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 ...

和誉-B(02256)发布公告，公司的附属公司上海和誉生物医药科技有限公司宣布，一种用于治疗携带 KRAS G12D突变的晚期实体瘤患者的口服、高活性、高选择性小分子KRAS G12D抑制剂ABSK141的新 药临床试验(IND)申请已获得美国食品药品监督管理局(FDA)批准。 ...

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 ...

Group 1 - Company GFH375 has shown promising results in treating KRAS G12D mutation pancreatic ductal adenocarcinoma (PDAC) patients, with a 40.7% objective response rate and a 96.7% disease control rate in a study presented at the ESMO annual meeting [1] - The median progression-free survival was reported at 5.52 months, with a 92.2% overall survival rate at 4 months for patients treated with GFH375 [1] - The KRAS G12D mutation is prevalent, affecting nearly 30% of KRAS mutations, indicating a significant unmet clinical need in the patient population [2] Group 2 - GFH375 has received FDA fast track designation and is approved for I/II clinical trials, targeting both first-line and subsequent treatments for locally advanced and metastatic KRAS G12D mutation PDAC patients [2] - The drug is a highly selective small molecule KRAS G12D inhibitor that disrupts the activation of downstream pathways, effectively inhibiting tumor cell proliferation [2] - A collaboration agreement has been established between the company and Verastem for the development of three RAS/MAPK-driven cancer products, with GFH375 being the lead project [3]

Core Insights - GFH375 has shown promising efficacy and safety in treating KRAS G12D mutation pancreatic ductal adenocarcinoma (PDAC) patients, with a reported objective response rate of 40.7% and a disease control rate of 96.7% [1][2] - The KRAS G12D mutation is prevalent, affecting nearly 30% of KRAS mutations, indicating a significant unmet clinical need in the patient population [2] - The collaboration between the company and Verastem for the development of GFH375 marks a strategic partnership aimed at expanding the drug's market reach outside of China [3] Group 1 - GFH375's clinical trial data presented at the ESMO 2025 conference highlighted its effectiveness in a cohort of 59 advanced PDAC patients, with a median progression-free survival of 5.52 months and a 4-month overall survival rate of 92.2% [1] - The drug has received FDA fast track designation and is set to enter I/II phase trials in June 2024, targeting both first-line and subsequent-line treatments for advanced KRAS G12D mutation PDAC patients [2] - The chief medical officer of the company emphasized the rapid clinical progress and the significant unmet needs of KRAS G12D mutation patients, indicating plans for further research in both subsequent and frontline treatments [2] Group 2 - GFH375 is an oral, highly selective small molecule KRAS G12D inhibitor that disrupts the activation of downstream pathways, effectively inhibiting tumor cell proliferation [2] - The partnership with Verastem grants exclusive rights to develop and commercialize GFH375 outside of Greater China, while the company retains rights within China [3] - The collaboration is contingent upon achieving predefined milestones in the I phase clinical trials, with GFH375 being the lead project for Verastem [3]

Group 1: Core Insights - The recent approval of Jinfang Pharmaceutical's IPO marks a significant milestone for the Hong Kong innovative drug market, indicating an expansion of the 18A gate for new listings [1] - Jinfang Pharmaceutical focuses on KRAS mutations, particularly the KRAS G12C inhibitor, Fulzerasib, which is gaining attention in the market [1][5] - The global KRAS G12C inhibitor market is projected to grow from $489 million in 2024 to $3.491 billion by 2033, with a compound annual growth rate (CAGR) of 24.4% [3] Group 2: KRAS Market Dynamics - KRAS mutations account for approximately 14% of all cancer cases, with pancreatic cancer (88%), colorectal adenocarcinoma (50%), and lung adenocarcinoma (32%) being the most affected types [1] - The first KRAS G12C inhibitor, Sotorasib, had disappointing sales of $350 million in 2024, indicating challenges in market penetration [2][3] - Mirati Therapeutics' Adagrasib, another KRAS G12C inhibitor, is also underperforming with projected sales of $118 million in 2024 [3] Group 3: Fulzerasib's Potential - Fulzerasib has shown promising results in clinical trials for non-small cell lung cancer (NSCLC), achieving a confirmed overall response rate (cORR) of 49.1% [5][11] - The drug is positioned as a strong competitor in the KRAS G12C inhibitor market, potentially surpassing the first-in-class Sotorasib [11] - Fulzerasib is also expanding its indications to colorectal cancer, where it has demonstrated a cORR of 44.6% in early trials [9][11] Group 4: Business Development and Financials - Jinfang Pharmaceutical has secured significant partnerships, including a global exclusive licensing agreement with Innovent Biologics for Fulzerasib, which included upfront payments totaling $8.5 million [12] - The company has also engaged in collaborations for other pipelines, such as the KRAS G12D inhibitor GFH375, which has shown promising early clinical data [13][14] - Despite the potential of its lead product, the overall market for KRAS inhibitors remains underwhelming, necessitating further development and market strategies [11][15]