劲方医药-B(02595) - 2025 - 中期财报

Company Information This section provides basic company information for GenFleet Therapeutics (Shanghai) Co., Ltd., including board members, committee compositions, registered office, principal place of business, legal counsel, principal bankers, auditor, stock code, and company website - The Board of Directors comprises executive directors (Dr. Lu Qiang, Dr. Lan Jiong, Ms. Zhang Wei), non-executive directors (Mr. Zhu Jingyang, Ms. Tao Sha), and independent non-executive directors (Ms. Lu Shaohua, Dr. Zhou Demin, Mr. Li Bo)[5] - Ms. Lu Shaohua chairs the Audit Committee, Mr. Li Bo chairs the Remuneration Committee, and Dr. Lu Qiang chairs the Nomination Committee[5] - The company's registered office, headquarters, and principal place of business in China are located at 1206 Zhangjiang Road, China (Shanghai) Pilot Free Trade Zone[5] - The company's auditor is Ernst & Young, its stock code is 2595, and its website is genfleet.com[6] Management Discussion and Analysis This section comprehensively reviews GenFleet Therapeutics' business development, product pipeline progress, R&D capabilities, strategic planning, industry overview, and financial performance, highlighting its commitment to innovative therapies for oncology, autoimmune, and inflammatory diseases, significant progress in RAS-targeted therapies, and active expansion of global collaborations and internal manufacturing capabilities Business Review The company is an innovative drug development company based in China, focusing on oncology, autoimmune, and inflammatory diseases, having built a diversified pipeline of eight candidate products through an integrated R&D system, with seven in clinical development, and holding a leading position in RAS-targeted therapies Our Products and Pipeline The company has established a continuously updated pipeline of eight candidate products, with seven in clinical development, focusing on RAS family therapies, and holds 71 granted patents and 112 pending patent applications - As of the Latest Practicable Date, the company has eight candidate products, with seven in clinical development[9] - Core product GFH925 (Dabert®) has been approved for commercialization in China for the treatment of advanced non-small cell lung cancer (NSCLC)[9] - Another core product, GFH375, is one of the most advanced oral bioavailable KRAS G12D inhibitors globally[9] Overview of Candidate Drug Development Status (As of the Latest Practicable Date) | Compound | Target | Administration | Indication (Clinical Stage) | Key Regulatory Authority | Commercial Rights | | :--- | :--- | :--- | :--- | :--- | :--- | | Oncology: RAS-focused | | | | | | | GFH925 | KRAS G12C | Oral | Advanced NSCLC (Phase III planned) | FDA, EMA | Global (ex-Greater China) | | GFH375 | KRAS G12D | Oral | Advanced PDAC, NSCLC, and CRC (Phase I/II) | NMPA | Greater China | | GFH276 | Pan-Ras | Oral | Advanced Solid Tumors (IND approved) | / | Global | | GFS784 | ADC (Novel Payload) | Injection | Advanced Solid Tumors (Preclinical) | / | Global | | Oncology: Others | | | | | | | GFS202A | GDF15/IL-6 | Injection | Cachexia (Phase I) | NMPA | Global | | GFH009 | CDK9 | Injection | Advanced AML (Clinical Stage) | NMPA | Ex-Greater China | | GFH018 | TGF-βR1 | Oral | Various Advanced Solid Tumors (Clinical Stage) | NMPA, TFDA, TGA | Global | | Immunology | | | | | | | GFH312 | RIPK1 | Oral | PBC (Phase II planned), PAD with IC (Phase II) | NMPA, TGA, FDA | Global | Our Core RAS-Targeted Products This section details the development progress of the company's two core RAS-targeted products, GFH925 and GFH375, with GFH925 approved for marketing in China and showing significant efficacy in overseas combination therapies, while GFH375, a globally leading KRAS G12D inhibitor, demonstrates potential in preclinical and preliminary clinical studies, with multiple clinical trials initiated GFH925 – A KRAS G12C Small Molecule Selective Inhibitor for NSCLC and CRC GFH925 (Dabert®) is China's first and the world's third approved KRAS G12C selective inhibitor, approved by the NMPA for second-line or later-line treatment of advanced NSCLC, and showing an 80% overall response rate and 100% disease control rate in a European Ib/II clinical trial with cetuximab combination therapy, with Phase III trials planned in the US and Europe - GFH925 is the first KRAS G12C selective inhibitor approved in China and the third globally[13] - Received NMPA NDA approval in China in August 2024 for second-line or later-line treatment of advanced NSCLC[13] - GFH925 monotherapy received two Breakthrough Therapy Designations (BTD) from the NMPA in January and May 2023, respectively, for the treatment of patients with advanced KRAS G12C-mutated NSCLC and CRC[14] - In a European Ib/II clinical trial, GFH925/cetuximab combination therapy achieved an overall response rate (ORR) of 80% and a disease control rate (DCR) of 100%, with an ORR of 71.4% in patients with brain metastases[16] - Phase II clinical trials are planned for completion by Q4 2025, with applications for Phase III clinical trials in the US and Europe based on European clinical results[17] - The FDA approved the IND application for GFH925 monotherapy in April 2024 for a Phase III clinical trial in refractory metastatic CRC in later-line treatment[17] GFH375: An Oral Bioavailable Small Molecule KRAS G12D Inhibitor GFH375 is a company-discovered oral, bioavailable, potent, and highly selective small molecule KRAS G12D inhibitor, capable of targeting both "active" and "inactive" states of KRAS G12D, which, as a globally leading drug, has initiated Phase I/II clinical trials in China and entered an exclusive licensing collaboration with Verastem for regions outside Greater China, with commercial-scale production expected by the end of 2028 - GFH375 is one of the most advanced oral bioavailable KRAS G12D inhibitors globally, capable of simultaneously targeting both "active" and "inactive" states of the KRAS G12D protein[18][19] - KRAS G12D is a common oncogenic KRAS mutation prevalent in pancreatic cancer, CRC, and NSCLC, with no approved treatment options currently available[18] - Phase I/II clinical trials for GFH375 have been initiated in China, with IND approval from the NMPA in June 2024 and the Phase II portion commencing in February 2025[20] - In January 2025, Verastem exercised an option to obtain an exclusive license to develop and commercialize GFH375 outside Greater China[12][105] - Trial operation of internal manufacturing facilities is expected to commence by the end of 2026, with commercial-scale production of GFH375 starting by the end of 2028[20] Our Diversified Innovative RAS-Targeted Candidates to Harness the Therapeutic Potential of the RAS Pathway Leveraging experience from GFH925 and GFH375 development, the company is expanding its RAS-targeted product matrix to cover common mutant RAS proteins and inhibit RAS protein overactivation through pan-RAS approaches, including molecular glue GFH276 and novel drug modality GFS784 GFH276 – A Pan-RAS (Active) Molecular Glue GFH276 is the company's flagship candidate exploring a pan-RAS approach, acting as a molecular glue by forming a binary complex with chaperone protein Cyclophilin A (CypA) to interact with "active" RAS, blocking downstream signaling pathways, which showed potential antiproliferative activity in preclinical studies and received NMPA IND approval for Phase I/II clinical trials in September 2025 - GFH276 is a pan-RAS (active) molecular glue that forms a binary complex with CypA, interacting with active RAS to disrupt tumor cell growth signaling pathways[22] - Preclinical studies showed GFH276 has potential antiproliferative activity in tumor cell lines carrying various RAS family member mutations, with activity unaffected by upstream RTK activation[22] - The IND application for GFH276 Phase I/II clinical trials was submitted to the NMPA in June 2025 and received IND approval in September 2025[23] GFS784 – A Novel Drug Modality Utilizing Synergistic Effects of Small and Large Molecules GFS784 is the company's leading FAScon (Functional Antibody Synergistic Conjugate) candidate, comprising an EGFR-blocking antibody and a small molecule pan-RAS inhibitor, which is expected to offer broader coverage, be less susceptible to drug resistance, and has shown durable antitumor activity in preclinical studies - GFS784 is a novel FAScon candidate, combining an EGFR-blocking antibody and a small molecule pan-RAS inhibitor[24] - This drug modality aims to address RAS with broader coverage and reduced susceptibility to drug resistance[24] - Preclinical studies demonstrated durable antitumor activity of GFS784 in mouse models[24] Differentiated Clinical Programs and Market Potential Beyond Our RAS Matrix Beyond the RAS family, the company is committed to developing a diversified pipeline, including the self-developed RIPK1 kinase inhibitor GFH312 for autoimmune and inflammatory diseases, and the GDF15 and IL-6 bispecific antibody GFS202A as a potential therapy for cachexia GFH312 – A RIPK1 Small Molecule Inhibitor GFH312 is the first RIPK1 inhibitor developed by a Chinese company to enter clinical stages, with potential for treating peripheral artery disease with intermittent claudication (PAD with IC) and primary biliary cholangitis (PBC), having completed Phase I clinical trials in Australia and China, received FDA approval for Phase II clinical trials in PAD with IC, and NMPA approval for Phase II clinical trials in PBC - GFH312 is the first RIPK1 inhibitor candidate developed by a Chinese company to enter clinical stages[26] - Preclinical studies showed GFH312 has potent and selective inhibitory effects on RIPK1, anti-inflammatory