Core Viewpoint - Hansoh Pharmaceutical (03692.HK) has received acceptance for its application for marketing authorization of the high-selectivity RET inhibitor HS-10365 capsules from the National Medical Products Administration, aimed at treating adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are RET gene fusion positive [1] Company Overview - Hansoh Pharmaceutical is an innovation-driven pharmaceutical company that has consistently ranked among the top 100 global pharmaceutical companies for several years [1] - The company has developed a total of 7 innovative drugs that generate sales revenue in China, establishing a rich product pipeline [1]

Core Viewpoint - Hansoh Pharmaceutical (03692.HK) has received acceptance from the National Medical Products Administration for its New Drug Application (NDA) for HS-10365 capsules, a selective RET inhibitor aimed at treating adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with RET gene fusion [1] Group 1: Product Development - HS-10365 is a first-class innovative drug developed by Hansoh Pharmaceutical [1] - It is a small molecule, highly selective RET receptor tyrosine kinase inhibitor [1] - The drug works by competitively binding to intracellular protein tyrosine kinases with ATP, inhibiting tyrosine kinase phosphorylation, and effectively controlling tumor growth [1]

Core Viewpoint - Hansoh Pharmaceutical (03692) announced that its innovative drug HS-10365, a highly selective translocation inhibitor, has received acceptance for its New Drug Application (NDA) by the National Medical Products Administration (NMPA) of China on October 23, 2025, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with RET gene fusion [1] Group 1 - The drug HS-10365 is specifically designed for patients with RET gene fusion positive NSCLC [1] - The acceptance of the NDA marks a significant step in the drug's development and potential market entry [1] - This development highlights the company's focus on innovative treatments in oncology [1]

Core Viewpoint - Hansoh Pharmaceutical (03692) has received acceptance for its New Drug Application (NDA) for the innovative drug HS-10365 capsule by the National Medical Products Administration (NMPA) in China, aimed at treating adult patients with RET gene fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) [1] Group 1 - The NDA for HS-10365 was accepted on October 23, 2025 [1] - The drug targets a specific patient population with RET gene fusion-positive NSCLC [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。 Hansoh Pharmaceutical Group Company Limited 自願公告 HS-10365膠囊上市許可申請 獲國家藥品監督管理局受理 翰森製藥集團有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董 事會」）欣然宣佈，於二零二五年十月二十三日，本集團創新藥高選擇性轉染重 排（「RET」）抑制劑HS-10365膠囊上市許可申請(NDA)獲中國國家藥品監督管 理局(NMPA)受理，用於RET基因融合陽性的局部晚期或轉移性非小細胞肺癌 (NSCLC)成人患者的治療。 承董事會命 翰森製藥集團有限公司 主席 鍾慧娟 香港，二零二五年十月二十三日 於本公告日期，董事會成員包括主席兼執行董事鍾慧娟女士、執行董事孫遠女士 及呂愛鋒博士；及獨立非執行董事林國強先生、陳尚偉先生及楊東濤女士。 翰森製藥集團有限公司 （於開曼群島註冊成立的有限公司） （股份代號：3692） ...

Core Viewpoint - The Hong Kong stock market's innovative drug sector is experiencing a decline, with the Hong Kong Stock Connect Innovative Drug ETF (520880) dropping over 3.5% as of the report, indicating a potential buying opportunity for investors despite the downturn [1] Group 1: Market Performance - The Hong Kong Stock Connect Innovative Drug ETF (520880) has seen a trading volume exceeding 200 million yuan, continuing to exhibit high premiums in the market [1] - The innovative drug sector faced a significant drop recently, with the ETF attracting over 75 million yuan in a single day, totaling over 120 million yuan in the last four days [1] Group 2: Recent Developments - The ESMO 2025 conference recently showcased positive data for several core projects of Chinese innovative drugs [1] - On October 22, Innovent Biologics announced a global strategic partnership with Takeda Pharmaceutical worth 11.4 billion USD, setting a record for the value of business development (BD) transactions in China's innovative drug sector, involving three product rights and pipeline development [1] Group 3: Future Outlook - Huafu Securities suggests that the recent adjustments in the Hong Kong innovative drug sector may present a significant opportunity for investment in late October [1] - The long-term outlook remains positive for companies with commercialization capabilities and rich pipelines, particularly in BioPharma, potential BD targets, and cutting-edge technology [1] - The innovative drug industry is expected to benefit from interest rate cuts, with performance anticipated to improve, and the end-of-year BD period may act as a catalyst for growth [1] Group 4: Index Composition - The Hong Kong Stock Connect Innovative Drug ETF (520880) and its linked fund (025220) passively track the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index, which includes top ten weighted stocks such as BeiGene, China Biologic Products, Innovent Biologics, and others [1]

Group 1 - The 2025 European Society for Medical Oncology (ESMO) annual meeting held in Berlin is recognized as one of the most influential oncology conferences globally, showcasing significant breakthroughs in research data from Chinese pharmaceutical companies [1] - The event is seen as a key catalyst for the international expansion of Chinese innovative drugs, with high-quality data disclosure being crucial for international collaboration [1][3] - A total of 2,929 abstracts were presented at the conference, with 448 from Chinese companies, indicating a strong presence and recognition of China's innovation capabilities [2] Group 2 - Chinese pharmaceutical companies showcased their innovative capabilities through clinical data presentations, with 23 studies selected for the latest breakthrough abstracts (LBA), a significant increase from 7 in 2024 [2] - Notable companies like Jiangsu Hengrui Medicine Co., Ltd. presented multiple LBA studies, highlighting their commitment to international research and development strategies [2] - The conference served as a foundation for further international market expansion, with positive clinical data acting as a catalyst for business development (BD) collaborations with major international pharmaceutical companies [3] Group 3 - The total value of overseas BD transactions for Chinese innovative drugs reached $387 billion in the first nine months of the year, nearing the total for the entire previous year [3] - Recent BD agreements, such as the one between Hansoh Pharmaceutical Group and Roche, indicate ongoing interest and activity in the sector [4] - Industry experts predict that while the total transaction value may not reach new highs, the overall number of BD transactions will remain substantial, driven by ongoing innovation and supportive policies [4][5]

