股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年9月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 榮昌生物製藥（煙台）股份有限公司 呈交日期: 2025年10月8日 I. 法定/註冊股本變動 | 2. 股份分類 | 普通股 | | 股份類別 | A | | 於香港聯交所上市 (註1) | 否 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 688331 | 說明 | | 在上海證券交易所上市 | | | | | | | | 已發行股份（不包括庫存股份）數目 | | | 庫存股份數目 | | 已發行股份總數 | | | 上月底結存 | | | | 355,027,004 | | 0 | | 355,027,004 | | 增加 / 減少 (-) | | | | 0 | | 0 | | | | 本月底結存 | | | | 355,027,004 | | 0 | | 355,027,004 | | 1. 股份分類 | 普通股 | 股份類別 | ...

Core Insights - The report from CMB International highlights the release of the first batch of innovative pharmaceutical technology medical insurance payment incentive catalog by Zhejiang Province, which is expected to alleviate the challenges of innovative drugs entering hospitals [1] - Despite the Trump administration's announcement of a 100% tariff on imported innovative drugs, the overall impact on China's pharmaceutical industry chain is considered manageable, with a recommendation to monitor subsequent developments [1] - The upcoming ESMO conference in mid to late October is noted as a key event, with a focus on companies such as CanSino Biologics (09926), Kelun-Biotech (06990), and Rongchang Biologics (688331.SH) that are expected to release significant data [1] Industry Summary - The Hong Kong pharmaceutical sector has shown relatively flat performance in September, but with increasing industry catalysts such as academic conferences and favorable policy implementations in October, a market rebound is anticipated [1] - The report recommends focusing on specific segments: 1) Innovative drugs: Companies like 3SBio (01530) and Eucure Biopharma-B (06996) have rich short-term catalysts and their valuations do not yet reflect the core value of major products; companies like Ascletis Pharma (02096), Hutchison China MediTech (00013), and Legend Biotech are considered significantly undervalued with clear long-term growth logic [1] 2) CXO: Leaders in this segment, such as WuXi AppTec (02268), are expected to benefit from high downstream demand and marginal recovery in financing [1]

Core Viewpoint - The biopharmaceutical sector experienced a slight increase of 0.49% on September 30, with Rongchang Biopharmaceutical leading the gains. The Shanghai Composite Index closed at 3882.78, up 0.52%, while the Shenzhen Component Index closed at 13526.51, up 0.35% [1]. Group 1: Stock Performance - Rongchang Biopharmaceutical (688331) closed at 116.88, with a rise of 6.25% and a trading volume of 85,900 shares, totaling a transaction value of approximately 988.6 million yuan [1]. - Kangbuno (688185) saw a closing price of 79.52, increasing by 2.59% with a trading volume of 16,800 shares, amounting to around 133 million yuan [1]. - Other notable performers included Sanyuan Gene (837344) with a 2.49% increase, closing at 26.74, and Wowo Biopharmaceutical (300357) with a 2.24% rise, closing at 29.19 [1]. Group 2: Capital Flow - The biopharmaceutical sector experienced a net outflow of 31.34 million yuan from institutional investors, while retail investors saw a net outflow of 161 million yuan. Conversely, speculative funds recorded a net inflow of 193 million yuan [2]. - The capital flow data indicates that Junshi Biosciences (688180) had a net inflow of approximately 28.17 million yuan from institutional investors, while it faced a net outflow of 22.59 million yuan from retail investors [3]. - Other companies like Olin Biopharmaceutical (688136) and Wowo Biopharmaceutical (300601) also showed varied capital flows, with Olin experiencing a net inflow of 20.08 million yuan from institutional investors [3].

