泰 勵 生 物 有 限 公 司 * 智通财经APP获悉，据港交所1月29日披露，泰励生物有限公司(简称：泰励生物)向港交所主板递交上市申请，中信证券为其独家保荐 人。招股书披露，泰励生物是一家成立于2017年的处于临床阶段的生物制药公司，专注于发现与开发创新肿瘤疗法。公司的药物组合包 含四种候选药物，包括一款处于2期临床试验阶段的核心产品7SN1611，一款额外临床阶段候选药物TSN222和两款临床前期候选药物 TSNA1789和TSNA3339。公司的核心候选药物TSN1611是一款高选择性的口服KRAS G12D抑制剂。KRAS G12D作为最常见的致感驱动突 变之一，在历史上始终是治疗难点。TSN1611目前正在美国及中国开展2期临床试验，并计划在中国推进用于治疗非小细胞肺癌 （「NSCLC」）的关键性注册临床试验。 Tyligand Bioscience Ltd. 4 中信证券 (於開曼群島註冊成立的有限公司) 「編纂]的「編纂]股份數目 : 「編纂]股股份(視乎[編纂]行使與否而定) 「編纂]數目 「編纂」股股份(可予重新分配) ·· 國際[編纂]數目 . 「編纂]股股份(可予重新分配及視乎[編 纂 ...

Group 1 - The core viewpoint of the articles highlights the recent approvals of innovative drugs by HeYu Pharmaceutical, including the first systemic treatment for tenosynovial giant cell tumor (TGCT) in China and a KRAS G12D inhibitor for clinical trials [1][2] Group 2 - HeYu Pharmaceutical's CSF-1R inhibitor, Beijiemai (pimitinib hydrochloride capsules), has received approval from the National Medical Products Administration (NMPA), marking it as the first systemic treatment for TGCT in China [1] - The KRAS G12D inhibitor, ABSK141, has also received NMPA approval for an open-label Phase I/II clinical trial to evaluate its safety, tolerability, efficacy, and pharmacokinetics in patients with advanced solid tumors carrying the KRAS G12D mutation [1] - Preliminary data from the Phase II clinical study of the oral PD-L1 inhibitor ABSK043 in combination with the EGFR inhibitor Furmonertinib for non-small cell lung cancer (NSCLC) shows good safety and tolerability, with no observed dose-limiting toxicities or interstitial lung disease [2] - Revenue forecasts for HeYu Pharmaceutical are projected at 612.1 million, 678.8 million, and 627.2 million yuan for 2025-2027, reflecting year-on-year growth rates of 21.5%, 10.9%, and -7.6% respectively, with the current stock price corresponding to price-to-sales ratios of 13.0, 11.7, and 12.7 [2]

Investment Rating - The report maintains a "Buy" rating for the company, indicating a strong expectation for future returns exceeding the market benchmark by over 20% within the next 6-12 months [5][10]. Core Insights - The approval of the CSF-1R inhibitor, Beijiemai® (pimitinib), by the NMPA marks a significant milestone as it is the first systemic treatment for tenosynovial giant cell tumor (TGCT) in China and the first independently developed drug in this category [1][5]. - The clinical trial application for the KRAS G12D inhibitor, ABSK141, has also been approved, with an open-label I/II phase study aimed at evaluating its safety and efficacy in patients with advanced solid tumors carrying the KRAS G12D mutation [1]. - Preliminary data from the Phase II clinical study of the oral PD-L1 inhibitor, ABSK043, in combination with the EGFR inhibitor, furmonertinib, for treating non-small cell lung cancer (NSCLC) shows good safety and tolerability [2]. Financial Projections - Revenue forecasts for the company are as follows: 2025 revenue is projected at 612.1 million, 2026 at 678.8 million, and 2027 at 627.2 million, reflecting growth rates of 21.5%, 10.9%, and -7.6% respectively [4][9]. - The net profit attributable to the parent company is expected to reach 82.2 million in 2025, 133.8 million in 2026, and 98.4 million in 2027, with significant growth rates of 190.5% and 62.7% for 2025 and 2026 respectively [4][9]. - The earnings per share (EPS) is projected to be 0.12 in 2025, 0.20 in 2026, and 0.14 in 2027, indicating a positive trend in profitability [4][9].

