智通财经APP讯，恒瑞医药(01276)发布公告，近日,江苏恒瑞医药股份有限公司(以下简称"公司")子公司 山东盛迪医药有限公司的HRS-5346片被国家药品监督管理局药品审评中心(以下简称"药审中心")纳入突 破性治疗品种名单。 根据《国家药监局关于发布<突破性治疗药物审评工作程序(试行)>等三个文件的公告》(2020年第82 号)，药审中心对纳入突破性治疗药物程序的药物优先配置资源进行沟通交流，加强指导并促进药物研 发。药品研发容易受到技术、审批、政策等多方面因素的影响，审评政策及未来药品市场竞争形势等存 在诸多不确定性风险。 脂蛋白(a)[Lp(a)]水平升高是全球最普遍的单基因脂质疾病，是脂蛋白紊乱的典型表现之一。中国成年人 的Lp(a)水平>30mg/dL和50mg/dL的患病率分别为 18.67%和8.41% 。高Lp(a)已被证实为动脉粥样硬化性 心血管疾病包括冠心病、缺血性脑卒中、外围血管疾病及钙化性主动脉瓣狭窄等疾病的独立危险因素 [2]。靶向 Lp(a)的降脂疗法是心血管疾病防治的重要突破方向之一。HRS-5346是一种Lp(a)口服小分子 抑制剂，经查询，目前国内外尚无同类产品获批上市。 ...

Core Viewpoint - Fosun Pharma's subsidiary has developed a novel drug, Sruvulimab injection, for the treatment of gastric cancer, which has been included in the breakthrough therapy designation program, potentially accelerating its review and market entry [1] Group 1: Drug Development and Approval - Sruvulimab injection is being used in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer [1] - As of November 20, 2025, the drug has received approval in multiple countries/regions, with several combination therapies currently undergoing clinical trials [1] - The total R&D investment in the drug has reached approximately 3.495 billion yuan as of October 2025 [1] Group 2: Market Potential - There are currently no approved PD-1 targeted monoclonal antibodies for neoadjuvant/adjuvant treatment of gastric cancer globally [1] - The global sales for such drugs are projected to be approximately 45.704 billion USD in 2024 [1] - The inclusion in the breakthrough therapy program is expected to expedite the drug's review and market entry, although uncertainties remain regarding the new drug's launch [1]

Group 1 - The core viewpoint of the news is that Rongchang Biopharmaceutical has received a breakthrough therapy designation from the China National Medical Products Administration (NMPA) for its innovative bispecific antibody RC148, aimed at treating non-small cell lung cancer (NSCLC) [1][2] - RC148 is specifically indicated for use in combination with docetaxel for patients with locally advanced or metastatic NSCLC who have failed prior treatment with PD-1/PD-L1 inhibitors and platinum-based chemotherapy [1] - The designation is based on a multicenter, open-label Phase I/II clinical study (RC148-C001) conducted in China, which demonstrated superior efficacy and manageable safety of RC148 combined with docetaxel compared to similar drugs or standard treatments in patients with advanced NSCLC [1] Group 2 - Breakthrough therapy drugs are defined as innovative or modified drugs that are used to treat serious life-threatening diseases with no effective treatment options or those that show significant clinical advantages over existing therapies [2] - The inclusion of RC148 in the breakthrough therapy category highlights its substantial clinical value and development potential, which will facilitate faster clinical development and quicker access for patients [2]

Core Viewpoint - Rongchang Biopharmaceutical has received a breakthrough therapy designation from the China National Medical Products Administration (NMPA) for its innovative bispecific antibody RC148, aimed at treating non-small cell lung cancer (NSCLC) [1][2]. Group 1: Breakthrough Therapy Designation - The bispecific antibody RC148 has been officially included in the list of breakthrough therapies by the NMPA, targeting the indication of RC148 in combination with docetaxel for patients who have previously failed PD-1/PD-L1 inhibitors [2]. - The designation is based on a multicenter, open-label Phase I/II clinical study (RC148-C001) conducted in China, which demonstrated superior efficacy of RC148 combined with docetaxel compared to similar drugs or standard treatments in advanced NSCLC patients who failed prior treatments [2]. Group 2: Clinical Value and Development Potential - The breakthrough therapy designation signifies the significant clinical value and development potential of RC148, which will facilitate accelerated clinical development and resource allocation by the NMPA [2]. - Breakthrough therapies are defined as innovative drugs or modified drugs that provide substantial clinical advantages over existing treatment methods for serious or life-threatening diseases, where no effective treatment options are available [2].

Group 1 - The core point of the news is that Rongchang Biologics' new bispecific antibody RC148 has been officially included in the list of breakthrough therapy drugs by the CDE, targeting locally advanced or metastatic non-small cell lung cancer (NSCLC) that has failed previous treatments [1][2] - The inclusion is based on a multicenter, open-label Phase I/II clinical study (RC148-C001) conducted in China, which evaluates the efficacy and safety of RC148 in combination with docetaxel for NSCLC patients who have failed PD-1/PD-L1 inhibitors and platinum-based chemotherapy [1] - The study results indicate that RC148 combined with docetaxel shows superior efficacy compared to similar drugs or standard treatments, with manageable safety and good tolerability, potentially providing a new treatment option for this patient population [1] Group 2 - Breakthrough therapy drugs are defined as innovative or modified drugs used to treat serious life-threatening diseases with no effective treatment options or those that demonstrate significant clinical advantages over existing therapies [2] - The inclusion of RC148 as a breakthrough therapy highlights its substantial clinical value and development potential, which will help accelerate its clinical development process and benefit a larger patient population more quickly [2]

