（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 LM-24C5「CEACAM5/4-1BB 雙抗」II期臨床試驗申請獲NMPA批准 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， 本集團全資附屬公司禮新醫藥科技（上海）有限公司（「禮新醫藥」）自主研發的創新藥LM-24C5 「CEACAM5/4-1BB雙抗」已獲得中國國家藥品監督管理局(NMPA)的臨床試驗批准，同意其在 CEACAM5陽性的晚期實體瘤患者中開展一項聯合其他抗腫瘤藥物的II期臨床試驗。 CEACAM5（癌胚抗原相關細胞黏附分子5）在多種實體瘤中高表達，包括非小細胞肺癌、結直腸癌和 胃癌等，使其成為一個極具前景的腫瘤治療靶點[1]。LM-24C5是禮新醫藥基於條件激活型4-1BB平台 開發的雙特異性抗體，通過特異性結合腫瘤細胞表面的CEACAM5和免疫細胞表面的4-1BB，將免疫 細胞特異性定向至腫瘤微環境，激活並增強其抗腫瘤活性。LM-24C5的獨特結構可以CEACAM5依 賴性方式選擇性激活4-1BB信號通路，避免非特異性外周免疫系 ...

Core Viewpoint - China National Pharmaceutical Group's self-developed drug TQ05105 (Ruxolitinib) has been included in the Breakthrough Therapy Designation (BTD) program by the CDE for the treatment of chronic graft-versus-host disease (cGVHD) [1][2] Group 1: Drug Development and Approval - Ruxolitinib is the fastest progressing JAK/ROCK dual small molecule inhibitor globally [1] - The company submitted a marketing application for Ruxolitinib to the CDE in July 2024, which has been accepted for the treatment of intermediate to high-risk myelofibrosis (MF) [1] - Currently, Ruxolitinib is undergoing a Phase III clinical trial for cGVHD in China and has been approved for a Phase II clinical trial in the United States [1] Group 2: Clinical Trial Results - The Phase Ib/IIa clinical results for Ruxolitinib were published in the top journal "Blood," involving 44 patients with moderate to severe steroid-refractory or dependent cGVHD [2] - No dose-limiting toxicities were observed, and there were no adverse events leading to discontinuation related to Ruxolitinib [2] - The best overall response rate (BOR) was 86.4%, with a 12-month failure-free survival rate (FFS) of 85.2% [2] - 88.6% of participants reduced their steroid dosage requirements, and 59.1% experienced improvement in cGVHD-related symptoms [2] - The company is accelerating the global clinical development of Ruxolitinib to provide better treatment options for patients worldwide [2]

Core Insights - China National Pharmaceutical Group's self-developed drug TQ05105 (Ruxolitinib) has been included in the Breakthrough Therapy Designation (BTD) program by the CDE for the treatment of chronic graft-versus-host disease (cGVHD) [1][2] - Ruxolitinib is the fastest progressing JAK/ROCK dual small molecule inhibitor globally, with a marketing application submitted to CDE for myelofibrosis (MF) treatment [1] - The drug is currently undergoing Phase III clinical trials for cGVHD in China and has received approval for Phase II trials in the United States [1] Clinical Trial Results - Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective treatment for malignant hematological diseases, with cGVHD being a major complication occurring in 30%-70% of cases [2] - Phase Ib/IIa clinical trial results published in the journal "Blood" included 44 patients with moderate to severe steroid-refractory or dependent cGVHD, showing no dose-limiting toxicities and no drug-related adverse events leading to discontinuation [2] - The best overall response rate (BOR) was 86.4%, with a 12-month failure-free survival rate (FFS) of 85.2%, and 88.6% of participants reduced their steroid dosage requirements, while 59.1% experienced improvement in cGVHD-related symptoms [2] - The company is accelerating the global clinical development of Ruxolitinib to provide better treatment options for patients worldwide [2]

Core Viewpoint - China Biologic Products (01177.HK) announced that its self-developed drug TQ05105 (a JAK/ROCK inhibitor) has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China for the treatment of chronic graft-versus-host disease (cGVHD) [1] Group 1 - TQ05105 is the fastest developing dual small molecule inhibitor of JAK/ROCK globally [1] - The company submitted a marketing application for TQ05105 to the CDE in July 2024, which has been accepted for the treatment of intermediate to high-risk myelofibrosis (MF) [1] - Currently, TQ05105 is undergoing a Phase III clinical trial for cGVHD in China, and has been approved to conduct a Phase II clinical trial in the United States [1] Group 2 - The Phase III clinical trial for TQ05105 in treating moderate to severe cGVHD is currently in the subject recruitment phase [1] - The company aims to accelerate the global clinical development of TQ05105 to provide better treatment options for patients worldwide as soon as possible [1]

（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 羅伐昔替尼片「JAK/ROCK抑制劑」 納入突破性治療藥物程序 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，本集團自 主研發的羅伐昔替尼片「TQ05105 （JAK/ROCK抑制劑）」已被中國國家藥品監督管理局藥品審評中心 (CDE)納入突破性治療藥物程序(BTD)，用於慢性移植物抗宿主病(cGVHD)的治療。 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。 異基因造血干細胞移植(allo-HSCT)是治療惡性血液系統疾病的一種有效方式，而慢性移植物抗宿主 病(cGVHD)是allo-HSCT的主要併發症之一，發生率可達30%-70%[1]。羅伐昔替尼的Ib/IIa期臨床結果 已發表於國際血液學領域頂級期刊《Blood》：該研究共納入44例中度或重度糖皮質激素難治性或依賴 性cGVHD患者， ...