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，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容引致的任何損失承擔任何責任。 GenFleet Therapeutics (Shanghai) Inc. 勁方醫藥科技（上海）股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2595） 自願公告 GFH375治療轉移性胰腺癌註冊性臨床試驗在首家研究中心啟動， 為全球首個口服KRAS G12D抑制劑單藥對照化療III期研究 本公告由勁方醫藥科技（上海）股份有限公司（「本公司」或「勁方」，連同其附屬公 司統稱「本集團」）自願刊發，以知會本公司股東及潛在投資者有關本集團最新業 務動態。 本公司董事會欣然宣佈，口服KRAS G12D (ON/OFF)抑制劑GFH375治療經治 KRAS G12D突變型轉移性胰腺癌患者的註冊性III期試驗(GFH375X1301)已在北 京大學腫瘤醫院啟動。目前GFH375開發進度位於全球口服KRAS G12D抑制劑第 一梯隊，多項GFH375（於中國境外稱VS-7375）單藥和聯合療法正在 ...

Core Viewpoint - The company announced that its subsidiary, Shanghai Heyu Biopharmaceutical Technology Co., Ltd., has received FDA approval for the IND application of a new oral, highly active, and selective small molecule KRAS G12D inhibitor, ABSK141, aimed at treating patients with advanced solid tumors carrying the KRAS G12D mutation [1] Group 1 - The new drug ABSK141 targets advanced solid tumors with KRAS G12D mutations [1] - The FDA approval marks a significant milestone for the company's research and development efforts in oncology [1] - The development of ABSK141 reflects the growing focus on targeted therapies in cancer treatment [1]

Verastem FY Conference Summary Company Overview - **Company**: Verastem (NasdaqCM: VSTM) - **Industry**: Biotechnology, specifically focused on oncology treatments Key Points Commercial Launch in LGSC - Verastem reported strong sales in Q3, indicating good commercial momentum in the launch of their product for Low-Grade Serous Carcinoma (LGSC) [3][4] - The sales force is focused on identifying patients and working with clinical sites to optimize treatment [4][5] - The company aims to keep patients on treatment for an extended duration, with an average treatment duration of 18 months observed in clinical trials [5][6] - Initial patient distribution shows over half coming from large academic centers, with a notable amount from community settings [7][9] Patient Identification and Treatment Strategy - The launch strategy targets 100 institutions where the majority of patients are concentrated [9][10] - Verastem has established partnerships with specialty pharmacies and group purchasing organizations to enhance distribution [10][11] - The company is not planning to expand its sales force, believing current resources are sufficient [11] Off-Label Use and Clinical Data - Majority of prescriptions are for KRAS mutant patients, but some off-label use for KRAS wild-type patients is occurring without reimbursement issues [12][13] - Recent studies indicate a survival advantage for using MEK inhibitors, reinforcing the treatment's efficacy [13][14] NCCN Guidelines and Revenue Guidance - Verastem submitted for NCCN guideline inclusion, with updates expected after the new year [15][16] - The company is cautious about providing revenue guidance, preferring to wait until they have more predictable data [18][19] RAMP 301 Study Adjustments - The RAMP 301 study has seen a slight adjustment in patient enrollment due to a faster-than-expected accrual rate [20][21] - The study's interim analysis suggested adding a small number of patients to ensure robust data collection [22][23] - The final accrual is projected to finish in Q1, with top-line data expected in the second half of 2027 [28][29] Total Addressable Market (TAM) - The total addressable market for LGSC is estimated at $4 billion, with projected peak sales ranging from $200 million to over $600 million [30][31] Pipeline Drug: VS-7375 (KRAS G12D Inhibitor) - VS-7375 is positioned as a best-in-class dual inhibitor, with promising phase I data showing a 69% response rate in lung cancer and 58% in second-line pancreatic cancer [33][41] - The company is focusing on improving tolerability in its U.S. trials by using fed patients and prophylactic antiemetics [42][44] - Ongoing combination studies with other therapies are being explored to enhance treatment efficacy [49][50] Collaboration with GenFleet - Verastem is leveraging data from GenFleet, which holds rights in China, to expedite its own clinical programs [51][52] - Regular collaboration and data sharing are expected to enhance the development of both companies' pipelines [52][53] Additional Insights - The company is optimistic about the potential for accelerated approval paths based on the strong efficacy data observed [41] - There is a growing awareness of LGSC, which may lead to increased patient identification and treatment opportunities [31]

