Core Insights - Vor Bio announced clinical data from Stage A of a Phase 3 study in China for telitacicept, targeting IgA nephropathy (IgAN), to be presented at ASN Kidney Week 2025 [1][2] - Telitacicept achieved a primary endpoint with a 55% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) at 39 weeks compared to placebo, indicating significant efficacy [2] - RemeGen has submitted a Biologics License Application (BLA) for telitacicept in IgAN to the NMPA in China, which would mark its fifth approved indication in the country [3] Company Overview - Vor Bio is a clinical-stage biotechnology company focused on advancing telitacicept, a dual-target fusion protein, for treating autoimmune diseases [4] - Telitacicept selectively inhibits BLyS (BAFF) and APRIL, two cytokines essential for B cell survival, thereby reducing autoreactive B cells and autoantibody production [5] - The drug is already approved in China for systemic lupus erythematosus, rheumatoid arthritis, and generalized myasthenia gravis, with ongoing global Phase 3 trials for further approvals [6] Industry Context - IgA nephropathy is a leading cause of chronic kidney disease and end-stage renal disease, with up to 40% of patients progressing to ESRD within 20 years of diagnosis, highlighting the need for effective therapies [7] - Current treatments primarily slow disease progression without addressing the underlying immunopathology, indicating a significant unmet medical need [7] - The overproduction of galactose-deficient IgA1 is recognized as a central driver of IgAN, with BAFF and APRIL promoting its production [8]

格隆汇10月17日丨荣昌生物(09995.HK)公告，公司将于2025年10月30日(星期四)举行董事会会议，藉以 (其中包括)考虑及批准公司及其附属公司截至2025年9月30日止9个月未经审计第三季度业绩及其刊发。 ...

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。 RemeGen Co., Ltd.* 榮 昌 生 物 製 藥（ 煙 台 ）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：9995） 董事會召開日期 榮昌生物製藥（煙台）股份有限公司（「本公司」）之董事會（「董事會」）謹此宣佈， 本公司將於2025年10月30日（星期四）舉行董事會會議，藉以（其中包括）考慮及 批准本公司及其附屬公司截至2025年9月30日止九個月之未經審計第三季度業績 及其刊發。 承董事會命 榮昌生物製藥（煙台）股份有限公司 董事長兼執行董事 王威東先生 中華人民共和國，煙台 2025年10月17日 於本公告日期，董事會成員包括執行董事王威東先生、房健民博士、林健先生及 溫慶凱先生；非執行董事王荔強博士及蘇曉迪博士；及獨立非執行董事郝先經先 生、陳雲金先生及黃國濱先生。 * 僅供識別 ...

Trial met primary endpoint achieving statistically significant improvement in disease activity, with 67.1% of patients responding with telitacicept versus 32.7% with placebo Dual inhibition of BAFF and APRIL validated as a transformative B-cell approach, highlighting telitecicept’s potential as a disease-modifying therapy for systemic lupus erythematosus BOSTON, Oct. 16, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases ...

Core Insights - The biopharmaceutical sector experienced a slight increase of 0.13% on October 16, with Sanofi leading the gains [1] - The Shanghai Composite Index closed at 3916.23, up 0.1%, while the Shenzhen Component Index closed at 13086.41, down 0.25% [1] Biopharmaceutical Sector Performance - Sanofi (688336) saw a significant rise of 13.02%, closing at 59.90 with a trading volume of 177,400 shares and a transaction value of 1.063 billion [1] - Other notable gainers included: - Nossland (920047) up 4.09% to 25.46 with a transaction value of 125 million [1] - Rongchang Bio (688331) up 3.28% to 99.20 with a transaction value of 684 million [1] - Conversely, several companies experienced declines, including: - Anke Bio (300009) down 2.48% to 10.23 with a transaction value of 315 million [2] - Kain Technology (688687) down 1.92% to 28.62 with a transaction value of 169 million [2] Capital Flow Analysis - The biopharmaceutical sector saw a net outflow of 2.7582 million from institutional investors, while retail investors experienced a net outflow of 140 million [2] - Notable capital inflows included: - Junshi Biosciences (688180) with a net inflow of 71.7936 million from institutional investors [3] - Sanofi (688336) with a net inflow of 67.508 million from institutional investors [3] - Conversely, significant outflows were observed in: - Sanofi (688336) with a retail net outflow of 540,300 [3] - Rongchang Bio (688331) with a retail net outflow of 4.41034 million [3]

Group 1 - The innovative drug sector is leading the market, with Kangfang Biotech and 3SBio both rising over 8%, contributing to a 3.5% increase in the Hang Seng Innovative Drug ETF (159316) [1] - The Hang Seng Innovative Drug ETF has attracted a total of 849 million in capital over the past 20 days, bringing its latest scale to 2.961 billion [1] - The ETF is the only one tracking the Hang Seng Hong Kong Stock Connect Innovative Drug Index, which has recently been updated to exclude CXO, achieving a "100% purity" in innovative drug representation [1] Group 2 - The innovative drug sector is experiencing a significant upward trend, with attention on domestic innovative drug companies participating in the upcoming ESMO conference in Berlin from October 17 to 21, 2025 [1] - Companies to watch include Kangfang Biotech, Kelun-Biotech, Hengrui Medicine, Rongchang Biotech, Junshi Biosciences, and Jinfang Medicine, particularly for new data releases in dual antibodies and ADC technologies [1] - Huafu Securities expresses optimism about the innovative drug industry, predicting a transformative growth over the next 5-10 years driven by overseas business development, continuous data catalysts, and new product sales expansion [1]

