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荣昌生物涨超3% 自研RC148实现双路径突破 机构看好后续临床潜力
Zhi Tong Cai Jing· 2025-12-23 02:11
该行表示,基于RC148-C001研究的早期数据,2025年8月,RC148联合多西他赛治疗经PD-1/PD-L1抑制 剂和含铂化疗(联合或序贯)治疗失败的驱动基因阴性局部晚期或转移性非小细胞肺癌适应症已获得中国 突破性治疗药物资格认定(BTD)。目前公司正在积极推进相关临床:根据公司投资者调研纪要,RC148 联合治疗一线非小细胞肺癌的II期临床试验已完成患者入组并计划启动联合治疗非小细胞肺癌的Ⅲ期临 床研究,看好后续临床潜力。 荣昌生物(09995)涨超3%,截至发稿,涨3.41%,报78.8港元,成交额9838.12万港元。 消息面上,华西证券(002926)研报指出,根据荣昌生物官方公众号,公司自主研发PD-1/VEGF双特异 性抗体RC148单药一线及联合方案二线治疗非小细胞肺癌Ⅰ/Ⅱ期临床研究数据公布。研究数据显示, RC148单药与联合方案均显示出突出的临床疗效和可控的安全性,实现了双路径突破。 ...
港股异动 | 荣昌生物(09995)涨超3% 自研RC148实现双路径突破 机构看好后续临床潜力
智通财经网· 2025-12-23 02:08
该行表示,基于RC148-C001研究的早期数据,2025年8月,RC148联合多西他赛治疗经PD-1/PD-L1 抑 制剂和含铂化疗(联合或序贯)治疗失败的驱动基因阴性局部晚期或转移性非小细胞肺癌适应症已获得中 国突破性治疗药物资格认定(BTD)。目前公司正在积极推进相关临床:根据公司投资者调研纪要, RC148联合治疗一线非小细胞肺癌的II期临床试验已完成患者入组并计划启动联合治疗非小细胞肺癌的 Ⅲ期临床研究,看好后续临床潜力。 消息面上,华西证券研报指出,根据荣昌生物官方公众号,公司自主研发PD-1/VEGF双特异性抗体 RC148单药一线及联合方案二线治疗非小细胞肺癌Ⅰ/Ⅱ期临床研究数据公布。研究数据显示,RC148单 药与联合方案均显示出突出的临床疗效和可控的安全性,实现了双路径突破。 智通财经APP获悉,荣昌生物(09995)涨超3%,截至发稿,涨3.41%,报78.8港元,成交额9838.12万港 元。 ...
荣昌生物(09995):核心产品医保谈判顺利,RC148非小细胞肺癌数据披露积极荣昌生物
HUAXI Securities· 2025-12-19 11:55
Investment Rating - The investment rating for the company is "Buy" [4] Core Insights - The company's core products have successfully been included in the 2025 National Medical Insurance Drug List, which is expected to drive sales growth [1][3] - The clinical data for the PD-1/VEGF bispecific antibody RC148 shows promising efficacy and safety in treating non-small cell lung cancer, indicating a significant clinical advantage [2][4] - The management team is experienced, and the company has a strong R&D capability, with a stable pipeline of clinical indications [8] Summary by Sections Event 1 - Two innovative drugs from the company have been successfully included in the 2025 National Medical Insurance Drug List, with one new indication for 泰爱® (Tai'ai) and three renewed indications for both 泰爱® and 爱地希® (Aidiqi) [1] Event 2 - The clinical research data for RC148 in treating non-small cell lung cancer has been disclosed, showing outstanding clinical efficacy and manageable safety [2] Clinical Data - The clinical trial results for RC148 indicate an objective response rate (ORR) of 61.9% for monotherapy and 66.7% for combination therapy, with a disease control rate (DCR) of 100% and 95.2% respectively [4] Financial Projections - Revenue projections for 2025-2027 are adjusted to 27.52 billion, 33.85 billion, and 44.13 billion yuan, reflecting year-on-year growth rates of 60.95%, 22.97%, and 30.40% respectively [8] - The net profit for the same period is projected to improve significantly, with estimates of -7.63 billion, -3.16 billion, and 3.84 billion yuan [8]
港股异动 | 荣昌生物(09995)盘中涨超7% 公布PD-1/VEGF双抗非小细胞肺癌临床数据
智通财经网· 2025-12-11 02:52
Core Viewpoint - Rongchang Biopharmaceutical (09995) experienced a significant stock increase, with a rise of over 7% during trading, closing at 81.5 HKD, with a transaction volume of 310 million HKD, following the presentation of clinical trial data for its PD-1/VEGF bispecific antibody RC148 at the ESMO-IO conference in London [1]. Group 1: Clinical Trial Data - The clinical trial data for RC148, a PD-1/VEGF bispecific antibody, was presented at the ESMO-IO conference, showcasing its efficacy in treating non-small cell lung cancer [1]. - The trial results indicated an overall response rate (ORR) of 66.7% and a disease control rate (DCR) of 95.2% for the 20 mg/kg Q3W dosage combined with docetaxel [1]. - Among patients with PD-L1 positive status (TPS≥1%), the ORR reached 80%, with a median follow-up time of approximately 7 months and a median progression-free survival (mPFS) of 8.3 months [1]. Group 2: Regulatory Approvals and Market Potential - RC148 received FDA approval in August to initiate a Phase II clinical trial in the United States, marking a significant step in its global clinical development [1]. - The drug has also been approved in China for clinical research in monotherapy and combination therapy for advanced solid tumors, indicating strong confidence in its clinical progress [1]. - The global business development (BD) activity for PD-1/VEGF therapies is heating up, with companies like Kangfang Biopharmaceutical and 3SBio already pursuing international licensing agreements, positioning RC148 favorably in the competitive landscape [1].
