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，並表明概不就因本公告全部或任何部份內容而產生或因依賴該等 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） 自願公告 批准維迪西妥單抗用於治療HER2低表達且 存在肝轉移的乳腺癌適應症上市申請 本公告乃由榮昌生物製藥（煙台）股份有限公司（「本公司」）自願作出。 本公司董事會（「董事會」）欣然宣佈，本公司已收到中國國家藥品監督管理局（「中 國藥監局」）核准簽發的藥品註冊證書。維迪西妥單抗（代號：RC48，商品名：愛 地希®，批准文號：國藥准字S20210017，證書編號：2026S00808）用於治療HER2 低表達且存在肝轉移的乳腺癌的新適應症上市申請獲得批准。這是維迪西妥單抗 在國內獲批的第四項適應症。 於本公告日期，本公司董事會成員包括執行董事王威東先生、房健民博士、 溫慶凱先生及林健先生；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 ...

Core Viewpoint - Rongchang Biopharmaceutical has received approval from the National Medical Products Administration for the new indication of its drug, RC48 (brand name: Aidiqi®), for the treatment of HER2 low-expressing breast cancer with liver metastasis, marking the fourth approved indication for this drug in China [1] Company Summary - RC48 is the first original antibody-drug conjugate (ADC) developed independently by Rongchang Biopharmaceutical [1] - The drug has been approved for four indications: treatment of HER2 overexpressing locally advanced or metastatic gastric cancer, HER2 overexpressing locally advanced or metastatic urothelial carcinoma, HER2 positive with liver metastasis advanced breast cancer, and HER2 low-expressing with liver metastasis breast cancer [1]

| 证券代码：688331 | 证券简称：荣昌生物 | 公告编号：2026-009 | | --- | --- | --- | | 港股代码：09995 | 港股简称：榮昌生物 | | 荣昌生物制药（烟台）股份有限公司 自愿披露关于维迪西妥单抗用于治疗HER2低表达且存在 肝转移的乳腺癌适应症上市申请获得批准的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重 大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，荣昌生物制药（烟台）股份有限公司（以下简称"公司"或"荣昌生物"）收到 国家药品监督管理局核准签发的《药品注册证书》，维迪西妥单抗（代号：RC48，商品 名：爱地希®）用于治疗 HER2 低表达且存在肝转移的乳腺癌的新适应症上市申请获得 批准，这是维迪西妥单抗在国内获批的第四项适应症。现将情况公告如下： 一、 药品基本情况 通用名：注射用维迪西妥单抗 商品名：爱地希® 新获批适应症：本品适用于治疗既往在转移性疾病阶段接受过至少一种系统治疗的， 或在辅助化疗期间或完成辅助化疗之后 12 个月内复发的，不可切除或转移性 HER2 低 表达（IHC 1+或 IHC 2 ...

维迪西妥单抗是荣昌生物自主研发的中国首个原创抗体偶联(ADC)药物，以肿瘤表面的HER2蛋白为靶 点，能精准识别和杀伤肿瘤细胞，在治疗胃癌、尿路上皮癌、乳腺癌等肿瘤的临床试验中均取得了全球 领先的临床数据，是我国首个获得美国FDA、中国药监局突破性疗法双重认定的ADC药物。截至本公 告披露日，该药已相继获批用于治疗HER2过表达局部晚期或转移性胃癌、HER2过表达局部晚期或转移 性尿路上皮癌、HER2阳性且存在肝转移的晚期乳腺癌和HER2低表达且存在肝转移的乳腺癌四个适应 症。 智通财经APP讯，荣昌生物(688331.SH)发布公告，近日，公司收到国家药品监督管理局核准签发的 《药品注册证书》，维迪西妥单抗(代号：RC48，商品名：爱地希®)用于治疗HER2低表达且存在肝转 移的乳腺癌的新适应症上市申请获得批准，这是维迪西妥单抗在国内获批的第四项适应症。 ...

Core Viewpoint - Rongchang Biopharmaceutical (688331.SH) has received approval from the National Medical Products Administration for the new indication of Vidixtimab (RC48, brand name: Aidiqi®) for the treatment of HER2 low-expressing breast cancer with liver metastasis, marking the fourth approved indication for this drug in China [1] Group 1 - The new indication is specifically for adult breast cancer patients who have previously received at least one systemic treatment during the metastatic disease stage or have relapsed within 12 months after adjuvant chemotherapy, and who have unresectable or metastatic HER2 low-expressing (IHC1+ or IHC2+/ISH-) breast cancer with liver metastasis [1]

转自：智通财经 【荣昌生物：维迪西妥单抗新增乳腺癌适应症获批】《科创板日报》23日讯，荣昌生物(688331.SH)公 告称，公司自主研发的注射用维迪西妥单抗(商品名：爱地希®)用于治疗HER2低表达且存在肝转移的乳 腺癌新适应症获国家药监局批准，成为该药在国内获批的第四项适应症。该适应症适用于既往接受过系 统治疗或辅助化疗后12个月内复发的不可切除或转移性HER2低表达成人乳腺癌患者。此次获批基于一 项Ⅲ期临床试验，结果显示其在目标人群中具有良好疗效与安全性。公司提示，药品商业化受政策、市 场及竞争等多重因素影响，存在不确定性。 ...

