 2030 [62] - The company is committed to maintaining a diverse portfolio to mitigate risks associated with regional disruptions [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory, citing strong performance in core products and a robust pipeline [19][61] - The company anticipates continued operating leverage and margin improvement, despite expected challenges from generic competition [16][19] Other Important Information - The company announced a new multibillion-dollar manufacturing facility in the U.S. to support its innovative portfolio [20] - Significant investments are planned in R&D and manufacturing as part of a $50 billion investment plan in the U.S. [20] Q&A Session Summary Question: How much do you now need Avansar to work to deliver your $80 billion in 2030 revenue target? - The company does not need Avansar to achieve the $80 billion target, as it is a risk-adjusted number across the total portfolio [68] Question: How exciting is VEGF for lung cancer combinations? - The company is exploring VEGF combinations with its bispecific portfolio, indicating potential benefits in lung cancer [72] Question: What are the revenue opportunities for Imfinzi in bladder and gastric cancer? - The bladder cancer opportunity is considered a blockbuster, with strong uptake expected from ongoing studies [79] - The Matterhorn study in gastric cancer is also viewed as a significant opportunity [80] Question: How will InHER2 be integrated into the first line HER2 positive setting in breast cancer? - The expectation is that InHER2 will be utilized in line with the clinical study, with a focus on maximizing patient outcomes [81]