软雾吸入剂是新一代吸入剂型，利用机械动力以缓慢的细雾形式向患者递送药物。相较于传统的雾化、 干粉等剂型，软雾吸入剂能使气溶胶释放时间更长、速度更慢，并减少药物在口咽部的损失，使得药物 的肺部沉积率更高，同时对患者的手口协调性要求较低，对于儿童、老人等给药困难人群同样适用。 目前，全球尚无ICS/LAMA/LABA三联复方软雾吸入制剂获批上市。本集团正在积极推进TQC3302的临 床开发，有望为COPD患者提供更多治疗选择。 中国生物制药(01177)发布公告，本集团自主研发的2.3类改良型新药TQC3302"ICS/LAMA/LABA软雾吸 入制剂"吸入喷雾剂已获得中国国家药品监督管理局(NMPA)的临床试验批准，拟用于慢性阻塞性肺疾病 (COPD)的维持治疗。 TQC3302是依托本集团软雾吸入技术平台开发的一款ICS(吸入性糖皮质激素)/LAMA(长效抗胆硷能药 物)/LABA(长效β2受体激动剂)三联复方制剂，已通过临床前研究证实了其三联组方的安全性。 ...

Core Viewpoint - China Biopharmaceutical (01177.HK) has received clinical trial approval from the National Medical Products Administration (NMPA) for its self-developed modified new drug TQC3302, intended for the maintenance treatment of chronic obstructive pulmonary disease (COPD) [1] Group 1: Product Development - TQC3302 is a combination formulation of ICS (Inhaled Corticosteroids), LAMA (Long-acting Muscarinic Antagonists), and LABA (Long-acting Beta-2 Agonists) developed on the company's soft mist inhalation technology platform [1] - The safety of the triple combination formulation has been confirmed through preclinical studies [1] Group 2: Technology and Benefits - The soft mist inhaler represents a new generation of inhalation devices, delivering medication in a slow mist form using mechanical power [1] - Compared to traditional nebulizers and dry powder inhalers, the soft mist inhaler allows for longer aerosol release time and slower speed, reducing drug loss in the oropharynx and increasing lung deposition rates [1] - This device requires lower hand-mouth coordination, making it suitable for difficult-to-treat populations such as children and the elderly [1]

（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 TQC3302「ICS/LAMA/LABA軟霧吸入制劑」 臨床試驗申請獲NMPA批准 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，本集團自 主研發的2.3類改良型新藥TQC3302「ICS/LAMA/LABA軟霧吸入制劑」吸入噴霧劑已獲得中國國家藥 品監督管理局(NMPA)的臨床試驗批准，擬用於慢性阻塞性肺疾病(COPD)的維持治療。 TQC3302是依托本集團軟霧吸入技術平台開發的一款ICS（吸入性糖皮質激素）╱LAMA（長效抗膽鹼 能藥物）╱LABA（長效β2受體激動劑）三聯復方制劑，已通過臨床前研究證實了其三聯組方的安全 性。 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。 軟霧吸入劑是新一代吸入劑型，利用機械動力以緩慢的細霧形式向患者遞送藥物。相較於傳統的霧 化、干粉等劑型，軟霧吸入 ...

8月4日，中国生物制药(01177)盘中下跌2.19%，截至10:03，报7.16元/股，成交3.03亿元。 截至2024年年报，中国生物制药营业总收入288.66亿元、净利润35.0亿元。 本文源自：金融界 作者：行情君 中国生物制药有限公司是一家创新研究和研发驱动型的医药集团，其主要业务包括医药研发、智能化生 产以及销售，主要产品包括多种生物药和化学药，特别在肿瘤、肝病、呼吸系统、外科/镇痛四大治疗 领域具有优势。公司自从2000年上市以来，在MSCI全球标准指数、恒生指数等多个指数中成为成分 股，连续六年入选《制药经理人》的"全球制药企业TOP50"，核心企业正大天晴药业集团、北京泰德制 药股份有限公司多年位列中国医药工业企业百强榜，公司产品收入占比逐年提升。 ...

Core Viewpoint - The company has made significant progress in its innovative transformation, focusing on drug development in oncology, liver disease/metabolism, respiratory, and surgical/pain management, with multiple pipelines showing potential for overseas licensing [1][2][3] Group 1: Innovation and R&D Investment - The company has increased its R&D investment to 17.6% of revenue in 2024, up from 9.9% in 2019 [2] - By the end of 2024, the company has received approval for 17 innovative drugs, with innovative product revenue accounting for 42% of total revenue, compared to 11% in 2015 [2] - The company has averaged over 3 License in transactions per year from 2019 to 2024, enhancing the richness of its innovative drug pipeline [2] Group 2: Product Pipeline and Market Potential - The oncology pipeline includes key products such as Anlotinib, which has received approval for 9 indications and has 4 additional indications submitted for NDA [3] - The company is advancing several promising products, including TQB2102 (HER2 dual antibody ADC) and TQC3721 (PDE3/4 inhibitor), which have significant potential for overseas licensing [3] - The company’s biosimilar drugs have a combined market capacity of 240 billion yuan in 2024, indicating strong growth potential [3][4] Group 3: Financial Projections and Valuation - The company expects revenue growth of 11.4%/10.5%/9.6% for 2025E/26E/27E, with adjusted net profit growth of 12.2%/11.5%/10.5% [4] - The target price is set at 9.40 HKD based on a 10-year DCF model, corresponding to a 37x adjusted PE for 2026 [4]