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].

Core Viewpoint - China Biologic Products (01177.HK) has announced the completion of Phase II clinical trials for its self-developed innovative drug TQH3906, a TYK2/JAK1 JH2 allosteric inhibitor, targeting moderate to severe plaque psoriasis, demonstrating good safety and tolerability across all dosage groups and achieving the primary endpoint of the study [1] Group 1: Clinical Trial Details - The study is a randomized, double-blind, placebo-controlled, multi-center Phase II trial (NCT06542614) aimed at evaluating the efficacy and safety of TQH3906 in patients with moderate to severe plaque psoriasis [1] - A total of 209 patients were enrolled in the study, which included a placebo group and five different dosage groups of TQH3906 [1] - The drug was administered orally once daily throughout the trial [1]

TQH3906「TYK2/JAK1 JH2變構抑制劑」 斑塊狀銀屑病二期取得積極進展 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 主研發的國家1類創新藥TQH3906「TYK2/JAK1 JH2變構抑制劑」已於近日完成針對中重度斑塊狀銀屑 病(PsO)的二期臨床試驗。研究結果顯示，TQH3906所有劑量組均表現出良好的安全性與耐受性，並 達到二期研究的主要終點。 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 在安全性方面，TQH3906整體安全性良好，總體不良事件發生率與安慰劑組相當，且絕大部分治療 期間出現的不良事件(TEAE)嚴重程度為1-2級。其安全性特徵與同類TYK2抑制劑的表現相似，未出 現新的安全性信號。 相比抗體類生物制劑，口服小分子靶向藥物具有給藥便捷、耐受性高及 ...

智通财经APP获悉，香港联交所最新资料显示，12月24日，副总裁兼执行董事谢炘增持中国生物制药 (01177)100万股，每股作价6.4068港元，总金额为640.68万港元。增持后最新持股数目约为3.61亿股，最 新持股比例为1.92%。 ...

香港联交所最新资料显示，12月24日，副总裁兼执行董事谢炘增持中国生物制药(01177)100万股，每股 作价6.4068港元，总金额为640.68万港元。增持后最新持股数目约为3.61亿股，最新持股比例为1.92%。 ...

Core Viewpoint - The report from Bank of America indicates a significant decline in the sales of the pharmaceutical industry in mainland China for October, with a year-on-year decrease of 3%, contrasting sharply with a 6.8% increase in September [1] Industry Summary - The hospital channel experienced a year-on-year decline of 3.3%, down from a previous growth of 7.1% [1] - The retail channel remained nearly flat year-on-year, showing a notable slowdown from a 2.4% increase in September [1] Company Performance - The performance of China's biopharmaceutical products in October showed a mixed trend, with core products anlotinib and glycyrrhizic acid seeing year-on-year sales growth of 6.5% and 4.4%, respectively [1] - Conversely, sales of budesonide and esomeprazole fell significantly, with year-on-year declines of 28.5% and 39.4%, respectively [1] Revenue Forecast Adjustments - Based on the sales performance, the company has revised its revenue forecasts for 2026 and 2027 downwards by 0.2% and 0.4%, respectively [1] - The target price has been adjusted from HKD 9.4 to HKD 8.3, while maintaining a "Buy" rating due to the substantial licensing potential of pipeline products [1] Specific Company Ratings - For CSPC Pharmaceutical, the report notes continued poor sales performance of several key drugs in October, leading to a maintained "Underperform" rating with a target price of HKD 7.2 [1]

中国生物制药(01177.HK)公布，集团自主研发的国家1类创新药库莫西利胶囊 (商品名：赛坦欣®) 已获 得中国国家药品监督管理局 (NMPA) 的上市批准，用于与氟维司群联合治疗既往接受内分泌治疗后出现 疾病进展的激素受体 (HR) 阳性、人表皮生长因子受体2 (HER2) 阴性的局部晚期或转移性乳腺癌患者。 本文源自：金融界AI电报 ...