Core Viewpoint - The A-share market is experiencing a rebound, particularly in the innovative drug sector, with significant inflows into the ETF focused on this area, indicating growing investor confidence and interest in the sector [1][2]. Group 1: Market Performance - As of September 30, the ETF for innovative drugs, Huatai-PineBridge (589120), rose by 2%, marking a potential two-day consecutive increase, with net inflows for two days [1]. - The performance of constituent stocks varied, with companies like BaiLi Tianheng and Rongchang Biologics seeing gains of over 3%, while others like TeBao Biologics experienced a pullback [3]. Group 2: Company Developments - Rongchang Biologics has submitted its innovative ophthalmic drug, RC28, for market approval to treat diabetic macular edema (DME), following a significant agreement with Santen Pharmaceutical for exclusive rights in several Asian markets, valued at 1.295 billion yuan [1]. - At the upcoming ESMO conference in Berlin from October 17 to 21, Rongchang Biologics will present 11 original research results, including a pivotal study on RC48-C016 for treating urothelial carcinoma [1]. Group 3: Industry Trends - The innovative drug sector is at a turning point, with a decade of development leading to a robust ecosystem, and a significant number of overseas licensing deals expected in 2025, which will enhance the valuation of ongoing projects [5]. - The industry is transitioning from a research-driven model to one that emphasizes both research and commercialization, with leading companies poised to enter a profitability phase [5]. - The upcoming ESMO conference and other authoritative academic meetings are anticipated to stimulate business development (BD) events, which have been lacking in recent months [2].

Core Viewpoint - Rongchang Biopharma (09995) has seen a stock price increase of over 7%, currently trading at 118.8 HKD with a transaction volume of 476 million HKD, driven by significant developments in its product pipeline and research achievements [1] Group 1: Product Development - On September 30, the CDE website announced that Rongchang Biopharma's ophthalmic innovative drug, Ilifapru α (RC28), has been submitted for market approval for the treatment of Diabetic Macular Edema (DME) [1] - In August, Rongchang Biopharma entered into an agreement with Santen Pharmaceutical's wholly-owned subsidiary, Santen China, granting exclusive rights for the development, production, and commercialization of Ilifapru α in Greater China and several Southeast Asian countries, with a total transaction value of 1.295 billion CNY [1] Group 2: Research Achievements - Rongchang Biopharma has successfully had 11 original research results selected for presentation at the 2025 European Society for Medical Oncology (ESMO) annual meeting, scheduled from October 17 to 21 in Berlin, Germany [1] - The RC48-C016 phase III clinical study of Vidisichimab in combination therapy for first-line urothelial carcinoma has been selected for the latest breakthrough abstract (LBA), and the company will showcase data across multiple tumor types and treatment strategies, including 2 short oral presentations and 8 poster displays covering urothelial carcinoma, gastric cancer, and gynecological tumors [1]

此外，2025年欧洲肿瘤内科学会(ESMO)年会将于当地时间10月17日至21日在德国柏林召开，荣昌生物 11项原创研究成果成功入选。其中，维迪西妥单抗联合治疗一线尿路上皮癌的RC48-C016Ⅲ期临床研究 入选最新突破摘要(LBA)，公司还将展示10项多个瘤种及相关治疗策略的最新数据，呈现形式包括2项 简短口头报告和8项壁报展示，覆盖尿路上皮癌、胃癌、妇科肿瘤等领域。 荣昌生物(09995)再涨超7%，截至发稿，涨6.07%，报118.8港元，成交额4.76亿港元。 消息面上，9月30日，CDE网站显示，荣昌生物的眼科创新药伊立芙普α(RC28)申报上市，用于治疗糖 尿病黄斑水肿(DME)。据悉，今年8月，荣昌生物与参天制药全资子公司参天中国达成协议，将伊立芙 普α在大中华区及韩国、泰国、越南、新加坡、菲律宾、印度尼西亚及马来西亚的独家开发、生产和商 业化权利授予后者，总交易金额为12.95亿元。 ...

Core Insights - Vor Bio is advancing telitacicept, a novel treatment for autoimmune diseases, with a Phase 3 study in China focusing on primary Sjögren's disease [1][3] - The clinical data will be presented at ACR Convergence 2025, highlighting the efficacy and safety of telitacicept [2] - Telitacicept has already received approvals in China for systemic lupus erythematosus, rheumatoid arthritis, and generalized myasthenia gravis [5] Company Overview - Vor Bio is a clinical-stage biotechnology company dedicated to transforming the treatment landscape for autoimmune diseases [3] - The company is focused on the rapid advancement of telitacicept through clinical development and commercialization [3] Product Information - Telitacicept is a dual-target fusion protein that inhibits BLyS and APRIL, which are crucial for B cell survival, thereby reducing autoreactive B cells and autoantibody production [4] - In a Phase 3 trial for generalized myasthenia gravis, telitacicept showed a placebo-adjusted improvement of 4.83 points in the MG-ADL scale at 24 weeks [4] Disease Context - Sjögren's disease is a chronic autoimmune condition characterized by overactive B cells leading to inflammation and damage to moisture-producing glands [6] - The disease is often underdiagnosed, with significant impacts on patients' quality of life and an elevated risk of lymphoma [7]