研报掘金丨中泰证券:维持荣昌生物“增持”评级,大幅扭亏盈利拐点将至
Ge Long Hui A P P· 2025-12-03 08:00
格隆汇12月3日|中泰证券研报指出,荣昌生物前三季度营收增长强劲, 亏损大幅收窄的积极态势。大 幅扭亏盈利拐点将至,引领重症肌无力疗法变革浪潮。泰它西普新适应症取得积极进展,迎接gMG治 疗领域创新药物的爆发风口。根据clinical trials,泰它西普治疗重症肌无力的海外III期研究预计在2026 年完成,迎来国际化元年,若能够在海外成功上市将有望为公司带来可观的增量市场。公司布局了包括 RC148(PD-1/VEGF 双抗)在内的多个在研项目,并探索内部药物(如RC148 与Claudin18.2 ADC RC118)联用的潜力,为长期发展储备了动能。荣昌生物正处在商业化能力加速兑现的通道上,通过高 效的运营和精准的投入,公司正快速向盈亏平衡点靠拢。维持"增持"评级。 ...
港股异动 荣昌生物(09995)午后涨超7% 泰它西普快速放量 维迪西妥联合免疫疗效优异
Jin Rong Jie· 2025-11-27 06:06
Core Viewpoint - Rongchang Biologics (09995) experienced a significant stock increase, rising over 7% in the afternoon trading session, with a current price of 90.75 HKD and a trading volume of 319 million HKD, indicating strong market interest and potential investor confidence [1]. Group 1: Clinical Research and Product Development - At the 2025 ESMO annual meeting, clinical research results were published showing that Vidisicimab combined with Toripalimab outperformed chemotherapy as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma [1]. - Yongxing Securities reported that the combination therapy of Vidisicimab demonstrates excellent efficacy, marking a significant change in the treatment landscape for urothelial carcinoma [1]. - CITIC Construction Investment noted that in 2025, the core product Taitasip will rapidly expand after receiving approval for new indications, and the data for the combination treatment with Vidisicimab is promising [1]. Group 2: Pipeline and Market Position - The application for the DME indication of RC28 has been accepted, indicating progress in the company's pipeline [1]. - Among the pipeline products, RC148 has received breakthrough therapy designation, with continuous validation of its clinical data [1]. - Overall, the company is accelerating its commercialization process and has a well-structured pipeline, suggesting a positive outlook for future development [1].
港股异动 | 荣昌生物(09995)午后涨超7% 泰它西普快速放量 维迪西妥联合免疫疗效优异
智通财经网· 2025-11-27 05:51
Core Viewpoint - Rongchang Biopharmaceutical (09995) experienced a significant stock increase, rising over 7% in the afternoon trading session, with a current price of 90.75 HKD and a trading volume of 319 million HKD, indicating strong market interest and confidence in the company's future prospects [1] Group 1: Clinical Research and Product Development - The 2025 ESMO annual meeting presented clinical research results showing that Vidisicimab combined with Toripalimab outperforms chemotherapy as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma [1] - Yongxing Securities reported that the combination therapy of Vidisicimab demonstrates excellent immunotherapy efficacy, marking a significant change in the treatment landscape for urothelial carcinoma [1] - CITIC Securities highlighted that in 2025, the core product Taitasip will rapidly expand after receiving approval for new indications, and the data for the combination treatment of Vidisicimab is outstanding [1] Group 2: Pipeline and Market Position - The application for the DME indication of RC28 has been accepted, indicating progress in the company's pipeline [1] - The investigational drug RC148 has received breakthrough therapy designation, with continuous validation of its clinical data, suggesting strong potential for future market success [1] - Overall, the company is accelerating its commercialization process and has a well-structured pipeline, which bodes well for its future development [1]
荣昌生物午后涨超7% 泰它西普快速放量 维迪西妥联合免疫疗效优异
Zhi Tong Cai Jing· 2025-11-27 05:49
Core Viewpoint - Rongchang Biologics (09995) experienced a significant stock increase, rising over 7% in the afternoon trading session, with a current price of 90.75 HKD and a trading volume of 319 million HKD, driven by positive clinical research news regarding its product candidates [1] Group 1: Clinical Research Developments - At the 2025 ESMO annual meeting, the clinical study results for Vidisicimab combined with Toripalimab versus chemotherapy for first-line treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma were released, indicating a major shift in the treatment landscape for urothelial carcinoma [1] - Yongxing Securities reported that the combination therapy of Vidisicimab shows excellent immunotherapy efficacy, marking a significant change in the treatment paradigm for urothelial carcinoma [1] Group 2: Product Pipeline and Market Potential - CITIC Construction Investment (601066) highlighted that in 2025, the core product Taitasip will rapidly expand after receiving approval for new indications, and the data for the combination treatment of Vidisicimab is promising [1] - The application for the market approval of RC28 for DME indication has been accepted, and the investigational pipeline includes RC148, which has received breakthrough therapy designation, with continuous validation of its clinical data [1] - Overall, the company is accelerating its commercialization process and has a well-structured pipeline, indicating a positive outlook for future development [1]
