Investment Rating - The report maintains an "Outperform" rating for Sino Biopharmaceutical with a target price of HKD 10.87, reflecting a positive outlook on the company's performance [2][7]. Core Insights - Sino Biopharmaceutical achieved revenue of CNY 17.6 billion in 1H25, representing an 11% year-on-year increase, with a gross profit margin of 82.5% [3][12]. - The company's innovative drug sales reached CNY 7.8 billion, growing by 27% year-on-year, while generic drug revenue was CNY 9.8 billion, showing slight growth [4][13]. - The report highlights the strong growth drivers in oncology and surgery/analgesia segments, with oncology revenue at CNY 6.7 billion (+25% YoY) and surgery/analgesia revenue at CNY 3.1 billion (+20% YoY) [19]. Financial Performance - Revenue forecasts for 2025 and 2026 have been raised to CNY 33.4 billion and CNY 37.6 billion, respectively, due to expected growth in out-licensing revenue [17]. - Net profit attributable to parent shareholders is adjusted to CNY 4.8 billion and CNY 5.1 billion for FY25E and FY26E, respectively [17]. - The report indicates a projected diluted EPS of CNY 0.27 for 2025 and CNY 0.28 for 2026, with a gross profit margin expected to remain stable at 82.5% [10][17]. Clinical Pipeline and Growth Potential - The respiratory portfolio includes multiple candidates in clinical stages, with significant progress in PDE3/4 inhibitors for COPD and TSLP monoclonal antibodies for asthma [4][14]. - Six innovative products are expected to launch in 2025, including key products like TQB3616 (CDK2/4/6 inhibitor) and HER2 inhibitors [15][16]. - The report emphasizes the potential for out-licensing several innovative products in oncology and respiratory pipelines, which could enhance revenue streams [16].

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 中國生物製藥有限公司 呈交日期: 2025年9月1日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01177 | 說明 | - | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 30,000,000,000 | HKD | | 0.025 | HKD | | 750,000,000 | | 增加 / 減少 (-) | | | 0 | | | | HKD | | 0 | | 本月底結存 | | | 30,000,000,000 | HKD | | 0.025 | HKD | | 750,000,000 ...

Group 1 - The core point of the article is the approval of the oral HER2 tyrosine kinase inhibitor, Saint Heru (Zong Aitini), for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 activation mutations in mainland China [1] - Saint Heru is the first and currently the only approved oral HER2 tyrosine kinase inhibitor in the industry, addressing a significant unmet medical need in lung cancer treatment [1] - The approval reflects the high recognition of the clinical value of this innovative drug by the National Medical Products Administration, as it received "breakthrough therapy designation" and "priority review" status, leading to accelerated approval [1] Group 2 - The strategic partnership between Boehringer Ingelheim and China National Pharmaceutical Group aims to bring innovative oncology therapies to the mainland Chinese market [2] - The collaboration will focus on multiple innovative oncology products from Boehringer Ingelheim that are in late-stage clinical development, enhancing the treatment options available for cancer patients in China [2]

相关事件 中国生物制药(01177.HK)宗艾替尼片获批上市 中国生物制药(01177.HK)："TQC3721(PDE3/4抑制 剂)"、"TQC2731(TSLP单抗)"、"TQC3403(乌美溴铵维兰特罗吸入粉雾剂)"共4项研究数据在ERS2025公 布 格隆汇8月29日丨中国生物制药(01177.HK)公告，集团与勃林格殷格翰在中国大陆联合推广的宗艾替尼 片(商品名：圣赫途®)已获得中国国家药品监督管理局的上市批准，用于治疗存在HER2(ERBB2)激活突 变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者。 圣赫途®是全球首个且目前唯一获批的口服HER2酪氨酸激酶抑制剂，此次在华获得附条件批准是基于 Beamion-LUNG1研究的积极结果，该试验评估了宗艾替尼在HER2(ERBB2)突变晚期NSCLC患者中的疗 效和安全性。 数据显示，在接受治疗的队列1经治患者(N=75)中，客观缓解率(ORR)达71%(95%CI：60-80)，其中7% 为完全缓解，疾病控制率(DCR)高达96%。中位缓解持续时间(DoR)达14.1个月，中位无进展生存期 (PFS)达 ...