Core Insights - Vor Bio is advancing telitacicept for the treatment of autoimmune diseases, with a focus on primary Sjögren's disease, and will present clinical data from a Phase 3 study at ACR Convergence 2025 [1][2] Company Overview - Vor Bio is a clinical-stage biotechnology company dedicated to transforming the treatment of autoimmune diseases, particularly through the development of telitacicept [3] - The company aims to rapidly advance telitacicept through Phase 3 clinical development and commercialization to address serious autoantibody-driven conditions globally [3] Product Information - Telitacicept is a novel investigational recombinant fusion protein that selectively inhibits BLyS (BAFF) and APRIL, two cytokines crucial for B cell and plasma cell survival, thereby reducing autoreactive B cells and autoantibody production [4] - The drug has shown a placebo-adjusted improvement of 4.83 points in the MG-ADL scale at 24 weeks in a Phase 3 trial for generalized myasthenia gravis [4] Regulatory Progress - RemeGen, a collaborator of Vor Bio, announced the acceptance of its Biologics License Application (BLA) for telitacicept for primary Sjögren's disease by the National Medical Products Administration (NMPA) in China, marking its fourth approved indication in the country [2][5] Disease Context - Sjögren's disease is a chronic autoimmune condition characterized by overactive B cells that lead to inflammation and damage to moisture-producing glands, with symptoms including dry eyes, dry mouth, fatigue, and systemic complications [6][7] - The disease is underdiagnosed, with approximately half of the cases unrecognized, and predominantly affects women [7]

Core Viewpoint - Rongchang Biopharma (09995) saw a stock increase of over 7%, reaching 109.4 HKD with a trading volume of 357 million HKD, following the announcement of its drug Taitasip being prioritized for review for treating adult patients with primary immunoglobulin A (IgA) nephropathy, significantly reducing proteinuria levels [1][1][1] Group 1: Drug Development and Clinical Trials - On September 28, the CDE announced that Taitasip is proposed for priority review for treating IgA nephropathy, which poses a risk of progression [1] - On August 27, Rongchang Biopharma reported that the Phase III study of Taitasip for IgA nephropathy achieved its primary endpoint in Stage A, showing a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the placebo group after 39 weeks of treatment [1][1][1] Group 2: Mechanism of Action - Taitasip is currently the only drug that can simultaneously inhibit B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), both of which are significantly elevated in IgA nephropathy patients compared to the normal population, acting as key drivers of the disease [1] - By inhibiting these two factors, Taitasip can reduce B cell proliferation, lower plasma cell counts, and decrease the generation of abnormal immunoglobulins, thereby blocking the deposition of immune complexes and alleviating renal immune inflammatory responses [1][1][1]

Core Viewpoint - Rongchang Biologics (09995) saw a significant stock increase of over 7%, reaching HKD 109.4 with a trading volume of HKD 357 million, following the announcement of its drug Taitasip being prioritized for review for treating adult patients with primary immunoglobulin A (IgA) nephropathy [1] Group 1: Drug Development and Clinical Trials - On September 28, the CDE website indicated that Taitasip is proposed for inclusion as a priority review product for treating adult patients with IgA nephropathy at risk of progression, significantly reducing proteinuria levels [1] - Previously, on August 27, Rongchang Biologics announced that the Phase III study of Taitasip for IgA nephropathy achieved its primary endpoint in Stage A, showing a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the placebo group after 39 weeks of treatment [1] Group 2: Mechanism of Action - Taitasip is currently the only drug that can simultaneously inhibit B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), both of which are significantly elevated in IgA nephropathy patients compared to the normal population, serving as key drivers of the disease [1] - By inhibiting these two factors, Taitasip can reduce B cell proliferation, lower plasma cell counts, and decrease the production of abnormal immunoglobulins, thereby blocking the deposition of immune complexes at the source and alleviating renal immune inflammatory responses [1]