Core Viewpoint - China Biologic Products (01177) has seen a stock increase of over 4%, currently trading at 7.09 HKD with a transaction volume of 431 million HKD, as reported by UBS [1] Group 1: Business Development - The management of China Biologic Products indicated that more time is needed to finalize the guidance for its out-licensing (BD) business for this year [1] - Key data results expected this year include Phase I clinical data for TQB3702 in blood cancer, Phase II clinical data for TQA3334, and Phase III clinical data for lanifibranor targeting metabolic-associated fatty liver disease [1] Group 2: Market Outlook - The management is optimistic about the inclusion prospects of VIIa in the 2025 National Medical Insurance Drug List negotiations, as only three companies are selected for inclusion [1] - Penpulimab has successfully entered the medical insurance list for the first time, while anlotinib has been approved for expansion to first-line treatment of soft tissue sarcoma without any price reduction [1] - Yilishu benefits from an expanded reimbursement scope [1] Group 3: Product Information - The VIIa product is the recombinant human coagulation factor VIIa N01 (brand name: Anqixin) developed by China Biologic Products' subsidiary, which received NMPA approval for market entry on July 3, 2025 [1] - This product is the first domestically produced recombinant human coagulation factor VIIa biological product, breaking the long-standing monopoly of imported products, improving drug accessibility for hemophilia patients, and reducing treatment costs [1]

Core Viewpoint - China Biologic Products (01177) has seen a stock increase of over 4%, currently trading at 7.09 HKD with a transaction volume of 431 million HKD. UBS reports that the management requires more time to finalize the guidance for the business development of external authorization (BD) this year [1] Group 1: Clinical Data and Product Development - The company is expected to announce clinical data results this year, including Phase I clinical data for TQB3702 in blood cancer, Phase II clinical data for TQA3334, and Phase III clinical data for lanifibranor targeting metabolic-associated fatty liver disease [1] - Management is optimistic about the inclusion prospects of VIIa in the 2025 National Medical Insurance Drug List negotiations, as only three companies have been selected for inclusion [1] Group 2: Recent Approvals and Market Impact - Penpulimab has successfully entered the medical insurance catalog for the first time, while anlotinib has been approved for expansion to first-line treatment of soft tissue sarcoma without any price reduction [1] - Yilishu benefits from an expanded reimbursement scope, enhancing its market accessibility [1] Group 3: Product Significance - The VIIa product, developed by the company's subsidiary, is the first domestically produced recombinant human coagulation factor VIIa (brand name: Anqixin), which received NMPA approval on July 3, 2025 [1] - This product breaks the long-standing monopoly of imported products, improving medication accessibility for hemophilia patients and reducing treatment costs [1]

Group 1 - The core point of the news is that China Biologic Products (01177.HK) has seen significant insider buying from its executive director, demonstrating confidence in the company's long-term development [1] - Executive Vice President Xie Xin purchased 1 million shares at an average price of HKD 6.4068 per share, totaling approximately HKD 6.4068 million, increasing his holdings to 361 million shares, representing 1.92% of the company [1] - This marks Xie Xin's third purchase since July 2025, with previous purchases made at average prices of HKD 6.47 and HKD 7.36, indicating a total investment of over HKD 20 million in the past six months [1] Group 2 - The mid-year report for 2025 indicates that China Biologic Products' innovative transformation is showing significant results, with expectations that revenue from innovative products will exceed 50% of total revenue [2] - The company has achieved several milestones since December last year, including the approval of the breast cancer innovative drug Kemosil capsules, which is the world's first CDK2/4/6 inhibitor [2] - Other notable advancements include the clinical application approvals for the oral GLP-1 receptor agonist TQF3250 for weight loss by both the NMPA and FDA, and positive progress in the phase II clinical trial of the TYK2/JAK1 inhibitor TQH3906 for plaque psoriasis [2]

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12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: 2026年1月2日 I. 法定/註冊股本變動 FF301 II. 已發行股份及/或庫存股份變動 | 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, ...