数据显示，在接受治疗的队列1经治患者(N=75)中，客观缓解率(ORR)达71%(95%CI：60-80)，其中7% 为完全缓解，疾病控制率(DCR)高达96%。中位缓解持续时间(DoR)达14.1个月，中位无进展生存期 (PFS)达12.4个月。该数据已在2025年美国癌症研究协会(AACR)年会上公布，并同步刊发于《新英格兰 医学杂志》。此外，宗艾替尼的安全性可控，研究中治疗中断率仅2.9%。 肺癌无论在全球还是中国，均为第一大癌种，临床仍存在巨大的未满足治疗需求。圣赫途在中国获批， 将为国内众多HER2突变非小细胞肺癌患者带来更高效、依从性更佳的治疗选择，也将进一步丰富集团 在肿瘤领域的产品线，争取为更多患者带来治疗获益，用『健康科技，温暖更多生命』。 中国生物制药(01177)发布公告，集团与勃林格殷格翰在中国大陆联合推广的宗艾替尼片(商品名：圣赫 途)已获得中国国家药品监督管理局的上市批准，用于治疗存在HER2(ERBB2)激活突变且既往接受过至 少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者。 圣赫途是全球首个且目前唯一获批的口服HER2酪氨酸激酶抑制剂，此次在华获得 ...

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，並明確表示，概不對因本公告全部或任何部份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。 （於開曼群島註冊成立之有限公司） 網站：www.sinobiopharm.com （股份編號：1177） 自願公告 宗艾替尼片獲批上市 中國生物製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」）宣佈，本集團與 勃林格殷格翰在中國大陸聯合推廣的宗艾替尼片（商品名：聖赫途® ）已獲得中國國家藥品監督管理局 的上市批准，用於治療存在HER2（ERBB2）激活突變且既往接受過至少一種系統治療的不可切除的局 部晚期或轉移性非小細胞肺癌（NSCLC）成人患者。 1 肺癌無論在全球還是中國，均為第一大癌種，臨床仍存在巨大的未滿足治療需求。聖赫途®在中國獲 批，將為國內眾多HER2突變非小細胞肺癌患者帶來更高效、依從性更佳的治療選擇，也將進一步豐 富本集團在腫瘤領域的產品線，爭取為更多患者帶來治療獲益，用『健康科技，溫暖更多生命』。 [1] Heymach, J. et al. Zongert ...

8月29日，勃林格殷格翰与中国生物制药(01177.HK)共同宣布，双方在中国大陆联合推广的圣赫途(中文 通用名：宗艾替尼片，英文通用名：zongertinib)获得中国国家药品监督管理局正式批准，用于治疗存在 HER2(ERBB2)激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌 (NSCLC)成人患者。 圣赫途是全球首个且目前唯一获批的口服HER2酪氨酸激酶抑制剂，此次在华获得附条件批准是基于 Beamion-LUNG1研究的积极结果，该试验评估了宗艾替尼在HER2(ERBB2)突变晚期非小细胞肺癌 (NSCLC)患者中的疗效和安全性。数据显示，在接受治疗的队列1经治患者(N=75)中，客观缓解率 (ORR)达71%(95%CI：60-80)，其中7%为完全缓解，疾病控制率(DCR)高达96%。中位缓解持续时间 (DoR)达14.1个月，中位无进展生存期(PFS)达12.4个月。该数据已在2025年美国癌症研究协会(AACR)年 会上公布，并同步刊发于《新英格兰医学杂志》。此外，宗艾替尼的安全性可控，研究中治疗中断率仅 2.9%。 中国胸部肿瘤研究协作组(CTONG)主席、广东 ...

