Core Viewpoint - Jinfang Pharmaceutical Technology (Shanghai) Co., Ltd. has submitted its IPO application to the Hong Kong Stock Exchange, aiming for a listing under the 18A rules, with CITIC Securities as the sole sponsor. This marks the second submission after the previous application lapsed [1][2]. Company Overview - Founded in 2017, Jinfang Pharmaceutical focuses on the development of innovative drugs for oncology, autoimmune, and inflammatory diseases. The company's core product, GFH925, a small molecule selective KRAS G12C protein inhibitor, received approval for marketing in August 2024 [1][3]. Market Competition - The KRAS G12C inhibitor market is becoming increasingly competitive, with several competitors already launched and others in late-stage clinical trials. The commercial prospects for GFH925 are uncertain due to the poor sales performance of existing competitors [2][5][6]. Product Development and Approval - GFH925 is the first KRAS G12C inhibitor approved in China for the second-line treatment of advanced non-small cell lung cancer (NSCLC). However, the product's commercial value remains to be validated [3][6]. Financial Performance - Jinfang Pharmaceutical has reported revenues of 105 million yuan, 73.73 million yuan, 105 million yuan, and 82.14 million yuan for the years 2022, 2023, and the first four months of 2025, respectively. The company has incurred total losses exceeding 1.5 billion yuan over three and a half years [9][10][11]. Patent Risks - GFH925 faces potential patent risks, with only one of five patent families granted authorization. The company has entered agreements to mitigate these risks, but the deletion of risk warnings from the updated prospectus raises concerns [7][8]. Collaborations and Agreements - The collaboration with Innovent Biologics regarding GFH925 has changed, requiring Jinfang Pharmaceutical to pay a termination fee of 20 million USD due to the alteration of rights concerning the product's commercialization [10][11].

Core Insights - The first KRAS G12C inhibitor developed by a Chinese company, Fulzerasib, has been approved for marketing in Macau, providing a new targeted therapy for patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutations [1][2] Group 1: Product Approval and Clinical Data - Fulzerasib specifically inhibits the oncogenic KRAS G12C protein, blocking tumor cell proliferation signals and addressing the limitations of traditional treatment methods [1] - In a Phase II clinical trial for Chinese patients with KRAS G12C-mutated advanced NSCLC, Fulzerasib demonstrated an objective response rate (ORR) of 49.1%, a median progression-free survival (PFS) of 9.7 months, a 12-month overall survival (OS) rate exceeding 54.4%, and a 12-month duration of response (DoR) rate of 53.7% [1] Group 2: Safety and Recommendations - The treatment-related adverse events were primarily grade 1-2, including anemia and various examination-related adverse reactions, which were effectively managed through dose adjustments and supportive care, with no unexpected severe toxic reactions observed [2] - Fulzerasib has received a level 1 recommendation for the treatment of KRAS G12C mutations in the recently published 2025 CSCO guidelines for non-small cell lung cancer, offering a new option that combines precision targeting, durable efficacy, and good tolerability for patients [2] Group 3: Market Expansion and Future Prospects - The approval of Fulzerasib in Macau marks a significant breakthrough for the company's innovative drugs in the Greater China region [2] - The company has multiple innovative products, including Daberu® and Dazhuo® that have been approved in various regions such as Indonesia, Hong Kong, Macau, and Taiwan, with additional products under registration in Brazil, Mexico, Colombia, and India, potentially bringing more innovative therapies to patients in Latin America and Southeast Asia [2]

Core Viewpoint - The article discusses the approval of the KRAS G12C inhibitor, Goratirsen (brand name "Airikai"), by the National Medical Products Administration for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation who have received at least one systemic therapy [2][3]. Group 1: Product Approval and Financial Implications - The approval of Goratirsen triggers a milestone payment of 50 million yuan to the developer, Gako Pharmaceutical, from its partner, Ailis [3]. - Lung cancer is the most prevalent and deadly malignancy globally, with non-small cell lung cancer accounting for approximately 85% of all lung cancer cases [3]. Group 2: Clinical Study Results - The approval is based on a pivotal Phase II single-arm study assessing the safety, tolerability, and efficacy of Goratirsen in patients with advanced NSCLC who have failed or are intolerant to standard treatments [3][4]. - The study included 119 NSCLC patients, with an independent review showing a confirmed objective response rate (cORR) of 49.6% (range: 40.2%-59.0%) and a disease control rate (DCR) of 86.3% (range: 78.7%-92.0%) [4]. - The median duration of response (DOR) was 14.5 months (range: 9.6-NE), median progression-free survival (PFS) was 8.2 months (range: 5.2-11.1), and median overall survival (OS) was 17.5 months (range: 13.6-NE) [4]. Group 3: Product Features and Future Developments - Goratirsen is the only KRAS G12C inhibitor approved in China that allows for once-daily oral administration, enhancing patient convenience [4]. - Ailis plans to commercialize Goratirsen and is conducting clinical studies for its use in combination with SHP2 inhibitors for first-line treatment of NSCLC, as well as for monotherapy in multiple tumor types [4].

Group 1 - The company's KRAS G12C inhibitor, citric acid gorasetinib (brand name "Airikai"), has received approval from the National Medical Products Administration for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutations who have received at least one systemic therapy [1] - As of September 28, 2024, a total of 119 NSCLC patients were included in the analysis [1] - The confirmed objective response rate (cORR) assessed by the Independent Radiologic Review Committee (IRC) reached 49.6% (40.2%-59.0%) [1] - The disease control rate (DCR) was 86.3% (78.7%-92.0%) [1] - The median duration of response (DOR) was 14.5 months (9.6-NE) [1] - The median progression-free survival (PFS) was 8.2 months (5.2-11.1) [1] - The median overall survival (OS) was 17.5 months (13.6-NE) [1]

Core Viewpoint - The National Medical Products Administration has conditionally approved the innovative drug Glecirasib (brand name: Airikai) developed by Elysium, which is indicated for adult patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations who have received at least one prior systemic therapy [1] Group 1 - The drug Glecirasib is classified as a first-class innovative drug [1] - The approval was granted through a priority review and approval process [1] - The target patient population includes adults with advanced NSCLC and specific genetic mutations [1]