Core Viewpoint - The stock price of 加科思-B (01167) has increased by 5.90% to 7 HKD, with a trading volume of 18.48 million HKD, following the approval of its self-developed KRAS G12C inhibitor, Goleirese, for commercialization in China through a partnership with艾力斯 [1] Company Summary - 加科思-B has entered into a licensing agreement with 艾力斯 for the commercialization of Goleirese in China, while multiple registration clinical trials are ongoing to maximize the clinical and market value of its assets [1] - The company focuses on innovative breakthroughs in difficult drug targets, maintaining controllable operating expenses while advancing its research projects, particularly in the KRAS field with a multi-dimensional layout including KRAS G12C, KRAS G12D, and Pan KRAS [1] - 加科思-B is developing a strong patent portfolio to ensure a first-mover advantage in the market while addressing issues of drug resistance and covering more subtypes of KRAS mutations [1] Industry Summary - The KRAS gene plays a crucial role in cell growth, differentiation, and proliferation, being a major gene for mutations in cancer [1] - The pan-KRAS inhibitor JAB-23E73 is expected to disclose Phase I climbing data in the first half of 2026, while the innovative targeted EGFR KRAS G12D tADC (JAB-BX600) is anticipated to submit an IND application in 2026, potentially creating further competitive barriers [1]

Core Viewpoint - The stock of 加科思-B (01167) has risen over 5%, currently trading at 6.98 HKD, with a transaction volume of 10.73 million HKD, following the approval of its self-developed KRAS G12C inhibitor, Golecitinib, for commercialization in China through a partnership with艾力斯 [1] Group 1: Company Developments - 加科思-B has entered into a licensing agreement with 艾力斯 for the commercialization of Golecitinib in China, while multiple registration clinical trials are ongoing to maximize the clinical and market value of its assets [1] - The company is focusing on innovative breakthroughs in difficult drug targets, maintaining controllable operating expenses while advancing its research and development projects, particularly in the KRAS field with a multi-dimensional layout including KRAS G12C, KRAS G12D, and Pan KRAS [1] - 加科思-B has established a strong patent portfolio to ensure a first-mover advantage in the market while focusing on innovation [1] Group 2: Industry Insights - The KRAS gene plays a crucial role in cell growth, differentiation, and proliferation, being a major gene for mutations in cancer [1] - In addition to the already marketed Golecitinib, 加科思-B is developing the pan-KRAS inhibitor JAB-23E73 and KRAS G12D to address different KRAS mutation subtypes and overcome resistance issues [1] - The pan-KRAS inhibitor JAB-23E73 is expected to disclose Phase 1 climbing data in the first half of 2026, while the innovative targeted EGFR KRAS G12D tADC (JAB-BX600) is anticipated to submit an IND application in 2026, potentially creating further competitive barriers through its patent portfolio [1]

Core Viewpoint - The company is focusing on its long-term strategic direction of oncology innovation by divesting non-oncology assets, which will optimize resource allocation and enhance organizational efficiency [1][3]. Group 1: Investment and Strategic Moves - The company announced a capital increase and equity transfer agreement where Haisheng Capital will acquire 80% of its subsidiary, Beijing Jakesi Ruikang Pharmaceutical, for RMB 200 million [1]. - After the transaction, the ownership structure will be 10% for Beijing Jakesi, 80% for Haisheng Capital, and 10% for an industry partner [1]. - The divestment aligns with the company's strategy to focus on its oncology pipeline, particularly in KRAS and iADC directions [1][3]. Group 2: Product Development and Clinical Trials - The company's KRAS G12C inhibitor, Glecirasib, has been approved for second-line treatment of KRAS G12C mutated non-small cell lung cancer (NSCLC) and has been successfully launched in China [2]. - The company has received a milestone payment of RMB 50 million from its partner, Elysium, following the successful commercialization of Glecirasib [2]. - The pan-KRAS inhibitor, JAB-23E73, has shown multiple confirmed partial response cases in ongoing Phase I clinical trials in China and the U.S., with complete data expected in the first half of 2026 [2]. Group 3: Market Position and Future Outlook - The company's pipeline value and long-term growth potential are not fully reflected in its current stock price, with a market cap of less than HKD 7 billion compared to Revolution Medicine's approximately USD 9 billion [3]. - The chairman and associated parties have significantly increased their holdings, signaling strong confidence in the company's long-term development [3]. - The company is expected to achieve market revaluation driven by clinical data validation and the gradual release of pipeline value [3].