Core Insights - Rongchang Biopharma's novel bispecific antibody RC148 has been officially included in the list of breakthrough therapy drugs by the Center for Drug Evaluation (CDE) in China, targeting locally advanced or metastatic non-small cell lung cancer (NSCLC) that has failed previous treatments [1][2] - The inclusion is based on a multicenter, open-label Phase I/II clinical study (RC148-C001) demonstrating superior efficacy and manageable safety of RC148 combined with docetaxel compared to standard treatments in patients with treatment-resistant NSCLC [1] Group 1: Breakthrough Therapy Designation - Breakthrough therapy drugs are defined as innovative or modified drugs used to treat serious or life-threatening diseases with no effective treatment options or those showing significant clinical advantages over existing therapies [2] - The CDE will prioritize resources for drugs designated as breakthrough therapies, significantly shortening the time to market for new drugs [2] Group 2: Clinical Study Results - The primary endpoint of the clinical study was the objective response rate (ORR), which indicated that RC148 combined with docetaxel showed better efficacy than similar drugs or standard treatments in patients who had previously failed PD-1/PD-L1 inhibitors and platinum-based chemotherapy [1] - The safety profile of the combination treatment was reported to be controllable and well-tolerated, suggesting a new treatment option for this patient population [1]

Core Insights - Rongchang Biopharma's novel bispecific antibody RC148 has been officially included in the list of breakthrough therapy drugs by the China National Medical Products Administration (NMPA) [1][2] - The indication for RC148 is for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that has failed prior PD-1/PD-L1 inhibitors and platinum-based chemotherapy [1] - The inclusion is based on a multicenter, open-label Phase I/II clinical study (RC148-C001) demonstrating superior efficacy and manageable safety compared to similar drugs or standard treatments [1] Group 1 - RC148's inclusion as a breakthrough therapy highlights its significant clinical value and development potential [2] - The drug aims to provide a new treatment option for patients with advanced NSCLC who have limited alternatives [1][2] - The NMPA's designation will expedite the clinical development process and potentially shorten the time to market for RC148 [2] Group 2 - Breakthrough therapy drugs are defined as innovative or modified drugs that address serious or life-threatening diseases with no effective treatment options or demonstrate significant clinical advantages over existing therapies [2] - The NMPA will prioritize resource allocation for drugs recognized as breakthrough therapies, facilitating faster access for patients [2]

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之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或因倚 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） 自願公告 中國國家藥品監督管理局藥品審評中心(CDE)授予RC148突破性治療 藥物認定用於治療非小細胞肺癌(NSCLC) 本公告由榮昌生物製藥（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，本公司原研的新型雙特異性抗體RC148被中 國國家藥品監督管理局藥品審評中心(CDE)正式納入突破性治療藥物品種，針對 適應症為：RC148聯合多西他賽治療經PD-1/PD-L1抑制劑和含鉑化療（聯合或序 貫）治療失敗的驅動基因陰性局部晚期或轉移性非小細胞肺癌(NSCLC)。 此次被CDE納入突破性治療藥物品種，基於RC148一項在中國開展的多中心、開 放性I/II期臨床研究(RC148-C001)。該臨床研究包括探索 ...

Core Viewpoint - The announcement of the inclusion of ABSK011 (Ipagotinib) as a breakthrough therapy for advanced hepatocellular carcinoma (HCC) patients who have failed previous treatments marks a significant milestone for the company, indicating its potential to become a "billion-dollar molecule" [1][2][3]. Group 1: Breakthrough Therapy Designation - ABSK011 has been officially designated as a breakthrough therapy for treating FGF19 overexpressing advanced HCC patients who have previously undergone immune checkpoint inhibitors (ICI) and multi-targeted tyrosine kinase inhibitors (mTKI) [1][2]. - This designation follows the earlier approval of Pimicotinib (ABSK021), making ABSK011 the second major product of the company to receive such recognition [1]. Group 2: Clinical Data and Efficacy - Recent clinical data presented at the ESMO conference showed that the 220mg BID dosage of ABSK011 achieved an overall response rate (ORR) of 44.8% in patients with FGF19 overexpressing HCC who had previously been treated with ICIs and mTKIs [3][4]. - The drug demonstrated a median duration of response (mDOR) of 7.4 months and a median progression-free survival (mPFS) of 5.5 months, significantly outperforming existing therapies [3][4]. Group 3: Market Potential and Competitive Advantage - The global liver cancer market is projected to reach approximately $5.3 billion by 2029, with immunotherapy accounting for about 72.2% of the market share [6]. - The company has developed ABSK011 as the first small molecule inhibitor targeting the aberrant activation of the FGF19/FGFR4 signaling pathway, which is expected to provide a differentiated treatment option for HCC patients [2][6]. Group 4: Financial Performance and Investment Value - The company has achieved its first full-year profitability in 2024, generating substantial cash flow and signaling a sustainable growth trajectory [8]. - The management has been actively repurchasing shares, reflecting confidence in the company's future and commitment to returning value to investors [8][9]. Group 5: Stock Market Performance - Following a period of volatility, the company's stock price rebounded significantly, reaching a peak of 8.95 HKD, with a maximum increase of 62.14% over a one-and-a-half-month period [11]. - This price recovery indicates strong market interest and confidence in the company's fundamentals and growth potential [11].