Core Viewpoint - China Biologic Products (01177.HK) has announced that its self-developed TDI01, a ROCK2 inhibitor for the treatment of idiopathic pulmonary fibrosis (IPF), has completed the enrollment of its first patient in a Phase III clinical trial, marking it as the world's first high-selectivity ROCK2 inhibitor to enter Phase III for IPF [1] Group 1: Product Development - TDI01 is a highly selective ROCK2 kinase inhibitor achieved through structural innovation, targeting the vascular secretion system, which is crucial for regulating vascular leakage, fibrosis, inflammation, and immune disorders [1] - The high selectivity of TDI01 for ROCK2 is expected to optimize the drug's safety profile and potentially provide clinical benefits superior to existing standard therapies [1] Group 2: Clinical Trial Results - Phase II clinical trial data showed that after 24 weeks of treatment, patients in the TDI01 400mg group experienced an improvement of 89mL in forced vital capacity (FVC) compared to the placebo group, significantly reducing the risk of all-cause mortality [1] - TDI01 also effectively reduced the risk of acute exacerbation and progression of IPF, with a lower incidence of serious adverse events and drug discontinuation due to adverse events compared to standard treatment options, demonstrating good safety and tolerability [1]

Core Viewpoint - China Biopharmaceutical (01177) has announced that its self-developed TDI01 "ROCK2 inhibitor" for the treatment of idiopathic pulmonary fibrosis (IPF) has completed the enrollment of its first patient in a Phase III clinical trial, marking it as the world's first high-selectivity ROCK2 inhibitor to enter Phase III clinical trials for IPF [1] Group 1 - TDI01 is a highly selective ROCK2 kinase inhibitor achieved through structural innovation, targeting the vascular secretion system, which is crucial for regulating vascular leakage, fibrosis, inflammation, and immune disorders, thereby intervening in the complex pathogenesis of IPF from multiple dimensions [1] - The high selectivity of TDI01 for ROCK2 is expected to optimize the drug's safety window and potentially provide clinical benefits superior to existing standard therapies [1] Group 2 - Phase II clinical trial data shows that after 24 weeks of treatment, patients in the TDI01 400mg group experienced an improvement of 89mL in forced vital capacity (FVC) compared to the placebo group, significantly reducing the risk of all-cause mortality and effectively lowering the risk of acute exacerbation and progression of IPF [1] - In terms of safety, the incidence of serious adverse events and the rate of discontinuation due to adverse events in the TDI01 treatment group were lower than those of similar standard treatment drugs, demonstrating TDI01's good safety and tolerability profile [1]

Core Viewpoint - China Biopharmaceutical (01177) has announced that its self-developed TDI01 "ROCK2 inhibitor" for the treatment of idiopathic pulmonary fibrosis (IPF) has completed the enrollment of its first patient in a Phase III clinical trial, marking it as the world's first ROCK2 high-selectivity inhibitor to enter Phase III clinical trials for IPF [1] Group 1: Product Development - TDI01 is a highly selective ROCK2 kinase inhibitor achieved through structural innovation, targeting the vascular secretion system, which is crucial for regulating vascular leakage, fibrosis, inflammation, and immune disorders [1] - The high selectivity of TDI01 for ROCK2 is expected to optimize the drug's safety window and potentially provide clinical benefits superior to existing standard therapies [1] Group 2: Clinical Trial Results - Phase II clinical trial data indicates that after 24 weeks of treatment, patients in the TDI01 400mg group experienced an improvement of 89mL in forced vital capacity (FVC) compared to the placebo group, significantly reducing the risk of all-cause mortality [1] - TDI01 also effectively reduces the risk of acute exacerbation and progression of IPF, with the incidence of serious adverse events and discontinuation rates due to adverse events in the TDI01 treatment group being lower than those of standard treatment drugs, demonstrating good safety and tolerability [1]

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。 1 IPF是一種病因和發病機制尚不明確、進行性的慢性纖維化間質性肺病，隨著病情進展，患者的肺功 能逐步喪失，最後可能因肺部組織疤痕密佈而死於呼吸衰竭，影響著全球約300萬人[1]。IPF的發病率 和患病率呈逐年增加趨勢，發病人群以老年人為主，患者中位生存期僅為2-3年[2]。然而，現有藥物 無法控制或逆轉已受損的肺功能，且存在光敏反應、肝損傷及腹瀉等明顯不良反應，臨床亟需能夠 綜合干預疾病複雜機制且安全性更優的新型療法。 （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 TDI01「ROCK2抑制劑」特發性肺纖維化Ⅲ期 臨床試驗完成首例患者入組 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TDI01「ROCK2抑制劑」用於治療特發性肺纖維化(IPF)的Ⅲ期臨床試驗，已完成首例 ...

