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 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]

每经AI快讯，9月29日，港股荣昌生物(09995.HK)涨超7%，截至发稿，涨7.25%，报109.4港元，成交额 3.57亿港元。 ...

Core Viewpoint - Rongchang Biologics (09995) saw a stock increase of over 7%, reaching HKD 109.4 with a trading volume of HKD 357 million, following the announcement of its drug Taizhisip being prioritized for review for treating adult patients with primary immunoglobulin A (IgA) nephropathy [1] Company Developments - On September 28, the CDE announced that Rongchang Biologics' Taizhisip is proposed for inclusion in the priority review category for treating adult patients with IgA nephropathy at risk of progression, significantly reducing proteinuria levels [1] - On August 27, Rongchang Biologics reported that the Phase III study of Taizhisip for treating 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] Drug Mechanism - Taizhisip 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, Taizhisip can reduce B cell proliferation, lower plasma cell counts, and decrease abnormal immunoglobulin production, thereby blocking the deposition of immune complexes and alleviating renal immune inflammatory responses [1]

Core Viewpoint - Rongchang Biologics (09995) saw a stock increase of over 7%, currently at 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 [1] Group 1: Drug Development and Clinical Trials - On September 28, the CDE website indicated that Taitasip is proposed for inclusion in the priority review category for treating adult patients with IgA nephropathy at risk of progression, significantly reducing proteinuria levels [1] - On August 27, Rongchang Biologics announced that the Phase III study of Taitasip for treating 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 generation of abnormal immunoglobulins, thereby blocking the deposition of immune complexes at the source and alleviating renal immune inflammatory responses [1]

Financial Performance - Revenue for the six months ended June 30, 2025, reached RMB 1,091,976 thousand, a significant increase of 47.6% from RMB 739,656 thousand in the same period of 2024[9]. - Gross profit for the first half of 2025 was RMB 921,848 thousand, up 61.5% from RMB 570,385 thousand in the prior year[9]. - RemeGen's pre-tax loss for the first half of 2025 was RMB 449,568 thousand, an improvement from a loss of RMB 780,460 thousand in the same period of 2024[9]. - The net loss for the period was RMB 449,568 thousand, an improvement from a net loss of RMB 780,460 thousand in the prior year, showing a 42.4% reduction in losses[132]. - The basic loss per share improved to RMB (0.83) from RMB (1.45) year-over-year, indicating better performance on a per-share basis[132]. - The total comprehensive loss for the period was RMB 419,557 thousand, which includes other comprehensive income of RMB 29,011 thousand[138]. Assets and Liabilities - Total assets increased to RMB 5,850,358 thousand as of June 30, 2025, compared to RMB 5,498,519 thousand as of December 31, 2024, reflecting a growth of approximately 6.4%[9]. - The total liabilities as of June 30, 2025, were RMB 3,492,867 thousand, a slight decrease from RMB 3,512,318 thousand as of December 31, 2024[9]. - The total equity increased to RMB 2,357,491 thousand as of June 30, 2025, compared to RMB 1,986,201 thousand as of December 31, 2024, representing a growth of approximately 18.6%[9]. - Cash and cash equivalents increased significantly to RMB 1,271,002 thousand from RMB 759,530 thousand, representing a 67.3% increase[135]. - The group's debt-to-asset ratio improved from 63.9% as of December 31, 2024, to 59.7% as of June 30, 2025[58]. Research and Development - Research and development expenses decreased to RMB 647,216 thousand in the first half of 2025 from RMB 806,233 thousand in the same period of 2024, indicating a reduction of approximately 19.7%[9]. - The company has developed over ten drug candidates, with seven currently in clinical development targeting more than twenty indications[10]. - The company is developing a rich pipeline of candidates, including Taitasip for various autoimmune diseases and other indications[14]. - The company is actively exploring additional indications for Taitasip, planning to initiate multiple Phase II/III clinical trials domestically[19]. Clinical Trials and Product Development - The company initiated a Phase III clinical trial for Taitasip (RC18) in China for the treatment of generalized myasthenia gravis (gMG) in the first half of 2023, with the trial expected to reach its primary endpoint by August 2024[15]. - In the Phase III trial, Taitasip demonstrated a significant reduction in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score by 5.74 points compared to a 0.91 point reduction in the placebo group, with 98.1% of patients showing improvement of ≥3 points[16]. - A licensing agreement was established with Vor Biopharma Inc. for the development and commercialization of Taitasip outside Greater China, with a total value of $125 million, including an upfront payment of $45 million[19]. - Vor Biopharma is conducting a global Phase III clinical trial for Taitasip in gMG patients, having received orphan drug designation from the FDA in October 2022[20]. - The company has developed Vidisicimab, a leading antibody-drug conjugate (ADC) candidate, which is the first domestically approved ADC in China for treating HER2-expressing solid tumors, including low-expressing types[22]. Market and Sales - The company has commercialized two products, RC18 (brand name: Tai'ai®) and RC48 (brand name: Aidiqi®), which are undergoing clinical trials in China and the United States for over twenty indications[10]. - The company aims to become a leading player in the global biopharmaceutical industry, focusing on innovative and differentiated biologics for unmet medical needs[10]. - Revenue increased from RMB 739.7 million for the six months ended June 30, 2024, to RMB 1,092.0 million for the six months ended June 30, 2025, driven by strong sales of the autoimmune product Taitasip and the oncology product Vidisizumab[42]. Shareholder and Equity Information - As of June 30, 2025, the company had a total of 563,608,243 shares, including 208,581,239 H-shares and 355,027,004 A-shares[75]. - Mr. Wang Weidong holds a 43.25% equity interest in A-shares through controlled entities, representing 27.24% of the total shares[71]. - The company has established a consortium agreement among key stakeholders to ensure unified action in management and decision-making[73]. - The company issued 54,426,301 new A-shares at RMB 48.00 per share, raising approximately RMB 2,612.4 million, with net proceeds of about RMB 2,505.9 million after deducting issuance costs[68]. Incentive Plans - The company has implemented the first H-share plan to enhance its compensation system and ensure a balance of interests among stakeholders[82]. - The second phase of the H-share plan allows for the purchase of up to 27,213,150 H-shares, representing approximately 13.05% of the total issued H-shares and about 4.83% of the total share capital as of the report date[96]. - The 2022 A-share plan aims to enhance the company's long-term incentive mechanism, attracting and retaining talent while aligning the interests of shareholders, the company, and core team members[105]. - The maximum number of shares that any incentive recipient can receive will not exceed 1% of the total shares as of the announcement date[105]. Corporate Governance - The company has complied with all applicable corporate governance codes as of June 30, 2025[122]. - The independent auditor has reviewed the interim financial information in accordance with the relevant standards, confirming compliance with applicable accounting standards and regulations[124].

