Core Viewpoint - Henlius USA Inc., a wholly-owned subsidiary of the company, has received Orphan-drug Designation from the FDA for HLX43, a targeted PD-L1 antibody-drug conjugate intended for the treatment of thymic epithelial tumors (TETs) [1][2] Group 1: Product Development - HLX43 is a novel antibody-drug conjugate developed by the company, combining a DNA topoisomerase I inhibitor with a self-developed PD-L1 targeting antibody, aimed at treating advanced/metastatic solid tumors [1][2] - The Phase 1 clinical trial data for HLX43, particularly in lung cancer populations, will be updated at the World Conference on Lung Cancer (WCLC) in September 2025, showing a 37.0% objective response rate (ORR) and an 87.0% disease control rate (DCR) in patients with advanced solid tumors [2] Group 2: Regulatory and Market Implications - The Orphan-drug Designation from the FDA will facilitate the subsequent research, registration, and commercialization of HLX43 for TETs in the U.S., providing benefits such as tax credits for clinical trial costs, waiver of new drug application fees, and seven years of market exclusivity post-approval [2] - If other similar drugs for the same indication are approved before HLX43, the company must demonstrate clinical superiority to maintain the market exclusivity benefits associated with the Orphan-drug status [3]

Core Viewpoint - Henlius USA Inc., a wholly-owned subsidiary of the company, has received Orphan-drug Designation from the FDA for HLX43, a targeted PD-L1 antibody-drug conjugate for the treatment of thymic epithelial tumors (TETs) [1][2]. Group 1: Product Development - HLX43 is a novel targeted PD-L1 antibody-drug conjugate developed by the company, combining a small molecule toxin-peptide linker with a self-developed PD-L1 targeting antibody [1]. - The drug is intended for the treatment of advanced/metastatic solid tumors, particularly in patients with non-small cell lung cancer (NSCLC) who have failed prior checkpoint inhibitors and chemotherapy [2]. Group 2: Clinical Data - Phase 1 clinical trial data presented at the 2025 World Lung Cancer Conference (WCLC) showed HLX43 has a 37.0% objective response rate (ORR) and an 87.0% disease control rate (DCR) in advanced solid tumors, especially in post-line resistant NSCLC patients [2]. - Preliminary efficacy was also encouraging in patients with thymic squamous cell carcinoma (TSCC) as reported at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [2]. Group 3: Regulatory and Market Implications - The Orphan-drug Designation from the FDA will facilitate the subsequent research, registration, and commercialization of HLX43 for TETs in the U.S., providing benefits such as tax credits for clinical trial costs, exemption from new drug application fees, and seven years of market exclusivity post-approval [2]. - If another drug for the same indication is approved before HLX43, the company must demonstrate clinical superiority to maintain the market exclusivity benefits associated with the Orphan-drug status [3].

Core Viewpoint - Henlius USA Inc., a wholly-owned subsidiary of the company, has received Orphan-drug Designation from the FDA for HLX43, a targeted PD-L1 antibody conjugate for the treatment of thymic epithelial tumors (TETs) [1] Group 1 - The FDA has granted Orphan-drug Designation for HLX43, indicating its potential significance in treating a rare condition [1] - HLX43 is specifically developed as a targeted therapy for thymic epithelial tumors, which are rare types of tumors [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。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） 自願公告 注射用HLX43（靶向PD-L1抗體偶聯藥物）用於胸腺上皮腫瘤(TETs) 治療獲美國食品藥品管理局(FDA)授予孤兒藥資格認定 A. 緒言 本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）自願作出，以告知 本公司股東及潛在投資者本公司最新業務更新。 本公司董事會（「董事會」）欣然宣佈，近日，本公司全資子公司Henlius USA Inc.收到美國食品藥品管理局（「FDA」）的函，注射用HLX43（靶向PD-L1抗體 偶聯藥物）（「HLX43」）用於胸腺上皮腫瘤(TETs)治療獲FDA授予孤兒藥資格 認定(Orphan-drug Designation)。 B. 關於HLX43 HLX43是由本公司利用許可引進的新型DNA拓撲異 ...