Core Insights - China National Pharmaceutical Group's subsidiary, Chengdu Tianqing Pharmaceutical, has successfully completed the first shipment of innovative anti-cancer drugs to the Hong Kong-based Greater China Cancer Foundation, marking a significant step in their collaboration [1][2] - The shipment includes innovative anti-cancer drugs Anlotinib and Bemarituzumab, providing new treatment options for cancer patients in Hong Kong with urgent medical needs [1][2] - The Named Patient Program (NPP) allows doctors to provide unregistered drugs to patients in need, aligning with the Hong Kong government's 2023 policy report aimed at improving drug accessibility [1][2] Company Collaboration - The partnership agreement between Chengdu Tianqing and the Greater China Cancer Foundation was signed in March, focusing on providing innovative cancer treatment solutions to patients with significant unmet medical needs in Hong Kong [2] - The efficient completion of compliance reviews and cross-border logistics demonstrates the effectiveness of the NPP model in enhancing drug accessibility [2] - The president of Chengdu Tianqing emphasized the commitment to advancing China's pharmaceutical development and ensuring that innovative products reach Hong Kong patients [2] Social Responsibility - China National Pharmaceutical Group integrates corporate social responsibility into its development strategy, actively participating in charitable initiatives [3] - The successful shipment enhances treatment options for cancer patients in Hong Kong and reflects the deepening and innovative collaboration between mainland China and Hong Kong in the healthcare sector [3]

Core Viewpoint - The company reported strong financial performance in the first half of 2025, with significant growth in both revenue and net profit, driven by innovative products and a solid position in key therapeutic areas [1][2]. Financial Performance - In H1 2025, the company achieved revenue of 17.57 billion (CNY) (+10.7%) and a net profit attributable to shareholders of 3.39 billion (CNY) (+140.2%) [1]. - Adjusted net profit (non-HKFRS) reached 3.09 billion (CNY) (+101.1%), indicating a substantial increase in profitability [1]. Innovation and Product Development - The company launched two innovative products approved by NMPA in H1 2025, contributing to a revenue of 7.8 billion (CNY) from innovative products (+27.2%), which now account for 44.4% of total revenue (+5.8 percentage points) [1]. - The company has a broad pipeline of nearly 20 innovative products expected to be approved between 2025 and 2027, with over half projected to have peak sales exceeding 2 billion (CNY) [2]. Business Segments - The oncology segment generated revenue of 6.694 billion (CNY) (+24.9%), while the surgical/pain management segment achieved revenue of 3.105 billion (CNY) (+20.2%) in H1 2025 [1]. Future Outlook - The company anticipates that the proportion of revenue from innovative products will increase to 50% in 2025, 55% in 2026, and 60% in 2027, positioning innovation as the core driver of revenue growth [2]. - The acquisition of Lixin Pharmaceutical is expected to enhance the company's innovation pipeline and strengthen its core technology capabilities [2]. Profit Forecast - Revenue projections for 2025-2027 are 32.78 billion (CNY), 36.87 billion (CNY), and 41.14 billion (CNY), with year-on-year growth rates of 13.6%, 12.5%, and 11.6% respectively [3]. - Net profit forecasts for the same period are 4.81 billion (CNY), 4.88 billion (CNY), and 5.12 billion (CNY), with growth rates of 37.5%, 1.5%, and 4.8% respectively [3].

事件描述 机构：长江证券 研究员：彭英骐/刘长洪 礼新医药差异化补足技术平台，助力全球FIC/BIC 管线。公司宣布7 月15 日以5 亿美元净对价全资收购 礼新医药科技（上海）有限公司（礼新医药）。礼新医药拥有全球领先的抗体发现与ADC 技术平台， 包括肿瘤微环境特异性抗体开发平台（LM-TMETM）、针对难成药靶点的抗体开发平台（LM- AbsTM）、新一代ADC 药物平台（LM-ADCTM）、以及免疫细胞衔接器平台（LM-TCETM）。公司 将加速推进礼新医药创新管线的转化，包括LM-299（PD-1/VEGF 双抗）、LM-305（GPRC5D ADC）、LM-108（CCR8 单抗）、LM-302（Claudin18.2 ADC）、LM-168（CTLA-4TME 单抗）和LM- 364（Nectin-4 TME ADC）。 盈利预测：预计公司2025-2027 年归母净利润分别为34.54 亿元、39.79 亿元及45.70 亿元，对应EPS 分 别为0.18 元、0.21 元及0.24 元，维持"买入"评级。 风险提示 1、销售不及预期风险； 事件评论 财务增长强劲，创新持续扩容。2025H1 ...