Core Insights - The innovative drug sector is experiencing a surge in business development (BD) transactions, with at least five deals announced in a short span, totaling over $200 million in upfront payments and a potential total value of $4.266 billion [2][4][8] - The recent ESMO annual meeting has provided critical clinical data that supports the valuation of innovative drug assets, coinciding with the traditional peak period for BD transactions in the fourth quarter [2][14] Summary by Category Market Activity - In mid-October, at least five BD transactions in the innovative drug sector were completed, with a total upfront payment exceeding $200 million and a potential total value of $4.266 billion, covering areas such as immunology, ophthalmology, and oncology [2][4] - Major multinational corporations (MNCs) like Roche and Kite Pharma are actively engaging with Chinese companies for licensing agreements, indicating a strong interest in innovative drug assets [3][4] Transaction Details - The largest deal involved Prigen, which secured a total of $1.64 billion for its CAR-T therapy targeting solid tumors, with an upfront payment of $120 million, marking it as a leading figure in the domestic CAR-T licensing landscape [4][8] - Other notable transactions include Hansoh Pharma's collaboration with Roche for its CDH17 ADC drug, valued at $1.53 billion with an upfront payment of $80 million, and collaborations involving dual antibodies and other innovative therapies [5][8] Clinical and Academic Support - The ESMO annual meeting has showcased significant clinical data from Chinese companies, enhancing the credibility of their innovative drug assets and facilitating BD transactions [14][15] - The participation of Chinese firms in ESMO has increased, with numerous studies presented, indicating a growing presence in the global oncology landscape [14][15] Industry Trends - The fourth quarter is historically a peak period for BD transactions, with data showing that 40% of annual BD activity occurs in this timeframe, driven by both domestic companies seeking to boost annual performance and MNCs completing strategic asset acquisitions [9][10] - The overall growth of the innovative drug sector is evident, with a reported 170% year-on-year increase in the total value of innovative drug patent licensing agreements from January to September 2023, exceeding $100 billion [10][12]

Core Insights - Hansoh Pharmaceutical has secured a significant business development (BD) deal worth up to $1.53 billion with Roche for the global rights (excluding Greater China) to its investigational CDH17-targeted antibody-drug conjugate (ADC) HS-20110 [1][2] - The deal includes an upfront payment of $80 million, potential milestone payments of up to $1.45 billion, and a share of future sales [1][2] - This transaction highlights Hansoh's strategic shift from generics to innovative drugs, with innovative drug revenue projected to account for over 80% of total revenue by mid-2025 [1][7] Business Development Strategy - Hansoh has successfully executed multiple BD transactions in the ADC field, totaling approximately $4.8 billion across three major deals, including recent agreements with GSK for other ADCs [3][4] - The company employs a dual strategy of license-in and license-out to expand its product pipeline, having completed over 20 BD transactions since 2019 [5][6] - Recent license-in agreements include collaborations with three companies to develop new drugs, with ongoing clinical trials for several candidates [6] Financial Performance - In the first half of 2025, Hansoh reported revenues of 7.434 billion yuan, a year-on-year increase of 14.27%, with net profit attributable to shareholders reaching 3.135 billion yuan, up 15.02% [7] - Sales from innovative drugs and collaborative products accounted for 82.17% of total revenue during the same period [7] Company Background - Hansoh Pharmaceutical was founded in 1995 by Sun Piaoyang and his wife Zhong Huijuan, who have played pivotal roles in the company's growth and transition from generics to innovative pharmaceuticals [8][9] - The company has a history of launching significant generic products and has now established a strong presence in the innovative drug market, with several products already on the market [5][6] Market Position - The recent BD deal with Roche and previous agreements reflect the growing trend of Chinese ADCs entering global markets, showcasing the country's R&D capabilities in this area [3][4] - Hansoh's stock has seen significant appreciation, with a 115.3% increase since the beginning of 2025, indicating strong market confidence in the company's future prospects [10]

Core Insights - The Hong Kong Innovative Drug ETF (159567) closed down 0.46% on October 20, with a trading volume of 907 million yuan [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of October 17, 2024, the fund's shares totaled 8.134 billion, with a total size of 6.968 billion yuan, reflecting a significant increase in both shares and size compared to the previous year [1] Fund Performance - The fund has seen a remarkable increase of 1957.27% in shares and 1744.35% in size since December 31, 2023 [1] - The fund's cumulative trading amount over the last 20 trading days reached 27.487 billion yuan, with an average daily trading amount of 1.374 billion yuan [1] - Year-to-date, the cumulative trading amount is 224.063 billion yuan, averaging 1.173 billion yuan per day over 191 trading days [1] Fund Management - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 71.34% during the management period [2] - The fund's top holdings include companies such as Innovent Biologics, WuXi Biologics, BeiGene, and others, with significant percentages of the portfolio allocated to these stocks [2]