Summary of the Conference Call for 福翁翰林 Company Overview - 福翁翰林 has nearly 50 high-quality product pipelines, including established products like Rituximab, Trastuzumab, and Bevacizumab, which are entering a growth phase, supporting revenue and profit margin increases [2][3][6] - The company has launched four commercialized biosimilars, including Rituximab and Trastuzumab, with projected revenue of 7.013 billion RMB by 2027 [3][15] Key Products and Developments - **Helix 43**: A PD-L1 ADC asset with global Best in Class potential, it is the second PD-L1 ADC to enter clinical trials globally and the first in China. Phase I clinical data shows an ORR of 36.8% and a DCR of 100% in brain metastasis patients [2][5][9] - **Helix 22**: An innovative HER2 monoclonal antibody recognized as an orphan drug by the FDA and Europe for gastric cancer treatment. Phase II clinical data shows a 24-month PFS rate of 54.8% and an ORR of 87.1% [2][11] - **斯鲁利单抗**: The first PD-1 monoclonal antibody approved for extensive small cell lung cancer, with global revenue reaching 1.3 billion RMB by 2024, covering 40 countries [2][12][13] - **Combination Trials**: 斯鲁利单抗 combined with Bevacizumab and chemotherapy in a Phase III trial for first-line colorectal cancer shows significant survival extension and good safety data [2][14] Clinical Trials and Market Potential - 福翁翰林 is conducting over 30 clinical trials covering 19 products, with potential for international licensing [3][5] - The company is in the internationalization 2.0 phase, with a comprehensive pipeline including protein drugs, ADCs, and small molecules targeting oncology and autoimmune diseases [6][7] Financial Performance and Future Outlook - The company has shown good financial health with revenue growth supported by commercialized products and effective cost control, leading to stable cash flow [6][7] - Plans for full circulation of Hong Kong stocks are expected to enhance liquidity and attract more capital market opportunities [4][6] Competitive Landscape - The global biosimilar market is projected to grow significantly, with 福翁翰林 positioned to capitalize on this trend through its established products and ongoing clinical developments [15][16] International Collaboration - 福翁翰林 utilizes a License out model to expand its international market presence and collaborates with high-quality partners to enhance its product offerings [16][17] Conclusion - 福翁翰林's strong R&D capabilities, mature commercialized products, and robust financial performance position it for continued rapid growth in the biopharmaceutical industry [6][7]

Core Viewpoint - The 2025 Sustainable Global Leaders Conference held in Shanghai emphasizes global action, innovation, and sustainable growth, featuring around 500 attendees including Nobel Prize winners and leaders from Fortune 500 companies [1] Group 1: Innovation and Globalization - Fosun International's co-chairman, Wang Qunbin, highlighted the company's journey of globalization driven by innovation, aiming for a win-win in commercial and social value [3] - Fosun has developed the first approved anti-PD-1 monoclonal antibody, H drug, for the treatment of extensive-stage small cell lung cancer, which has been approved in nearly 40 countries, benefiting over 110,000 patients globally [4][5] - The company is transitioning from "following" to "leading" in the innovative drug sector, focusing on unmet clinical needs and global partnerships to advance healthcare [5] Group 2: Global Value Creation - Fosun has established a global presence in over 40 countries, building capabilities in research, registration, business development, and marketing, with its innovative biopharmaceutical products reaching nearly 600,000 patients [6] - The company has achieved significant growth in business development contracts, with cash inflow exceeding 1 billion yuan, a 280% increase year-on-year [6] - In the tourism sector, Fosun is enhancing customer experience through AI digital upgrades, expanding its services across 12 countries [6] Group 3: Corporate Social Responsibility - Fosun emphasizes the importance of ESG (Environmental, Social, Governance) responsibilities, contributing to global malaria control by supplying over 420 million doses of artemisinin-based injections [8][9] - The company has initiated a rural doctor project in China, benefiting 3 million rural families and over 16 million rural residents [9] - Fosun maintains a strong MSCI ESG rating of AA and is recognized in the top 1% of Chinese companies for sustainability efforts [9][10] Group 4: Future Vision - Wang Qunbin stated that the power of business for good is driving profound changes in the relationship between enterprises and society, and Fosun aims to continue climbing new heights in sustainable development [10]