effects, and can penetrate the blood-brain barrier[26] - Phase I clinical trials of GFH312 in healthy subjects have been completed in Australia and China[27] - The FDA has approved Phase II clinical trials for GFH312 in PAD with IC[27] - NMPA approval was obtained in May 2025 for Phase II clinical trials of GFH312 for PBC, planned to commence in H1 2026[27] GFS202A – A Novel Bispecific Antibody for Cachexia GFS202A is a novel bispecific antibody targeting GDF15 and IL-6, designed to treat cachexia, a common and life-threatening wasting disease with no currently approved dedicated drugs, having shown significant improvement in cachexia with weight loss in preclinical studies, and with Phase I clinical trials commenced in April 2025 - GFS202A is a novel bispecific antibody targeting GDF15 and IL-6 for the treatment of cachexia[28] - As of the Latest Practicable Date, there are no dedicated drugs approved by the FDA or NMPA for the treatment of cachexia[28] - Preclinical pharmacological models showed GFS202A significantly improved cachexia with weight loss and was well-tolerated[28] - NMPA IND approval was obtained in March 2025, and Phase I clinical trials for GFS202A monotherapy in cachexia commenced in April 2025[28] Integrated R&D Platform, Expertise, and Business Development Capabilities The company's diversified product pipeline is supported by its integrated R&D platform, covering target discovery, molecular discovery and evaluation, translational science, and clinical development, complemented by differentiated CMC expertise to accelerate drug development and control costs, while also maximizing pipeline value through diversified collaborations Strong R&D Capabilities Driven by an Integrated Technology Platform The company possesses a robust integrated R&D platform encompassing target discovery (utilizing computational biology, bioinformatics, and AI), molecular discovery and evaluation (integrated molecular design, synthesis, and optimization), and translational science and clinical development (biomarkers, precision medicine, data science), effectively advancing drug development - The integrated R&D platform covers target discovery, molecular discovery and evaluation, translational science, and clinical development, complemented by CMC expertise[30] - The target discovery platform utilizes computational biology, bioinformatics, and artificial intelligence to systematically track, discover, and evaluate new drug targets[32] - The molecular discovery and evaluation platform includes integrated molecular design, synthesis, and optimization technologies, as well as efficient drug metabolism and pharmacokinetic research technologies[32] - The translational science and clinical development platform covers biomarker clinical translation technology, precision medicine technology throughout the project lifecycle, and clinical development technology based on data science and quantitative analysis[32] Differentiated CMC Expertise to Accelerate Drug Development and Facilitate Cost Control The company has established reliable in-house CMC (Chemistry, Manufacturing, and Control) capabilities, covering key aspects from preclinical candidate synthesis to commercial supply, which significantly accelerated drug development (e.g., GFH925 from IND to marketing approval in approximately three years) and substantially reduced GFH925 production costs by about 30-fold through process optimization - The company has established comprehensive CMC capabilities, covering process development and quality control from preclinical candidate synthesis pathway design to clinical development and commercial drug supply[33] - CMC capabilities enabled GFH925 to obtain marketing approval in China approximately three years after IND approval, accelerating drug development[33] - By optimizing process routes and scaling up production, GFH925's production cost was significantly reduced by approximately 30-fold, facilitating cost control[33] - Will collaborate with Innovent Biologics to ensure commercial supply of GFH925 in China[33] Diversified Collaborations to Maximize the Value of Our Pipeline Programs The company actively seeks diversified global business development opportunities and strategic partnerships to maximize the commercial potential of its pipeline products and enhance development efficiency, having established collaborations with Innovent Biologics (GFH925), SELLAS (GFH009), Verastem (RAS-targeted products), and Merck (cetuximab supply), leveraging mutual strengths to advance pipeline development - Actively seeking diversified global business development opportunities, strategically selecting partners to complement strengths and create value[34] - Collaborating with Innovent Biologics to advance the development and commercialization of GFH925 in China[34] - Collaborating with SELLAS on GFH009 development