Core Insights - The company has initiated the clinical trial of GFH375, a KRAS G12D inhibitor, for treating advanced solid tumors, marking a significant step in its clinical development [1][2] - The trial, approved by the National Medical Products Administration, aims to evaluate the safety, efficacy, and pharmacokinetics of GFH375 in combination with chemotherapy and cetuximab [1] - GFH375 has shown promising results in preclinical studies and has received fast track designation from the FDA for treating advanced KRAS G12D mutant pancreatic ductal adenocarcinoma (PDAC) [2] Group 1 - GFH375's clinical trial (GFH375X1202) has commenced with the first patient enrolled at Peking University Cancer Hospital [1] - The trial will be conducted at approximately 15 centers, focusing on the safety and efficacy of GFH375 in combination with either cetuximab or chemotherapy [1] - The Phase II trial will specifically target first-line treatment for advanced PDAC and colorectal cancer (CRC) patients [1] Group 2 - Dr. Wang Yu, Chief Medical Officer, expressed optimism about advancing GFH375 into frontline PDAC treatment, highlighting its potential across multiple tumor types [2] - The single-agent study of GFH375 is set to begin in June 2024, with promising data already presented at major oncology conferences [2] - GFH375 is a highly selective oral small molecule that inhibits KRAS G12D, effectively disrupting downstream signaling pathways and tumor cell proliferation [2] Group 3 - The company has entered into a licensing and early collaboration agreement with Verastem for three RAS/MAPK-driven cancer products [3] - Verastem has chosen GFH375/VS-7375 as the lead project, granting them exclusive rights outside Greater China upon achieving specific clinical milestones [3] - The licensing agreement allows Verastem to develop and commercialize GFH375 outside of China, while the company retains rights within the country [3]

Core Insights - GFH375, a KRAS G12D inhibitor, has entered clinical trials for treating advanced solid tumors, marking a significant step in its development [1][2] - The study, GFH375X1202, received approval from the National Medical Products Administration in September and involves combination therapies with cetuximab or chemotherapy [1] - The primary objective of the trial is to assess the safety, tolerability, efficacy, and pharmacokinetics of GFH375 in patients with solid tumors [1] Group 1 - The first patient has been enrolled in the Ib/II phase study at Peking University Cancer Hospital [1] - The Ib phase will be conducted at approximately 15 centers, focusing on the safety and efficacy of GFH375 in combination with cetuximab or chemotherapy [1] - The II phase will specifically target first-line treatment for advanced pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC) patients [1] Group 2 - Dr. Wang Yu, Chief Medical Officer of the company, expressed optimism about advancing GFH375's clinical development from later lines to first-line treatment for PDAC [2] - Recent data on GFH375's monotherapy for PDAC and non-small cell lung cancer (NSCLC) were presented at ESMO and WCLC, indicating promising efficacy across multiple tumor types [2] - The company anticipates rapid progress in both domestic and international studies based on GFH375, aiming to benefit patients soon [2]

Core Insights - The company has initiated the clinical trial of GFH375 in combination therapies for treating KRAS G12D mutant advanced solid tumors, marking a significant step in its clinical development [1][2] Group 1: Clinical Trials and Research - GFH375 has received approval for clinical trials from the National Medical Products Administration, with the first patient enrolled at Peking University Cancer Hospital [1] - The trial (GFH375X1202) will evaluate the safety, tolerability, efficacy, and pharmacokinetics of GFH375 in combination with cetuximab or chemotherapy in approximately 15 centers [1] - The Ib phase will focus on assessing the combination of GFH375 with chemotherapy as a first-line treatment for pancreatic ductal adenocarcinoma (PDAC) [1] Group 2: Product Development and Efficacy - GFH375 is an oral, highly selective small molecule KRAS G12D inhibitor that disrupts the activation of downstream pathways, effectively inhibiting tumor cell proliferation [2] - Clinical data for GFH375 as a monotherapy for PDAC and non-small cell lung cancer (NSCLC) has shown promising efficacy, with recent presentations at ESMO and WCLC [2] - The drug has been granted FDA Fast Track designation for use in treating locally advanced and metastatic KRAS G12D mutant PDAC patients [2] Group 3: Strategic Partnerships - The company has entered into a licensing and early collaboration agreement with Verastem for three products related to RAS/MAPK-driven cancers [3] - Verastem has chosen GFH375/VS-7375 as the lead project, granting them exclusive rights for development and commercialization outside Greater China, while the company retains rights within China [3]

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，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容引致的任何損失承擔任何責任。 GenFleet Therapeutics (Shanghai) Inc. 勁方醫藥科技（上海）股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2595） 勁方與Verastem就勁方開發的三款有關RAS/MAPK驅動癌症的產品達成了授權及 早期合作開發協議。該合作賦予Verastem獨家選擇權，以就該等三款產品在成功 達成I期臨床試驗預先設定的里程碑後獲得各自許可。於2023年12月，Verastem 選擇GFH375/VS-7375（一款口服KRAS G12D(ON/OFF)抑制劑）作為其合作的 領頭項目，就GFH375獲得的許可乃該合作誕生的第一個許可。該等許可將賦予 Verastem在大中華區外的開發和商業化權利，而勁方保留中國境內的該等權利。 自願公告 KRAS G12D抑制劑GFH375聯合西妥昔單抗或化療治療 晚期實體瘤的Ib/II期研究完成首例患者給藥， 適應症涵蓋一線 ...