Group 1 - China Biologic Products (01177.HK) announced that its subsidiary, Chengda Tianqing, has completed the interim analysis of the Phase III clinical study for TQB3454, an IDH1 inhibitor for advanced cholangiocarcinoma with IDH1 mutations, achieving the predefined efficacy thresholds for progression-free survival (PFS) and overall survival (OS) [1] - The study, TQB3454-III-01, is a randomized, double-blind, placebo-controlled, multi-center Phase III trial aimed at evaluating the efficacy and safety of TQB3454 in patients with advanced cholangiocarcinoma who have failed previous treatments [1] - The independent data monitoring committee (IDMC) determined that TQB3454 significantly reduces the risk of disease progression or death compared to the control group, significantly extending both PFS and OS [1] Group 2 - Cholangiocarcinoma (BTC) accounts for approximately 3% of all digestive system tumors, with over 200,000 new cases globally in 2021, and its incidence is on the rise [2] - BTC primarily consists of adenocarcinoma, characterized by high malignancy and poor prognosis, with a five-year survival rate of less than 5% [2] - IDH1 inhibitors are crucial for the precision treatment of cholangiocarcinoma, and currently, there are no approved drugs targeting this pathway in China, indicating a significant unmet clinical need [2]

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。 自願公告 TQB3454「IDH1抑制劑」膽道癌III期臨床研究取得陽性結果 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 附屬公司正大天晴藥業集團股份有限公司（「正大天晴」）自主研發的國家1類創新藥TQB3454「IDH1抑 制劑」治療伴IDH1突變晚期膽道癌III期臨床研究已完成方案預設的期中分析，獨立數據監查委員會 (IDMC)判定主要研究終點無進展生存期(PFS)、總生存期(OS)均達到方案預設的優效界值。本集團已 與中國國家藥品監督管理局藥品審評中心(CDE)就該適應症的上市申請進行溝通，並獲得CDE書面同 意，將於近期遞交上市申請。這是全球第2個、國內第1個IDH1抑制劑在膽道癌取得成功的III期臨床 研究。 1 膽道癌(BTC)主要包括膽管癌和膽囊癌，約佔所有消化系腫瘤的3%，2021年全球新發患者數量超過 20萬，且發病率呈上升趨勢[1 ...

Summary of Nuvation Bio Conference Call Company Overview - **Company**: Nuvation Bio (NYSE:NUVB) - **Industry**: Biotechnology - **Key Products**: - Ibtrozi (ROS1 inhibitor) - Safucitinib (IDH1 inhibitor for gliomas) Key Points and Arguments Ibtrozi Performance - Ibtrozi received FDA approval in June and had 204 new patient starts in its first full quarter, significantly exceeding expectations [2][3] - The ROS1 market is estimated at 3,000 new patients annually, expected to rise to 4,000 with RNA testing [3][15] - Ibtrozi's response rate is reported at 90%, with a progression-free survival (PFS) of 50 months, which is unprecedented in solid tumors [4][5] - The discontinuation rate for adverse events is only 0.3%, indicating high tolerability [4][5] - Revenue potential is substantial, with estimates ranging from $220 million to $2 billion annually based on patient mix and treatment lines [8][9] Market Dynamics - The NCCN guidelines have shifted to favor ROS1 agents over IO chemotherapy, enhancing Ibtrozi's market position [12] - Ibtrozi has achieved 80% life coverage with no step edits, facilitating patient access [13][14] - RNA NGS sequencing is expected to increase the annual incidence of ROS1 by 30% [15] Competitive Landscape - Nuvation Bio's drug is positioned favorably against competitors, with superior response rates and a broader patient population [22][23] - The company is the only ROS1 agent currently in an adjuvant study, which is expected to enhance its market share [19] Safucitinib Development - New data for Safucitinib shows a 44% overall response rate and an 88% 24-month landmark PFS, significantly outperforming the competitor vorasidenib [24][25] - A pivotal study is underway, including both high-grade and low-grade glioma patients [26][27] Financial Position and Future Outlook - Nuvation Bio has a strong cash position of $549 million, sufficient to reach profitability [35] - The company is exploring business development opportunities and partnerships, particularly in the ex-U.S. market [20][31] - Key catalysts for the upcoming year include sales growth, European partnership announcements, and advancements in clinical studies [36] Strategic Acquisitions - The company raised $200 million for business development, indicating a focus on strategic acquisitions in the biotech space [31][33] Additional Important Information - The company is not pursuing a head-to-head study against vorasidenib due to its superior data, which is seen as a prudent financial decision [25] - The anticipated timeline for pivotal study data is expected to read out by 2029, with potential for earlier interim results [27] This summary encapsulates the critical insights from the Nuvation Bio conference call, highlighting the company's strategic positioning, product performance, and future growth potential in the biotechnology sector.