Core Viewpoint - The company has received approval from CDE for clinical research on its PD-L1 small molecule inhibitor ABSK043 in combination with KRAS G12C inhibitor for treating KRAS G12C mutated NSCLC, indicating significant potential in the market for this combination therapy [1] Group 1: ABSK043 Development - ABSK043 is an oral PD-L1 inhibitor designed for combination therapy, showing a balance of efficacy and safety in preliminary clinical data [1][3] - The drug targets nearly half of the NSCLC market and has first-in-class (FIC) potential, with no other PD-(L)1 small molecule drugs currently available globally [1][3] - In a Phase I clinical trial involving 77 patients, 87.0% experienced treatment-emergent adverse events (TEAEs), with 29.9% being grade 3 or higher, and no peripheral neuropathy reported [1] Group 2: Clinical Efficacy - In a study of 10 lung cancer patients who had not received prior immune checkpoint inhibitor (ICI) treatment, the overall response rate (ORR) was 40%, with 50% of both EGFR and KRAS mutation patients achieving partial response (PR) [2] - Among EGFR mutation patients, those with PD-L1 TPS ≥50% showed progression after at least one line of EGFR TKI treatment [2] Group 3: Market Potential and Future Trials - ABSK043 has significant market potential in KRAS and EGFR NSCLC, which account for approximately 45%-60% of NSCLC cases, covering various treatment scenarios [3] - The company is also conducting a Phase II clinical trial combining ABSK043 with the third-generation EGFR TKI, furmonertinib, with preliminary safety data expected by Q4 2025 [3] - Beyond NSCLC, ABSK043 is involved in Phase I trials for monotherapy in solid tumors and in combination with FGFR2/3 inhibitors in China [3] Group 4: Other Key Assets and Financial Projections - The company is advancing multiple core assets, including the KRAS-G12D inhibitor ABSK141, which is expected to receive IND approval in H2 2025 [4] - The Pan-KRAS inhibitor ABSK211 is anticipated to enter clinical stages by 2026, while the CSF-1R inhibitor ABSK021 is expected to submit an NDA to the FDA in H2 2025 [4] - Financial projections estimate revenues of 630 million, 685 million, and 637 million yuan for 2025-2027, with net profits of 45 million, 70 million, and 102 million yuan respectively [4]

Investment Rating - The report maintains a "Buy" rating for the company [5] Core Insights - The company’s PD-L1 small molecule inhibitor ABSK043 has received approval for clinical research to treat KRAS G12C mutated NSCLC in combination with the KRAS G12C inhibitor, adagrasib [1] - ABSK043 shows potential as a first-in-class (FIC) oral PD-L1 inhibitor, with no other oral PD-(L)1 drugs currently available globally [2] - The initial clinical data indicates a balance of efficacy and safety, with 87% of patients experiencing treatment-emergent adverse events (TEAEs) and no peripheral neuropathy observed [2] - ABSK043 is designed specifically for combination therapy, offering advantages such as a short half-life, reduced immunogenicity, and oral administration flexibility [3] - The market potential for ABSK043 is significant, targeting approximately 45%-60% of NSCLC cases, with ongoing clinical trials in various treatment settings [3] Financial Projections - The company is projected to achieve revenues of 630 million, 685 million, and 637 million yuan for the years 2025, 2026, and 2027 respectively [5] - Expected net profits for the same period are 45 million, 70 million, and 102 million yuan [5] - The target price for the stock is set at 22.88 HKD, with the current price at 19.62 HKD [5] Pipeline Developments - The company has several key assets nearing milestones, including: 1. KRAS-G12D inhibitor ABSK141, expected to receive IND approval in the second half of 2025 [4] 2. Pan-KRAS inhibitor ABSK211, anticipated to enter clinical stages in 2026 [4] 3. CSF-1R inhibitor ABSK021, with an NDA submission planned for the second half of 2025 [4] 4. A bispecific antibody-drug conjugate (BsADC) targeting two pan-cancer targets, expected to achieve preclinical candidate status in early 2026 [4]

