据介绍，本次大会上，荣昌生物的多项重磅研究成果将集中亮相。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(Late-Breaking Abstracts，LBA)"，展现了该研 究的重要学术价值。此外，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，全面体现荣昌生物在ADC药 物联合治疗中的领先实力。 消息面上，据荣昌生物官微消息，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，其中多项临床研究数据为首次在国际公布。 荣昌生物(09995)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。 ...

智通财经APP获悉，荣昌生物(09995)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。 据介绍，本次大会上，荣昌生物的多项重磅研究成果将集中亮相。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(Late-Breaking Abstracts，LBA)"，展现了该研 究的重要学术价值。此外，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，全面体现荣昌生物在ADC药 物联合治疗中的领先实力。 消息面上，据荣昌生物官微消息，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，其中多项临床研究数据为首次在国际公布。 ...

Company Overview - Rongchang Biopharmaceuticals is an innovative biopharmaceutical company based in Yantai, Shandong, China, established on July 4, 2008, and listed on March 31, 2022. The company focuses on antibody-drug conjugates (ADC), antibody fusion proteins, monoclonal antibodies, and bispecific antibodies [1] - The company aims to discover, develop, and commercialize innovative first-in-class and best-in-class biopharmaceuticals to address significant unmet clinical needs in autoimmune diseases, oncology, and ophthalmology [1] - The main revenue sources for the company are product sales (99.46%), material sales (0.38%), and leasing services (0.16%) [1] Market Performance - On September 19, Rongchang Biopharmaceuticals' stock fell by 5.02%, trading at 99.35 CNY per share, with a total transaction volume of 659 million CNY and a turnover rate of 3.98%. The company's total market capitalization is approximately 55.994 billion CNY [1] Fund Holdings - According to data, one fund under Jiashi Fund holds a significant position in Rongchang Biopharmaceuticals. Jiashi Xinhe One-Year Holding Period Mixed A (008664) held 14,900 shares in the second quarter, accounting for 0.38% of the fund's net value, ranking as the eighth-largest holding [2] - The fund has experienced a floating loss of approximately 78,200 CNY today [2] Fund Manager Profile - The fund manager of Jiashi Xinhe One-Year Holding Period Mixed A is Yang Yechao, who has been in the position for 9 years and 300 days. The total asset size of the fund is 1.878 billion CNY, with the best fund return during his tenure being 40.38% and the worst being -4.07% [3]

Core Viewpoint - Rongchang Biologics (09995) saw a stock increase of over 8%, currently trading at 115 HKD with a transaction volume of 222 million HKD, following the announcement of positive clinical trial data for its innovative drug, Tai Ai (RC18) [1] Group 1: Clinical Development - On September 18, Rongchang Biologics announced that its self-developed dual-target fusion protein drug, Tai Ai (RC18), has successfully entered the 2025 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) annual meeting for a verbal presentation, showcasing data from a 48-week open-label extension study aimed at verifying long-term efficacy for generalized myasthenia gravis (gMG) [1] - The AANEM annual meeting will take place from October 29 to November 1, 2025, in San Francisco, California [1] Group 2: Strategic Partnerships - Recently, during an earnings briefing, the company revealed that in August 2021, it entered into a global exclusive licensing agreement with Seattle Genetics (now acquired by Pfizer Inc.) for the development and commercialization rights of Vidisicimab (RC48) outside of its designated regions, which exclude Japan and Singapore [1] - Currently, the clinical trials for RC48 are being advanced as planned by Pfizer in overseas markets [1]

Core Viewpoint - The Hong Kong Stock Connect Innovation Drug ETF (520880) has shown a rebound, indicating strong buying interest in innovative drug companies, with significant trading volume and price increases among key constituents [1][3]. Group 1: Market Performance - The Hong Kong Stock Connect Innovation Drug ETF (520880) experienced a price increase of over 2% shortly after market opening, with trading volume exceeding 1 billion yuan within 20 minutes [1]. - The ETF has been trading at a premium, reflecting strong demand, and has attracted capital for 12 consecutive days [3]. - The ETF's index has achieved a year-to-date increase of 119.75%, outperforming other innovative drug indices [4]. Group 2: Policy and Industry Developments - The National Medical Products Administration has introduced a "30-day review and approval channel" for clinical trial applications of qualifying innovative drugs, aimed at accelerating drug development [3]. - The industry is witnessing significant changes in seven innovative drug sectors, including next-generation IO, weight loss, small nucleic acids, and others, which are expected to create substantial market opportunities [3]. Group 3: Financial Performance - The Hong Kong innovative drug sector reported a net profit of 1.8 billion yuan in the first half of the year, marking a turnaround from losses to profitability [3]. - The innovative drug industry is entering a new cycle driven by profitability, indicating a clear inflection point in the fundamentals [3]. Group 4: ETF Composition Changes - The ETF has undergone a "purification" revision, removing CXO companies and focusing solely on 14 innovative drug research and development firms, enhancing its representation of the sector [4]. - The ETF is the largest and most liquid among its peers, with a fund size exceeding 1.7 billion yuan and an average daily trading volume of 521 million yuan since its inception [5].

