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].

此次被CDE纳入突破性治疗药物品种，基于RC148一项在中国开展的多中心、开放性I/II期临床研究 (RC148-C001)。该临床研究包括探索RC148联合多西他赛治疗既往经PD-1/PD-L1抑制剂和含铂化疗(联 合或续贯)治疗失败的NSCLC的疗效和安全性，主要终点为客观缓解率(ORR)等。研究结果显示，在经 PD-1/PD-L1抑制剂和含铂化疗(联合或续贯)治疗失败的晚期NSCLC患者中，RC148联合多西他赛展现出 相比同类药物或者标准治疗更加优异的疗效，且联合治疗安全性可控，耐受良好，有望为该人群提供新 的治疗选择。 突破性治疗药物是指用于防治严重危及生命或者严重影响生存质量的疾病，且尚无有效防治手段，或者 与现有治疗手段相比有足够证据表明具有明显临床优势的创新药或改良型药物。对纳入突破性治疗药物 的创新药，CDE将优先配置资源，新药上市时间将大大缩短。本次被纳入突破性治疗品种认定，彰显了 RC148巨大的临床价值和开发潜力，将有助于加速RC148的临床开发进程，更快惠及广大患者。 格隆汇8月19日丨荣昌生物(09995.HK)发布公告，公司原研的新型双特异性抗体RC148被中国国家药品 监督管理 ...

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].