每经AI快讯，9月25日，港股荣昌生物(09995.HK)早盘涨超5%，截至发稿，涨5.54%，报108.6港元，成 交额1.1亿港元。 （文章来源：每日经济新闻） ...

Core Viewpoint - Rongchang Biopharmaceuticals has shown a significant increase in stock price, reflecting positive market sentiment and investor interest in its innovative biopharmaceutical products [1] Company Overview - Rongchang Biopharmaceuticals, established on July 4, 2008, and listed on March 31, 2022, is located in the Yantai Free Trade Zone, Shandong, China [1] - The company focuses on the development and commercialization of innovative biopharmaceuticals, particularly in the fields of antibody-drug conjugates (ADC), antibody fusion proteins, monoclonal antibodies, and bispecific antibodies [1] - The main revenue sources are from product sales (99.46%), material sales (0.38%), and leasing services (0.16%) [1] Financial Performance - As of the report date, Rongchang Biopharmaceuticals' stock price is 110.17 CNY per share, with a market capitalization of 62.093 billion CNY and a trading volume of 2.19 billion CNY [1] Fund Holdings - Jiahe Fund has a significant holding in Rongchang Biopharmaceuticals through its Jiahe Jinpeng Tianli Mixed A fund, which held 200,000 shares, accounting for 1.69% of the fund's net value [2] - The fund has generated a floating profit of approximately 1.054 million CNY from this investment [2] Fund Manager Information - The fund managers of Jiahe Jinpeng Tianli Mixed A are Yu Qiming and Ji Huijuan, with respective tenures of 13 years and 10 years [3] - The fund has a total asset scale of 156.9 billion CNY and 206.49 billion CNY, with historical best returns of 48.33% and 38.43% respectively [3]