Core Insights - Rongchang Biopharma (09995) shares rose over 8%, reaching HKD 115 with a trading volume of HKD 222 million [1] Group 1: Clinical Development - On September 18, Rongchang Biopharma announced that its self-developed innovative drug, RC18 (brand name: Tai'ai®), targeting both BLyS and APRIL, has successfully completed a 48-week open-label extension study for the treatment of generalized Myasthenia Gravis (gMG) [1] - The long-term efficacy data from this study has been selected for an oral presentation at the 2025 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) annual meeting, scheduled for October 29 to November 1 in San Francisco, California [1] Group 2: Strategic Partnerships - Rongchang Biopharma disclosed during its earnings briefing that in August 2021, it entered into a global exclusive licensing agreement with Seattle Genetics (now acquired by Pfizer Inc.) for the global development and commercialization rights of RC48 outside of its region (excluding Japan and Singapore) [1] - Currently, the clinical trials for RC48 are being advanced as planned by Pfizer in overseas markets [1]

Core Viewpoint - Rongchang Biopharma (688331.SH) has established a global exclusive licensing agreement with Seattle Genetics (now acquired by Pfizer Inc.) for the development and commercialization rights of RC48 outside of Japan and Singapore, with ongoing clinical trials being conducted by Pfizer as planned [1] Group 1 - The company is actively collaborating with Pfizer to support clinical development and regulatory submissions in overseas markets [1] - Key challenges in the internationalization process include regulatory differences across countries, complex market access policies, and dynamic competitive environments [1]

Company Overview - Rongchang Biopharmaceuticals is an innovative biopharmaceutical company based in Yantai, Shandong, China, established on July 4, 2008, and listed on March 31, 2022 [2] - The company focuses on the development and commercialization of therapeutic antibody drugs, including antibody-drug conjugates (ADC), fusion proteins, and monoclonal antibodies, targeting significant diseases such as autoimmune diseases, tumors, and ocular diseases [2] - The main revenue sources are from product sales (99.46%), with minor contributions from material sales (0.38%) and leasing services (0.16%) [2] Financial Performance - For the first half of 2025, Rongchang Biopharmaceuticals reported a revenue of 1.098 billion yuan, representing a year-on-year growth of 48.02% [3] - The net profit attributable to the parent company was -450 million yuan, showing a year-on-year increase of 42.40% [3] Stock Performance - As of September 12, the stock price of Rongchang Biopharmaceuticals was 107.95 yuan per share, with a year-to-date increase of 258.52% [1] - The stock has seen a 17.12% increase over the last five trading days, a 40.21% increase over the last 20 days, and a 71.84% increase over the last 60 days [1] - The company has appeared on the "Dragon and Tiger List" four times this year, with the most recent appearance on June 26, where it recorded a net buy of -137 million yuan [1] Shareholder Structure - As of June 30, 2025, the number of shareholders increased to 12,900, a rise of 90.69% [3] - The average number of circulating shares per shareholder decreased by 47.56% to 12,595 shares [3] - Notable new institutional shareholders include Hong Kong Central Clearing Limited and several mutual funds, indicating growing institutional interest [4]

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 for the company are 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 108.37 CNY per share, with a trading volume of 1.022 billion CNY and a turnover rate of 6.32%, leading to a total market capitalization of 61.078 billion CNY [1] Fund Holdings - The Huatai-PB Fund holds a significant position in Rongchang Biopharmaceuticals, with its Huatai-PB SSE STAR Market Comprehensive ETF Linked A (023741) being the largest shareholder, owning 627 shares, which constitutes 0.02% of the fund's net value [2] - The fund has achieved a return of 27.55% since its inception on April 18, 2025 [2] Fund Manager Information - The fund manager of Huatai-PB SSE STAR Market Comprehensive ETF Linked A is Tan Hongxiang, who has been in the position for 4 years and 187 days, managing a total asset size of 27.342 billion CNY [3] - During his tenure, the best fund return was 78.18%, while the worst return was -37.2% [3]

华泰联合证券有限责任公司 关于荣昌生物制药（烟台）股份有限公司 2025 年半年度持续督导跟踪报告 | 保荐机构名称：华泰联合证券有限责任公司 | 被保荐公司简称：荣昌生物 | | --- | --- | | 保荐代表人姓名：刘兆明 | 联系电话：025-56839300 | | 保荐代表人姓名：高元 | 联系电话：025-83387686 | 根据《中华人民共和国证券法》《证券发行上市保荐业务管理办法》和《上 海证券交易所科创板股票上市规则》（以下简称"《上市规则》"）等有关法律、 法规的规定，华泰联合证券有限责任公司（以下简称"华泰联合证券"或"保荐 机构"）作为荣昌生物制药（烟台）股份有限公司（以下简称"荣昌生物"、"公 司"或"发行人"）首次公开发行股票的保荐机构，对荣昌生物进行持续督导， 并出具本持续督导跟踪报告： 一、保荐机构和保荐代表人发现的问题及整改情况 （一）发现的问题 2025年上半年，公司实现营业收入10.98亿元，较去年同期的7.42亿元增加 48.02%，主要是因为两个核心产品泰爱®（泰它西普）、爱地希®（维迪西妥单抗） 销售收入及销量同比快速增长。归属于上市公司股东的净亏损4.50 ...