and with Verastem on RAS-targeted pipeline products[34] - Obtained cetuximab supply from Merck for clinical trials of GFH925 in combination with cetuximab as a first-line treatment for advanced NSCLC[34] Strategies The company's strategy focuses on advancing core and leading candidate products through global clinical development, strengthening its RAS pathway product matrix, and executing a global strategy through extensive and diversified commercialization and pipeline development collaborations, while also planning to establish GMP-compliant formulation manufacturing facilities and continuously attract, retain, and motivate high-caliber talent Advancing Core and Leading Candidate Products Through Global Clinical Development The company plans to leverage its strong internal clinical and development capabilities to efficiently advance the global clinical development of core products like GFH925 and GFH375, and leading candidates such as GFH312, maximizing asset therapeutic value by expanding indications and combination regimens - Aims to efficiently advance core products (GFH925 and GFH375) and other leading candidate products (e.g., GFH312) through various clinical development programs[35] - Plans to maximize the therapeutic value of assets by expanding the number of indications and combination regimens for candidate products[35] Focusing on a Comprehensive RAS Pathway Product Matrix, Advancing and Supplementing Our Other Innovative Product Pipelines The company is committed to achieving significant development milestones for its RAS matrix pipeline products in the coming years to solidify its competitive advantage in RAS-targeted therapies, while simultaneously monitoring the market environment to explore more drug development opportunities in oncology, autoimmune, and inflammatory diseases to supplement its product pipeline - Committed to achieving significant development milestones for RAS matrix pipeline products in the coming years, solidifying its position and competitive advantage in RAS-targeted therapies[36] - Plans to advance other RAS matrix candidate products (currently in preclinical stages) into clinical stages[36] - Exploring more drug development opportunities with significant market potential, particularly in oncology, autoimmune, and inflammatory diseases[36] Executing Global Strategy Through Extensive and Diversified Commercialization Arrangements, Business Development, and Pipeline Development Collaborations The company plans to expand its geographical reach, accelerate global development of candidate products, and maximize pipeline value by establishing strategic partnerships with leading domestic and international pharmaceutical companies, with collaboration models covering early drug discovery, clinical development, manufacturing, and later-stage licensing arrangements - Continues to actively collaborate with existing and potential partners to explore potential opportunities for indication expansion and combination therapies[37] - Plans to establish strategic partnerships with leading domestic and international pharmaceutical companies to expand geographical coverage and accelerate global development[37] - Adopting a multi-layered development strategy, including early-stage collaborations leveraging partner experience and later-stage licensing arrangements with large multinational corporations[37] Establishing GMP-Compliant Formulation Manufacturing Facilities To support the clinical development and commercialization of its diversified product pipeline and leverage existing CMC capabilities to reduce operating costs, the company plans to construct GMP-compliant formulation manufacturing facilities to enhance internal production capacity and ensure products meet regulatory requirements - Plans to construct GMP-compliant formulation manufacturing facilities to leverage existing CMC capabilities, reduce operating costs, and cover the full lifecycle of clinical development[38] - The construction of this facility aims to enhance production capacity and ensure products meet regulatory clinical and market approval requirements[38] - As of the Latest Practicable Date, the company is carefully formulating its facility construction plan[38] Attracting, Retaining, and Motivating High-Caliber Talent Across Our Business Functions The company views employees as key to its growth strategy and will continue to invest in attracting, training, promoting, and retaining top global talent across all business functions, including discovery, R&D, manufacturing, and commercialization, by offering competitive compensation, continuous education, and a collaborative culture - Employees are key to the company's growth strategy and the development and commercialization of innovative drugs[39] - Will continue to recruit, train, promote, and retain relevant talent in the pharmaceutical and