Core Viewpoint - China Biopharmaceutical (01177) announced that its self-developed innovative drug TQH3906, a TYK2/JAK1 JH2 allosteric inhibitor, has completed Phase II clinical trials for moderate to severe plaque psoriasis, demonstrating good safety and efficacy [1][2]. Group 1: Clinical Trial Results - TQH3906 showed good safety and tolerability across all dosage groups, achieving the primary endpoint of the Phase II study [1]. - The study was a randomized, double-blind, placebo-controlled, multi-center trial involving 209 patients, with a daily oral administration regimen [1]. - At the recommended Phase II dose (RP2D), after 12 weeks of treatment, the PASI75 response rate exceeded 90% and the PASI90 response rate exceeded 70%, significantly outperforming the placebo group, which had PASI75 and PASI90 response rates of approximately 10% and 5%, respectively [2]. Group 2: Efficacy and Safety Comparison - The efficacy level of TQH3906 is comparable to IL-17/IL-23 targeted biologics and shows superior efficacy compared to other marketed oral psoriasis treatments like Deucravacitinib and Apremilast [2]. - The overall safety profile of TQH3906 is good, with the incidence of adverse events similar to the placebo group, and most treatment-emergent adverse events (TEAEs) were of grade 1-2 severity [2]. - No new safety signals were observed, and the safety characteristics are similar to other TYK2 inhibitors [2]. Group 3: Market Context and Future Research - Oral small molecule targeted therapies like TQH3906 offer advantages over antibody-based biologics, including convenience of administration, high tolerability, and better patient compliance [3]. - Currently, the only approved oral small molecule drugs for plaque psoriasis in China are PDE-4 inhibitors and Deucravacitinib, which have lower PASI75 and PASI90 response rates compared to TQH3906 [3]. - TQH3906 targets the pseudo-kinase domain (JH2) of TYK2/JAK1, enhancing selectivity against JAK2, JAK3, and other kinases, potentially leading to better safety profiles [3]. - The company plans to explore TQH3906 for new indications in inflammatory bowel disease, psoriatic arthritis, and other autoimmune and dermatological conditions [3].

Core Viewpoint - China Biopharmaceutical's innovative drug TQH3906 has successfully completed Phase II clinical trials for moderate to severe plaque psoriasis, demonstrating good safety and efficacy profiles [1][2]. Group 1: Clinical Trial Results - TQH3906 achieved its primary endpoint in the Phase II study, which included 209 patients across multiple dosage groups and a placebo group, administered orally once daily [1]. - The drug showed a dose-response relationship, with over 90% achieving PASI 75 and over 70% achieving PASI 90 after 12 weeks of treatment at the recommended Phase II dose, significantly outperforming the placebo group [2]. Group 2: Safety Profile - The overall safety of TQH3906 was good, with the incidence of adverse events comparable to the placebo group, and most adverse events were of mild to moderate severity [2]. - No new safety signals were identified, and the safety profile was similar to other TYK2 inhibitors [2]. Group 3: Market Context and Advantages - Oral small molecule targeted therapies like TQH3906 offer advantages over antibody-based biologics, including ease of administration, better tolerability, and improved patient compliance [3]. - Current oral treatments for plaque psoriasis have lower efficacy rates, with PASI 75 and PASI 90 response rates around 60% and 40%, respectively, highlighting the need for more effective and safe oral medications [3]. - TQH3906 targets the pseudokinase domain (JH2) of TYK2/JAK1, enhancing selectivity compared to traditional JAK inhibitors, which may lead to better safety profiles [3].