公司营收快速增长，经营效能持续提升：1H25 收入10.98 亿元（+48.0%yoy），1H25 归母净亏损/扣非 归母净亏损4.50/4.46 亿元，同比减亏42.4/43.9%，其中2Q25 公司经营性现金流流出环比显著缩窄69%。 我们看好公司的长期发展潜力：1）国内，核心产品销售稳步增长，我们预计全年收入有望30%+增长， RC28 达成授权即将步入商业化；2）泰它西普BD出海落地，看好MG 等适应症全球竞争力，维迪西妥 单抗海外III 期正加速入组，此外RC148 已在IO 耐药患者中取得积极疗效信号，多家MNC 对PD- 1/VEGF 双抗有BD 需求，我们看好其出海潜力。维持A 股和H 股"买入"评级。 盈利预测与估值 国内销售快步增长，新适应症兑现在即 考虑到公司产品国内适应症有序拓展，商业化效率提升，研发更为聚焦，我们预计公司25 年亏损将逐 渐收窄，26 年接近盈亏平衡，并于27 年实现盈利，我们预期公司25-27 年归母净利润(3.46)/0.03/5.36 亿 元。基于DCF 的A 股/H 股目标价为107.37 元/116.94 港币（WACC：6.8%，永续增长率2.5%）。 核 ...

智通财经APP获悉，荣昌生物(09995)再涨超4%，截至发稿，涨4.17%，报92.4港元，成交额6.25亿港 元。 华泰证券指出，看好公司的长期发展潜力：国内，核心产品销售稳步增长，该行预计全年收入有望 30%+增长，RC28达成授权即将步入商业化；泰它西普BD出海落地，看好MG等适应症全球竞争力，维 迪西妥单抗海外III期正加速入组，此外RC148已在IO耐药患者中取得积极疗效信号，多家MNC对PD- 1/VEGF双抗有BD需求，该行看好其出海潜力。 消息面上，荣昌生物近日公布2025年中期业绩，产品销售及研发服务收益为10.92亿元，同比增长 47.6%；研发开支同比减少19.7%至6.47亿元，净亏损约4.5亿元，同比减少42.4%。公告称，收益增加乃 主要由公司自身免疫类商业化产品泰它西普及抗肿瘤类商业化产品维迪西妥单抗的销售放量导致销售收 入同比增长强劲。 ...

Summary of Rongchang Biopharmaceuticals Conference Call Company Overview - **Company**: Rongchang Biopharmaceuticals - **Industry**: Biopharmaceuticals Key Financial Performance - **Revenue**: Approximately 4.4 billion CNY in H1 2025, a year-on-year increase of 38% [2][3] - **Net Loss**: 450 million CNY, a reduction of 42.4% year-on-year [2][3] - **Cash Reserves**: Approximately 1.48 billion CNY in cash and notes, with an additional 2.7 billion CNY in bank credit lines [2][3] Product Sales and Market Strategy - **Tadasucept**: Revenue of approximately 650 million CNY in H1 2025, a 59% increase year-on-year; entered over 1,000 hospitals with nearly 600 officially approved [2][6] - **Vitesi Monoclonal Antibody**: Sales of approximately 4.4 billion CNY in H1 2025, a 38% increase; entered about 1,000 hospitals with around 450 officially approved [2][11] - **RC48**: Positive results in Phase III trials for urothelial carcinoma; BLA submission in progress [2][5] Research and Development Progress - **RC148**: Received FDA breakthrough therapy designation for non-small cell lung cancer; ongoing clinical trials and international collaborations [4][8][25] - **New Drug Developments**: RC278 and RC288 are in patient enrollment stages; RC28 for ophthalmic diseases is expected to submit DME application this year [9][21] - **Clinical Trials**: Tadasucept's MG clinical trial data to be updated at the AANEM conference in October [23][25] Financial and Operational Outlook - **Sales Growth Target**: 30% revenue growth for the full year 2025, with H1 growth at 48% [4][30] - **Cost Management**: Continued reduction in sales expense ratio, expected to maintain or further decrease in H2 2025 [17][18] - **Funding Strategy**: Plans to increase early-stage R&D investment, focusing on ADCs, bispecific antibodies, and fusion proteins [21][22] Competitive Landscape and Market Position - **Market Strategy**: Focus on expanding coverage in lower-tier cities and enhancing physician engagement in rheumatology and nephrology [6][10] - **Product Differentiation**: Tadasucept's mechanism offers advantages over competitors, particularly in long-term use and safety [23][41] Future Catalysts and Milestones - **Upcoming Data Releases**: Important data updates expected in H2 2025, including MG and dry syndrome trial results [38] - **Regulatory Submissions**: Anticipated BLA submissions for multiple products, with a focus on maintaining competitive advantages in the market [20][30] Conclusion Rongchang Biopharmaceuticals is positioned for significant growth with a strong pipeline of products and a focus on strategic market expansion. The company aims to optimize its financial structure while enhancing its R&D capabilities to drive future success.