biotechnology industries, including in discovery, research and development, manufacturing, and commercialization[39] - Provides continuous education and training programs, along with competitive salaries, bonuses, and share-based payments to incentivize employees[39][64] Employee and Compensation Overview | Metric | Data | | :--- | :--- | | Total Employees as of the Latest Practicable Date | 94 (excluding two co-founders) | | Percentage of Employees in R&D Function | 78% (73 employees) | | Total Compensation Costs for H1 2025 | RMB 49.76 million | | Total Compensation Costs for H1 2024 | RMB 59.78 million | Industry Overview This section outlines the development of the global cancer treatment market, emphasizing the growing demand for differentiated therapies, especially effective treatments for KRAS mutations (e.g., G12C and G12D), with the company's core products, GFH925 and GFH375, representing significant advancements in treating KRAS-mutated cancers - Cancer is one of the leading causes of death globally, with a continuous increase in medical demand for differentiated therapies that can improve remission duration and overall survival for oncology patients[40] - KRAS mutations (especially G12C and G12D) are key oncogenic drivers in relevant cancers, with rapidly growing global demand for effective therapies targeting these mutations[40] - The company's core products, GFH925 (KRAS G12C inhibitor) and GFH375 (KRAS G12D inhibitor), represent significant advancements in treating KRAS-mutated cancers[41] Future and Outlook The company reaffirms its corporate mission "Addressing Unmet Clinical Needs, Creating Global New Drugs" and its vision "Driven by Technology, Building a Globally Competitive Biopharmaceutical Company," with future plans including accelerating core product clinical development, advancing innovative pipelines to later stages, expanding the product portfolio, promoting global strategies through diversified collaborations, establishing GMP-compliant facilities, and expanding its professional team to become a globally competitive biopharmaceutical company - Corporate Mission: "Addressing Unmet Clinical Needs, Creating Global New Drugs"; Corporate Vision: "Driven by Technology, Building a Globally Competitive Biopharmaceutical Company"[42] - Aims to accelerate core product clinical development, rapidly advance innovative product pipelines to later stages, and expand the product portfolio in oncology, autoimmune, and inflammatory diseases[42] - Will advance global strategies through extensive and diversified collaborations, establish GMP-compliant facilities for internalized drug production, and expand its professional team[42] Financial Review For the six months ended June 30, 2025, the company recorded revenue of RMB 88.74 million for the first time, but net loss for the period expanded to RMB 698.60 million, primarily due to changes in the fair value of redeemable equity shares, with R&D costs decreasing and administrative expenses increasing due to listing-related fees, resulting in negative operating cash flow, increased net current liabilities, and a rising gearing ratio Revenue For the six months ended June 30, 2025, the company recorded revenue of RMB 88.74 million for the first time, primarily from intellectual property licensing, sales of goods, and R&D services, with no revenue recognized in the prior corresponding period Revenue Comparison | Metric | H1 2025 (RMB million) | H1 2024 (RMB million) | | :--- | :--- | :--- | | Revenue | 88.74 | – | Cost of Sales For the six months ended June 30, 2025, the company recorded a cost of sales of RMB 16.92 million, primarily attributable to fulfilling drug supply arrangements, with no cost of sales in the prior corresponding period Cost of Sales Comparison | Metric | H1 2025 (RMB million) | H1 2024 (RMB million) | | :--- | :--- | :--- | | Cost of Sales | 16.92 | – | - Cost of sales was primarily attributable to fulfilling drug supply arrangements[44] Other Income and Gains For the six months ended June 30, 2025, other income and gains amounted to RMB 8.18 million, a decrease of approximately 27.41% from RMB 11.27 million in the prior corresponding period, mainly due to reduced foreign exchange, fair value gains on financial assets, and lease revaluation Other Income and Gains Comparison | Metric | H1 2025 (RMB million) | H1 2024 (RMB million) | | :--- | :--- | :--- | | Other Income and Gains | 8.18 | 11.27 | | YoY Change | -27.41% | - | - The decrease was primarily attributable to reduced foreign exchange, fair value gains on financial assets at fair value through profit or loss, and lease revaluation[45] Research and Development Costs For the six months ended June 30, 2025, R&D costs decreased to RMB 122.44 million from RMB 186.00 million in the prior corresponding period, mainly because expenses incurred from the termination of