Core Viewpoint - The pharmaceutical stocks continue to rise, reflecting positive market sentiment and investor interest in the sector [1] Group 1: Stock Performance - Zai Lab Limited (荃信生物-B, 02509.HK) increased by 7.04%, reaching HKD 29.2 [1] - Junshi Biosciences (复宏汉霖, 02696.HK) rose by 6.84%, trading at HKD 75 [1] - I-Mab (映恩生物-B, 09606.HK) saw a gain of 5.41%, with shares priced at HKD 331 [1] - Rongchang Biologics (荣昌生物, 09995.HK) experienced a 5.53% increase, now at HKD 96.3 [1] - CanSino Biologics (康方生物, 09926.HK) grew by 5.25%, with a share price of HKD 128.4 [1]

Core Viewpoint - The pharmaceutical sector continues its upward trend, driven by upcoming catalysts and significant clinical data expected from the European Society for Medical Oncology (ESMO) conference in October 2025 [1] Group 1: Stock Performance - Pharmaceutical stocks have shown notable increases, with specific companies like Qianxin Biotech-B (02509) rising by 7.04% to HKD 29.2, and Fuhong Hanlin (02696) increasing by 6.84% to HKD 75 [1] - Other companies such as Ying'en Biotech-B (09606), Rongchang Biotech (09995), and Kangfang Biotech (09926) also reported gains of 5.41%, 5.53%, and 5.25% respectively [1] Group 2: Market Trends - The pharmaceutical sector has experienced significant stock price volatility since October, with a slight decrease in the proportion of domestic capital holding pharmaceutical stocks through the Hong Kong Stock Connect [1] - Foreign investment has also shown a declining trend since mid-year, although the overall direction of increasing investment in innovative drugs remains unchanged [1] Group 3: Upcoming Catalysts - The ESMO conference, scheduled for October 17-21 in Berlin, is expected to present critical clinical research results and related clinical data, which will be a focal point for the market [1] - Analysts suggest that the upcoming third-quarter earnings reports and the national medical insurance negotiations in November will also be significant events to watch [1] Group 4: Industry Outlook - The Chinese innovative drug sector is anticipated to undergo a transformation driven by quantitative changes leading to qualitative improvements over the next 5-10 years [1] - Factors such as business development (BD) overseas, continuous data catalysts, and the ramp-up of new product sales are expected to drive the rise of innovative drugs [1]

Group 1 - The pharmaceutical sector continues its upward trend, with notable stock increases for companies such as Qianxin Biotech-B (up 7.04%), Fuhong Hanlin (up 6.84%), and others [1] - The upcoming European Society for Medical Oncology (ESMO) conference from October 17 to 21, 2025, in Berlin is expected to showcase significant clinical research results and related clinical data [1] - Despite a slight decrease in the proportion of domestic capital holding pharmaceutical stocks through the Hong Kong Stock Connect, the overall trend of increasing investment in innovative drugs remains unchanged [1] Group 2 - The ESMO annual meeting is anticipated to highlight clinical data for Chinese innovative drugs, which is expected to be a major focus for the market [2] - The third-quarter earnings reports and the national medical insurance negotiations in November are also recommended for attention [2] - The trend of Chinese innovative drugs is expected to undergo a transformation driven by factors such as international business development, continuous data catalysts, and the ramp-up of new product sales over the next 5-10 years [2]

每经AI快讯，复宏汉霖(02696.HK)午后涨近6%，截至发稿，涨5.18%，报70.05港元，成交额7164.72万 港元。 ...