Core Insights - Rongchang Biologics (09995) experienced a 5.10% increase in stock price, currently trading at HKD 95.90, with a transaction volume of HKD 287 million [1] Group 1: Clinical Research Announcement - On October 16, Rongchang Biologics announced the results of its Phase III clinical study for Taitasip in treating systemic lupus erythematosus (SLE), published in the prestigious medical journal New England Journal of Medicine (NEJM) [1] - Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease that can affect multiple organs and lead to irreversible damage, with over half of patients experiencing organ damage within 2-6 years post-diagnosis [1]

Core Viewpoint - The innovation drug sector in China is experiencing significant growth, driven by increased investment, favorable policies, and a strong pipeline of new drugs entering clinical trials, positioning it for a robust future in both domestic and international markets [6][8][10]. Group 1: Market Performance - As of October 16, the Science and Technology Innovation Drug ETF (Huitianfu, 589120) saw a notable increase of 3.31%, maintaining a rise of over 2% despite a slight pullback [1]. - The ETF has attracted over 40 million yuan in net inflows over the past five days, indicating strong investor interest [1]. - Key constituent stocks such as Sangfor Technology and Yifang Bio have shown significant gains, with Sangfor hitting the daily limit up and Yifang Bio rising by 8.61% [2][3]. Group 2: Industry Trends - The number of License-out transactions in China reached 72 in the first half of 2025, surpassing half of the total for 2024, with a total transaction value 16% higher than the previous year [5]. - The innovation drug sector is primarily driven by business development (BD) expectations, with a significant portion of annual BD activity occurring in the fourth quarter [6]. - The Chinese innovation drug market is expected to see a recovery in confidence as more BD deals materialize, particularly as companies prepare for the upcoming European Society for Medical Oncology (ESMO) conference [6][7]. Group 3: R&D and Financial Outlook - Since 2015, Chinese innovation drug companies have significantly increased R&D investments, leading to a rise in the number of original innovative drugs entering clinical trials, with 704 drugs expected to enter Phase I trials in 2024 [8]. - The revenue of innovation drug companies has been steadily increasing, with projections indicating that one-third of these companies will achieve profitability by 2025, and 70% will reach breakeven by 2026 [8]. - The Chinese government's support for innovation drugs through favorable policies and increased funding is expected to enhance the sector's growth, with healthcare spending on innovation drugs projected to rise from 50 billion yuan in 2022 to 120 billion yuan in 2024 [9]. Group 4: Competitive Landscape - The impending patent cliff for multinational corporations (MNCs) is expected to create a demand for new products, with 190 drugs losing patent protection by 2030, including 69 with annual sales exceeding 1 billion dollars [10]. - Chinese innovation drug companies are well-positioned to fill this gap due to their high R&D efficiency and rich technological outcomes, making them attractive partners for MNCs [10].

Core Viewpoint - Rongchang Biopharma's Taitasip showed significant efficacy in treating Sjögren's syndrome in the Phase III trial conducted in China, with the 160mg dosage group demonstrating notable statistical differences and clinical improvements compared to the placebo group [1][3]. Group 1: Clinical Data and Efficacy - The Phase III trial results revealed that 71.8% of patients in the Taitasip group experienced an improvement of 3 or more points in the ESSDAI score, significantly higher than the 19.3% in the placebo group, effectively validating its therapeutic efficacy [3]. - Taitasip outperformed competitors like Novartis' Ianalumab and Johnson & Johnson's Nikalimab in improving patient-reported symptoms, indicating a potential for expanding its use beyond systemic lupus erythematosus to another important autoimmune indication [3]. Group 2: Competitive Advantages of Chinese Innovative Drugs - Chinese innovative drugs have established a differentiated, high-cost performance, and global competitive advantage, with core capabilities evolving from drug design to international compliance [4]. - The domestic pharmaceutical industry has transitioned from "me-too" to "me-better" and "first-in-class" drug development, focusing on unique technical breakthroughs rather than just cost competition [4]. - The cost of developing similar targeted drugs in China is approximately one-third of international levels, supported by a large population providing rich clinical resources and the ongoing release of "engineer dividends" in the biopharmaceutical sector [4]. Group 3: Global Clinical Trial Compliance - Leading Chinese pharmaceutical companies have developed the capability to conduct clinical trials according to ICH standards, allowing their clinical data to be directly used for international drug registration, thus lowering barriers for global commercialization [5]. - The Chinese innovative drug sector has progressed from "catching up" to "keeping pace," with some areas even leading, as evidenced by domestic products outperforming international counterparts in head-to-head clinical trials [5]. Group 4: Investment Opportunities in Innovative Drugs - The innovative drug sector is experiencing volatility, primarily due to market style shifts and short-term capital flows, but remains focused on business development (BD) expectations, with the fourth quarter typically accounting for about 40% of annual BD activity [6]. - The Guotai Innovative Drug ETF (517110) tracks the Shanghai-Hong Kong-Shenzhen innovative drug industry index, covering quality innovative drug companies across various segments, reflecting the overall performance of the innovative drug industry [6].

Core Viewpoint - Rongchang Biologics (09995.HK) experienced a significant increase in stock price, rising over 5% to reach 96.45 HKD with a trading volume of 205 million HKD [2] Company Summary - Rongchang Biologics' stock price increased by 5.7% as of the latest report [2] - The current trading price is 96.45 HKD [2] - The total trading volume reached 205 million HKD [2]