Core Viewpoint - The successful IPO of Jinfang Pharmaceutical on the Hong Kong Stock Exchange marks a significant milestone in the innovative drug sector, with a first-day increase of nearly 110% and a market capitalization approaching 15 billion [1][2]. Group 1: Company Overview - Jinfang Pharmaceutical, founded in 2017 by returning scientist Lü Qiang, focuses on the research and development of oncology and autoimmune drugs [1][2]. - The company has completed seven rounds of financing totaling 1.421 billion, with a post-investment valuation of 3.124 billion after the C+ round [1]. - The company has a strong foundation of cornerstone investors, including RTW Fund and OrbiMed, with over half being professional pharmaceutical investment institutions [1][2]. Group 2: Product Pipeline and Market Position - Jinfang's core product, Fluzelezib, is set to be launched in August 2024, making it the first KRAS G12C inhibitor approved in China and the third globally [2][3]. - The KRAS target is still in its early stages, with the overall market not yet fully developed, but Jinfang is positioned to be among the first to market with its product [2][3]. - The company has established multiple business development (BD) collaborations, contributing significantly to its revenue stream [7][8]. Group 3: Financial Performance and Revenue Sources - Jinfang's revenue for 2023, 2024, and the first four months of 2025 were reported at 73.73 million, 105 million, and 82.15 million respectively, with corresponding losses of 508 million, 678 million, and 6.6 million [8]. - The company has relied on BD transactions for income, which has become a core revenue source, although this dependence poses potential risks [8][9]. - The termination of the overseas rights for Fluzelezib with Innovent Biologics raised concerns about the future market prospects of this core product [9].

Core Viewpoint - The article discusses the successful IPO of Jinfang Pharmaceutical, which is the first domestic KRAS G12C inhibitor approved in China, highlighting its strong market performance and potential in the innovative drug sector [4][5][7]. Group 1: Company Overview - Jinfang Pharmaceutical was listed on the Hong Kong Stock Exchange on September 19, with a first-day increase of nearly 110%, reaching a market capitalization close to 15 billion [4]. - The company completed seven rounds of financing before its IPO, totaling 1.421 billion, with a post-investment valuation of 3.124 billion after the C+ round [5]. - Founded in 2017 by returning scientist Lü Qiang, Jinfang focuses on cancer drug development and has a strong background in the innovative drug ecosystem [5]. Group 2: Product Development - The core product, Fluorazirase, is the first KRAS G12C inhibitor approved in China and the third globally, with a market that is still in its early stages [7][10]. - The KRAS gene mutation is significant in cancer development, with approximately 14% of the 18 million new cancer cases annually carrying KRAS mutations [7]. - Jinfang's product pipeline includes another KRAS G12D inhibitor, GFH375, which is expected to enter Phase III clinical trials [11]. Group 3: Market Dynamics - The KRAS target is still considered to be in the early stages of market development, with existing approved products primarily for second-line treatment [8][10]. - Current sales figures for competing products like Sotorasib and Adagrasib are relatively low, indicating that the market has not yet fully opened [10]. - Jinfang's revenue from licensing agreements has become a significant income source, with various collaborations contributing to its financial stability [14][16]. Group 4: Financial Performance - Jinfang's revenues for 2023, 2024, and the first four months of 2025 are reported as 73.73 million, 105 million, and 82.15 million respectively, with corresponding losses primarily due to R&D investments [17]. - The company anticipates a reduction in net losses by 2025, attributed to income from intellectual property licensing [17]. - However, reliance on BD transactions for revenue poses risks, as market conditions and product valuations can change [18].