overseas option and patent license agreements in the prior period did not recur in the current period R&D Costs Comparison | Metric | H1 2025 (RMB million) | H1 2024 (RMB million) | | :--- | :--- | :--- | | R&D Costs | 122.44 | 186.00 | | YoY Change | -34.17% | - | - The decrease was primarily due to expenses (totaling RMB 64.27 million) incurred from the termination of overseas option and patent license agreements in H1 2024 not recurring in the current period[46][48] R&D Expense Details (RMB thousand) | R&D Expense Details | H1 2025 | H1 2024 | | :--- | :--- | :--- | | CMC, Materials, and Preclinical Costs | 41,114 | 28,110 | | Clinical Development Costs | 34,579 | 34,220 | | Staff Costs | 28,123 | 33,762 | | Share-based Payments | 9,982 | 14,519 | | Depreciation and Amortization | 4,538 | 6,351 | | Intellectual Property Management Expenses | 1,666 | 2,793 | | Termination Fees | – | 45,403 | | Patent License Agreements | – | 18,868 | | Others | 2,433 | 1,975 | | Total | 122,435 | 186,001 | Administrative Expenses For the six months ended June 30, 2025, administrative expenses were RMB 36.95 million, an increase of approximately 99.64% from RMB 18.51 million in the prior corresponding period, mainly due to increased listing-related fees incurred during the reporting period Administrative Expenses Comparison | Metric | H1 2025 (RMB million) | H1 2024 (RMB million) | | :--- | :--- | :--- | | Administrative Expenses | 36.95 | 18.51 | | YoY Change | +99.64% | - | - The increase was primarily due to increased listing-related fees incurred during the reporting period[49] Other Expenses For the six months ended June 30, 2025, other expenses increased from RMB 3 thousand in the prior corresponding period to RMB 292 thousand, primarily attributable to exchange differences Other Expenses Comparison | Metric | H1 2025 (RMB thousand) | H1 2024 (RMB thousand) | | :--- | :--- | :--- | | Other Expenses | 292 | 3 | | YoY Change | +9633% | - | - The increase was primarily attributable to exchange differences[50] Finance Costs For the six months ended June 30, 2025, finance costs decreased from RMB 14.60 million in the prior corresponding period to RMB 3.03 million, primarily due to reduced transaction costs for issuing redeemable equity shares Finance Costs Comparison | Metric | H1 2025 (RMB million) | H1 2024 (RMB million) | | :--- | :--- | :--- | | Finance Costs | 3.03 | 14.60 | | YoY Change | -79.25% | - | - The decrease was primarily due to reduced transaction costs for issuing redeemable equity shares[51] Fair Value Changes of Redeemable Equity Shares For the six months ended June 30, 2025, the fair value change of redeemable equity shares was a negative RMB 615.87 million, a significant expansion of loss compared to a negative RMB 241.46 million in the prior corresponding period, primarily attributable to changes in the company's valuation Fair Value Changes of Redeemable Equity Shares Comparison | Metric | H1 2025 (RMB million) | H1 2024 (RMB million) | | :--- | :--- | :--- | | Fair Value Change | (615.87) | (241.46) | | YoY Change | Loss expanded 155% | - | - The change was primarily attributable to changes in the company's valuation[52] Loss for the Period For the six months ended June 30, 2025, the loss for the period was RMB 698.60 million, a significant increase from RMB 449.30 million in the prior corresponding period, primarily impacted by changes in the fair value of redeemable equity shares Loss for the Period Comparison | Metric | H1 2025 (RMB million) | H1 2024 (RMB million) | | :--- | :--- | :--- | | Loss for the Period | (698.60) | (449.30) | | YoY Change | Loss expanded 55.49% | - | Liquidity and Capital Resources For the six months ended June 30, 2025, the company recorded a negative cash flow from operating activities of RMB 50.49 million, primarily from R&D costs, with cash and cash equivalents at RMB 346.53 million, a decrease from the end of 2024, as the company primarily relies on equity financing and expects to generate more cash flow in the future through GFH925 commercialization and pipeline development Cash Flow from Operating Activities Comparison | Metric | H1 2025 (RMB million) | H1 2024 (RMB million) | | :--- | :--- | :--- | | Net Cash Flow Used in Operating Activities | (50.49) | (162.96) | Cash and Cash Equivalents Comparison | Metric | As of June 30, 2025 (RMB million) | As of December 31, 2024 (RMB million) | | :--- | :--- | :--- | | Cash and Cash Equivalents | 346.53 | 362.13 | - The Group relies on equity financing as its primary source of liquidity[54] - Expects to generate more cash flow in the future through GFH925's launch and commercialization revenue, collaboration agreements, and other pipeline product development[54] Foreign Exchange Risk The company primarily operates in China, settling most transactions in RMB, but its US and Australian subsidiaries have