Core Viewpoint - Rongchang Biopharmaceutical has received approval from the National Medical Products Administration for the registration certificate of Vidisicimab (brand name: Aidiqi) for a new indication to treat HER2 low-expressing breast cancer with liver metastasis [1] Group 1 - Vidisicimab is now approved for its fourth indication in China [1] - The drug is indicated for adult patients with unresectable or metastatic HER2 low-expressing breast cancer (IHC 1+ or IHC 2+/ISH-) who have previously received at least one systemic treatment during the metastatic disease stage or have relapsed within 12 months after adjuvant chemotherapy [1]

Group 1 - The Hong Kong pharmaceutical sector is experiencing a rebound, with the Hong Kong Stock Connect Innovation Drug ETF (159570) rising nearly 2% and achieving a trading volume exceeding 2.05 billion yuan, leading its peers with a total scale of over 22.8 billion yuan [1] - The 2026 European Association of Urology (EAU) annual meeting held in London showcased innovative applications of HER2-targeted antibody-drug conjugates (ADCs) in treating urothelial carcinoma, with multiple cutting-edge research results from China presented [3] - Rongchang Biopharmaceutical recently reported a revenue of 3.251 billion yuan, a year-on-year increase of 89.36%, and a net profit of 709 million yuan, marking a turnaround from losses, primarily driven by increased sales of its injectable drugs [3] Group 2 - The Hong Kong Stock Connect Innovation Drug ETF (159570) saw most of its constituent stocks perform positively, with Rongchang Biopharmaceutical up over 6%, Kangzhi Pharmaceutical up over 5%, and China Biopharmaceutical up over 3% [3] - Recent approvals for new drugs and indications in China include: 1) Hengrui Medicine's oral new drug for a new indication; 2) Roche's CD79B ADC new indication approved in China; 3) Kangzhi Pharmaceutical's new drug for renal anemia approved; 4) Junshi Biosciences' first domestic PD-1 subcutaneous formulation submitted for approval [6] - The innovative drug sector in China is transitioning from "fast following" to "innovation leading," with significant advancements in new technology platforms such as molecular glue, small nucleic acids, and in vivo CART, which are expected to enhance drug development efficiency and cost-effectiveness [7][8][9] Group 3 - The recent policy shift designating the biopharmaceutical industry as an emerging pillar industry is expected to release a series of policy dividends, indicating a positive outlook for the sector [11] - The Hong Kong Stock Connect Innovation Drug ETF (159570) is fully invested in innovative drugs, with the top ten constituent stocks accounting for 73.54% of its weight, highlighting its focus on the innovation drug sector [12]

Core Viewpoint - Rongchang Biologics (09995) has seen a significant stock increase, attributed to positive developments in the treatment of urothelial carcinoma and strong financial performance [1] Group 1: Stock Performance - Rongchang Biologics' stock rose nearly 8%, with a current price of 96.8 HKD and a trading volume of 238 million HKD [1] Group 2: Industry Developments - The 2026 European Association of Urology (EAU) annual meeting is taking place in London from March 13 to 16, showcasing innovative applications of HER2-targeted antibody-drug conjugate (ADC) Vidisizumab in urothelial carcinoma treatment [1] - Multiple cutting-edge research results from China are being presented, covering the entire disease spectrum from early to late stages and from bladder cancer to upper urinary tract urothelial carcinoma, providing strong new evidence for precision and organ-preserving treatments [1] Group 3: Financial Performance - Rongchang Biologics recently released a performance report indicating a revenue of 3.251 billion RMB, a year-on-year increase of 89.36% [1] - The company reported a net profit attributable to shareholders of 709 million RMB, marking a turnaround from losses [1] - Revenue growth is primarily driven by increased sales of injectable Taitasip and Vidisizumab, along with significant technology licensing income from granting Vor Biopharma Inc. exclusive global development and commercialization rights for Taitasip outside Greater China [1]

Core Viewpoint - Rongchang Biopharma (09995) has seen a significant stock price increase, attributed to positive developments in its product pipeline and strong financial performance [1] Group 1: Stock Performance - Rongchang Biopharma's stock rose nearly 8%, with a current price of 96.8 HKD and a trading volume of 238 million HKD [1] Group 2: Industry Developments - The 2026 European Association of Urology (EAU) annual meeting is taking place in London from March 13 to 16, showcasing innovative applications of HER2-targeted antibody-drug conjugate (ADC) Vidisitamab in the treatment of urothelial carcinoma [1] - Multiple cutting-edge research results from China were presented, covering the entire disease spectrum from early to late stages, including bladder cancer and upper urinary tract urothelial carcinoma, providing strong new evidence for precision and organ-preserving treatments [1] Group 3: Financial Performance - Rongchang Biopharma reported a revenue of 3.251 billion RMB, a year-on-year increase of 89.36% [1] - The company achieved a net profit attributable to shareholders of 709 million RMB, marking a turnaround from losses [1] - Revenue growth is primarily driven by increased sales of injectable Taitasip and injectable Vidisitamab, along with significant technology licensing income from granting Vor Biopharma Inc. exclusive global development and commercialization rights outside Greater China [1]