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獲得國內首個KRAS G12D抑制劑治療 非小細胞肺癌的突破性療法認定 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。 關於GFH375/VS-7375 GFH375為口服高活性、高選擇性小分子KRAS G12D(ON/OFF)抑制劑，通過非共 價形式結合KRAS G12D蛋白，抑制其與下游效應蛋白結合，從而在細胞中破壞 KRAS G12D對下游通路的持續活化，最終高效抑制腫瘤細胞增殖。臨床前研究 已顯示GFH375單藥對腫瘤生長的抑制效應隨用藥劑量和週期增長而提升，且在 激酶選擇性和安全性靶點測試 ...

Core Viewpoint - Tyligand Biosciences is a clinical-stage biopharmaceutical company focused on developing innovative cancer therapies, planning to list on the Hong Kong Stock Exchange under the 18A rule with a primary focus on small molecule drugs and ADC candidates [1][3]. Financial Performance - The company reported revenues of approximately RMB 0.08 billion for 2024 and RMB 0.11 billion for the first nine months of 2025, reflecting a year-on-year increase of 654.18% [4]. - The net losses were RMB 0.70 billion in 2024 and RMB 1.23 billion in the first nine months of 2025, with a year-on-year increase of 335.23% [4]. - Gross margins were reported at 90.64% for 2024 and 78.31% for the first nine months of 2025 [4]. - Research and development expenses were RMB -0.73 billion for 2024 and RMB -0.91 billion for the first nine months of 2025, with a year-on-year increase of 80.62% [4]. Drug Development Pipeline - The company has a drug portfolio that includes four candidates, with TSN1611 being the core product currently in Phase 2 clinical trials in the US and China for non-small cell lung cancer (NSCLC) [1][3]. - TSN1611 is a highly selective oral KRAS G12D inhibitor, with plans for a pivotal registration trial in China [1]. Industry Overview - The global market for KRAS G12D inhibitors is projected to grow from USD 81.8 million in 2027 to USD 3,481.6 million by 2035, with a compound annual growth rate (CAGR) of 59.8% [8]. - The Chinese market for KRAS G12D inhibitors is expected to increase from USD 12.3 million in 2027 to USD 446.5 million by 2035, with a CAGR of 56.7% [8][9]. Competitor Analysis - Comparable companies in the industry include Jinfang Pharmaceutical-B, Hengrui Medicine, and Revolution Medicines, with varying IPO details and financial metrics [12]. - Tyligand Biosciences has a current gross margin of 90.64%, which is competitive within the industry [12]. Management and Shareholding Structure - The board of directors consists of five members, including two executive directors and three non-executive directors [13]. - Major shareholders include Tyligand Holdings, which holds 23.66% of the company, with significant stakes from other investors such as Tencent and Kangzhe Pharmaceutical [15]. Financing History - The company has undergone multiple rounds of financing, with the latest B round valuing the company at approximately USD 222.2 million [17].

Core Viewpoint - Heng Rui Medicine's HRS-4642 injection has been included in the list of breakthrough therapies by the National Medical Products Administration, targeting advanced or metastatic pancreatic cancer with KRAS G12D mutation [1] Group 1: Product Development - HRS-4642 is a self-developed KRAS G12D inhibitor in a liposomal formulation [1] - The product is intended for use in combination with gemcitabine and albumin-bound paclitaxel as a first-line treatment [1] - Currently, there are no similar drugs approved for market domestically or internationally [1] Group 2: Market Context - Pancreatic cancer is a common malignant tumor of the digestive system, with 510,566 new cases reported globally in 2022, ranking 12th among malignant tumors [1] - The disease resulted in 467,005 deaths in 2022, making it the 6th leading cause of cancer-related deaths, accounting for approximately 5% of global cancer mortality [1]

Core Viewpoint - Heng Rui Medicine's HRS-4642 injection has been included in the list of breakthrough therapies by the National Medical Products Administration, targeting first-line treatment for advanced or metastatic pancreatic cancer with KRAS G12D mutation [1] Group 1: Product Development - HRS-4642 is a liposomal formulation KRAS G12D inhibitor that specifically binds to KRAS G12D, inhibiting the phosphorylation of MEK and ERK proteins to exert anti-tumor effects [1] - The total R&D investment for the related project has reached approximately 254 million yuan [1] Group 2: Regulatory and Market Context - The inclusion in the breakthrough therapy list indicates potential expedited development and approval processes, which may enhance market opportunities for the product [1] - Drug development is subject to various uncertainties related to technology, approval, and policy factors [1]

Group 1 - Tyligand Bioscience Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with CITIC Securities as the sole sponsor [1][3] - The company, established in 2017, is a clinical-stage biopharmaceutical firm focused on discovering and developing innovative cancer therapies [1] - Tyligand's drug portfolio includes four candidate drugs, with the core product TSN1611 being a selective oral KRAS G12D inhibitor currently in Phase 2 clinical trials in the US and China [1] Group 2 - TSN1611 targets the KRAS G12D mutation, which is one of the most common oncogenic driver mutations and has historically been challenging to treat [1] - The company plans to advance TSN1611 into pivotal registration clinical trials in China for the treatment of non-small cell lung cancer (NSCLC) [1]

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]