Group 1: Company Overview - Company name:劲方医药-B, established in 2017, focuses on innovative drug development for oncology, autoimmune, and inflammatory diseases [8][10] - The company has a product pipeline consisting of 8 candidate products, with 5 in clinical development, including core products GFH925 and GFH375 [10][12] - GFH925 is the first KRAS G12C inhibitor approved for commercialization in China, while GFH375 is a KRAS G12D inhibitor currently in clinical trials [12][16] Group 2: IPO Details - The IPO is scheduled from September 11 to September 16, with a listing date on September 19, at a price of HKD 20.39 per share [3][4] - The total fundraising amount is HKD 15.82 billion, with a total issuance of 77,600,000 shares, of which 10% is for public offering and 90% for international placement [3][4] - The company has a strong cornerstone investor base, with 9 investors committing USD 100 million, accounting for 49.27% of the total issuance [5] Group 3: Financial Performance - Revenue for 2023, 2024, and the first four months of 2025 is projected at RMB 73.74 million, RMB 104.70 million, and RMB 82.15 million respectively [18][22] - The company has been operating at a loss, with net profits of -RMB 508.32 million, -RMB 677.64 million, and -RMB 66.62 million for the respective periods [19][22] - As of April 30, 2025, the company has cash reserves of RMB 391 million [21] Group 4: Market and Competitive Landscape - The global KRAS G12C inhibitor market is expected to grow from USD 489 million in 2024 to USD 3.491 billion by 2033, with a compound annual growth rate of 24.4% [13][16] - The competitive landscape includes several approved KRAS G12C inhibitors, with GFH925 being the first in China and competing against products from major pharmaceutical companies [16] - The company aims to expand its product pipeline beyond RAS drugs, including candidates like GFS202A, a bispecific antibody targeting GDF15 and IL-6 [16][17]

Core Viewpoint - 加科思药业 has seen significant management confidence through recent share buybacks and purchases, indicating a belief in the undervaluation of the company and its pipeline potential [1][4] Group 1: Shareholder Actions - 加科思药业 announced that its concerted parties have recently increased their holdings by 854,400 shares at an average price of HKD 5.88 per share, totaling over HKD 5 million [1] - The company does not rule out the possibility of further share purchases in the future [1] - The management's high-level purchases reflect a strong belief in the company's value and pipeline confidence, especially after a 427% increase in stock price year-to-date [1] Group 2: Product Pipeline and Market Potential - The company's most notable product, the KRAS inhibitor JAB-23E73, has entered Phase I trials in China and the U.S., with a global sales peak potential of USD 12.1 billion, particularly in pancreatic and non-small cell lung cancers [2] - JAB-23E73 is a small molecule oral drug with promising pharmacokinetics and significant anti-tumor activity, showing a cost advantage over competitors [3] - 加科思's market capitalization is currently at HKD 5 billion, significantly lower than Revolution Medicine's USD 7 billion, indicating substantial upside potential [3] Group 3: Financial Outlook and Revenue Generation - The approval of the KRAS G12C inhibitor, 戈来雷塞, marks a critical milestone for 加科思, expected to generate stable cash flow through its commercialization [4] - 戈来雷塞 is priced at approximately HKD 38,000 per month, with a potential market size of HKD 6 billion based on patient demographics and market share estimates [4] - The strategic partnership with 艾力斯 for sales in China could yield approximately HKD 200 million annually from milestone and sales sharing, providing solid performance support for the company's current valuation [5] Group 4: Future Developments - The SHP2 inhibitor JAB-3312 is the first of its kind to enter Phase III trials, with potential implications for first-line treatment of non-small cell lung cancer, which could trigger additional milestones for 艾力斯 and become a new revenue source [6]

聚焦肿瘤、自体免疫和炎症性疾病领域。 本文为IPO早知道原创 作者｜罗宾 2021年，劲方医药与信达生物（1801.HK）就GFH925达成授权交易，授予信达生物于大中华区开 发及商业化GFH925权益，以及在中国以外的全球地区开发及商业化此款产品的中国境外选择权。 2024年1月，双方签订GFH925补充协议，终止上述协议中的中国境外选择权。 劲方正在推进GFH925的海外临床开发，包括在EMA监管区域内国家进行与cetuximab（一款靶向 EGFR的抗体药物）联用作为一线治疗晚期NSCLC的联合疗法的Ib/II期临床试验。公司认为此款联 合疗法有望在抑制EGFR-RAS通路方面实现协同效应。 劲方医药另一款核心产品GFH312为劲方医药自主研发的高效小分子抑制剂，能针对受体相互作用的 丝氨酸/苏氨酸蛋白激酶1（RIPK1）并抑制其激酶活性， GFH312已获得FDA关于在美国开展第II 期临床试验的IND批准 ，以评估GFH312对外周动脉疾病（PAD）伴间歇性跛行（IC）患者的安全 性和疗效。与全球其他临床阶段的RIPK1抑制剂相比，劲方医药聚焦 GFH312的差异化临床计划， 针对一些可能严重影响患 ...