肿瘤治疗2.0时代,创新药竞逐新高地
Core Insights - The approval of PD-1 inhibitors Keytruda and Opdivo a decade ago has significantly transformed cancer treatment, particularly in lung cancer, melanoma, and lymphoma, marking the beginning of the immunotherapy era [1] - As key patents near expiration and biosimilars enter the market, the market share of leading products is under pressure, with Merck's Keytruda sales growth slowing to 8% and BMS's Opdivo experiencing a 1% decline [1] - The oncology market is evolving into a "2.0 era," with companies like Merck and BMS focusing on combination therapies involving PD-1 and ADCs to maintain competitive advantages [1][2] Industry Overview - The global oncology drug market is projected to grow from $168 billion in 2020 to $247 billion by 2024, with a compound annual growth rate (CAGR) of 10.2%, while the ADC market is expected to exceed $35 billion with a CAGR of 41.7% [1] - The shift in market dynamics indicates a move towards a multi-target competition era, emphasizing ADCs and combination therapies [1] Company Strategies - Merck is actively building a "PD-1+ADC" treatment matrix through acquisitions and partnerships, aiming to extend the lifecycle of Keytruda [2] - Recent FDA approvals for combination therapies, such as Keytruda with Padcev for bladder cancer, highlight the potential for these combinations to change clinical practices [3] - BMS has also expanded its combination therapies, with its dual immunotherapy for liver cancer becoming the first approved in China [3] Domestic Innovations - Chinese biotech companies are rapidly advancing in the "PD-1+ADC" space, with companies like Junshi Biosciences reporting promising clinical data for their PD-L1 ADC, HLX43, in non-small cell lung cancer [4] - The industry is moving towards "dual antibodies/multi-antibodies + ADC" strategies, with companies like Rongchang Bio and Pfizer exploring innovative combinations [5] Future Directions - The next generation of IO and ADC therapies is expected to become a focal point for multinational corporations in the oncology sector, with a strong emphasis on business development in China [6] - Companies are increasingly inclined to pursue co-development models as clinical data becomes more robust, indicating a trend towards strategic partnerships in the industry [6]
海外社服:百胜中国3Q25加快开店步伐,同店收入维持正增长,利润率提升:海外消费周报(20251031-20251106)-20251107
Investment Rating - The industry investment rating is "Overweight" [6] Core Insights - Yum China reported Q3 2025 revenue of $3.2 billion, a year-on-year increase of 4%, and core operating profit of $399 million, up 8%, aligning with expectations [1][4] - The net new store openings for KFC and Pizza Hut reached a record high in Q3, with a total of 536 new stores, bringing the total to 17,514 [2][4] - Same-store sales for KFC increased by 2% year-on-year, while Pizza Hut saw a 1% increase, marking the 12th consecutive quarter of positive same-store sales growth [5] Summary by Sections Overseas Catering - Yum China achieved Q3 2025 revenue of $3.2 billion, a 4% increase year-on-year, and core operating profit of $399 million, an 8% increase, meeting expectations [1][4] - KFC and Pizza Hut net new store openings reached a record high in Q3, with 536 new stores added, totaling 17,514 stores [2][4] - KFC's same-store sales increased by 2% year-on-year, with transaction volume up 3% and average ticket price down 1% to 38 yuan [5] Overseas Pharmaceuticals - Rongchang Biologics reported a 42.3% year-on-year revenue increase in the first three quarters of 2025, reaching 1.72 billion yuan, with a net loss of 551 million yuan, narrowing by 48.6% [8] - In Q3, revenue grew by 33.1% year-on-year and 8.7% quarter-on-quarter, reaching 622 million yuan, with a net loss of 101 million yuan, narrowing by 65.2% year-on-year [8] - The company’s R&D expenses decreased by 22.8% year-on-year to 891 million yuan in the first three quarters [8] Overseas Education - The education sector's growth rate has bottomed out, with New Oriental's revenue growth accelerating due to its strong reputation [3] - The education index fell by 6.0% in the week of October 31 to November 6, underperforming the Hang Seng Index by 6.1 percentage points [15] - New Oriental's GMV on Douyin was approximately 170 million yuan for the week, with a daily average of 24.2 million yuan, reflecting a 2.7% week-on-week decline [16]