医药生物 2025 年 08 月 24 日 投资评级：看好（维持） 行业走势图 数据来源：聚源 -12% 0% 12% 24% 36% 48% 2024-08 2024-12 2025-04 医药生物 沪深300 相关研究报告 《国谈药品初审名单公布，关注相关 公司的投资机会 — 行 业 周 报 》 -2025.8.17 《二代 IO 升级迭代，PD-1/VEGF 三抗 加速推进—行业周报》-2025.8.10 《设备更新政策持续深化，医疗设备 招采稳步复苏—行业周报》-2025.8.3 关注 PD-(L)1/VEGF 双抗海内外临床进展 ——行业周报 | 余汝意（分析师） | 余克清（分析师） | 聂媛媛（联系人） | | --- | --- | --- | | yuruyi@kysec.cn | yukeqing@kysec.cn | nieyuanyuan@kysc.cn | | 证书编号：S0790523070002 | 证书编号：S0790525010002 | 证书编号：S0790124050002 | PD-(L)1/VEGF 双抗赛道第一梯队海外临床加速开展 依沃西单抗（康方生物/Summit ...

Investment Rating - The report maintains an "Optimistic" rating for the industry [7][71]. Core Insights - The report highlights the intensive disclosure of company performances, with a focus on companies that exceed expectations. It emphasizes the upcoming World Lung Cancer Conference (WCLC) and the importance of monitoring related company data [6][70]. - The report notes a significant increase in the medical device sector and mentions the approval of new treatments by regulatory bodies, indicating a positive trend in the pharmaceutical and medical device industries [2][16]. Industry News - The National Healthcare Security Administration issued a temporary management method for disease-based payment, which includes budget management and payment standards [16]. - Semaglutide received FDA approval for treating MASH, showcasing advancements in drug approvals [16]. Company Announcements - **Hengrui Medicine** reported a revenue of approximately 15.76 billion yuan for the first half of 2025, a year-on-year increase of 15.88%, and a net profit of approximately 4.45 billion yuan, up 29.67% [25]. - **Baili Tianheng** announced a significant drop in revenue but received breakthrough therapy designation from the FDA for its drug targeting advanced non-small cell lung cancer [28]. - **Rongchang Bio** received breakthrough therapy designation for its drug RC148 for non-small cell lung cancer and signed a licensing agreement [29]. - **Baiyao Tai** reported a revenue of approximately 441.89 million yuan, a year-on-year increase of 9.84%, and received EMA approval for Usymro® [30]. Market Review - The Shanghai Composite Index rose by 2.85%, while the pharmaceutical and biological sector increased by 1.85% during the week of August 15-21, 2025 [5][59]. - The industry’s price-to-earnings ratio (TTM) was reported at 31.23 times, with a valuation premium of 154% compared to the CSI 300 index [5][63]. Weekly Strategy - The report suggests focusing on companies with performance exceeding expectations during the earnings disclosure period and highlights the potential benefits from policy support for innovative drugs and medical devices [6][70].

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 ...

荣昌生物公告，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局药品审评中心(CDE)正 式纳入突破性治疗药物品种，针对适应症为：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(NSCLC)。 ...

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 ...