functional currencies of USD and AUD, respectively, thus facing foreign exchange risk, with no hedging contracts currently in place, but continuous monitoring and potential mitigation measures are considered - The Group primarily operates in China, with most transactions settled in RMB[55] - Faces foreign exchange risk, primarily from monetary assets, liabilities, and transactions denominated in USD and AUD[55] - Currently has no foreign exchange hedging contracts but will continue to monitor closely[55] Bank Borrowings As of June 30, 2025, the company's total outstanding bank borrowings were RMB 79.00 million, all unsecured and due within one year, with annual interest rates ranging from 2.30% to 2.75%, and the gearing ratio significantly increased to 578.62% due to the increase in redeemable equity shares Bank Borrowings Comparison | Metric | As of June 30, 2025 (RMB million) | As of December 31, 2024 (RMB million) | | :--- | :--- | :--- | | Total Outstanding Borrowings | 79.00 | 51.13 | | Nature of Borrowings | Unsecured | Unsecured | | Maturity Date | Within one year | Within one year | | Annual Interest Rate | 2.30%-2.75% | 2.50%-2.90% | Gearing Ratio Comparison | Metric | As of June 30, 2025 | As of December 31, 2024 | | :--- | :--- | :--- | | Gearing Ratio | 578.62% | 422.38% | | Reason for Change | Primarily due to increased redeemable equity shares | - | Pledged Assets As of June 30, 2025, the company had not pledged or mortgaged any assets - As of June 30, 2025, the Group had not pledged or mortgaged any assets[57] Contingent Liabilities As of June 30, 2025, the company had no significant contingent liabilities or guarantees - As of June 30, 2025, the Group had no significant contingent liabilities or guarantees[58] Significant Acquisitions and/or Disposals of Subsidiaries, Associates, and Joint Ventures For the six months ended June 30, 2025, the company had no significant acquisitions and/or disposals of subsidiaries, associates, and joint ventures - For the six months ended June 30, 2025, the Group had no significant acquisitions and/or disposals of subsidiaries, associates, and joint ventures[59] Material Investments As of the Latest Practicable Date, the company held no material investments representing 5% or more of the Group's total assets - As of the Latest Practicable Date, the Group held no material investments representing 5% or more of the Group's total assets[60] Future Plans for Material Investments and Capital Assets Except as disclosed in this report, as of the Latest Practicable Date, the company had no other material investment plans or capital asset plans - Except as disclosed in this report, as of the Latest Practicable Date, the Group had no other material investment plans or capital asset plans[61] Employees and Remuneration Policy As of the Latest Practicable Date, the company had a total of 94 employees (excluding two co-founders), with 78% engaged in R&D, and attracts, retains, and motivates high-caliber talent through competitive compensation, continuous education and training programs, and incentive schemes, with total compensation costs for the six months ended June 30, 2025, at RMB 49.76 million Number of Employees by Function (As of the Latest Practicable Date) | Function | Number of Employees | Percentage | | :--- | :--- | :--- | | R&D | 73 | 78% | | Business Strategy and Corporate Development | 3 | 3% | | General and Administrative | 18 | 19% | | Total | 94 | 100% | Compensation Costs Comparison | Metric | H1 2025 (RMB million) | H1 2024 (RMB million) | | :--- | :--- | :--- | | Total Compensation Costs | 49.76 | 59.78 | - The company provides continuous education and training programs, along with competitive salaries, bonuses, and share-based payments to incentivize employees[64] Corporate Governance and Other Information This section outlines the company's commitment to and practices in corporate governance, including compliance with the Corporate Governance Code and Model Code for Securities Transactions by Directors (applicable post-listing), the functions of the Audit Committee, planned use of global offering proceeds, and the execution of the pre-IPO share incentive scheme, also disclosing the significant event of H-share listing on the Stock Exchange on September 19, 2025 Compliance with Corporate Governance Code The company is committed to upholding the highest standards of corporate governance, and as H-shares were not listed during the reporting period (ended June 30, 2025), relevant provisions of the Corporate Governance Code were not applicable, but the company will regularly review and monitor its corporate governance practices post-listing - The company and its directors are committed to upholding and implementing the highest standards of corporate governance[65] - As H-shares were not listed on the Stock Exchange as of June 30, 2025, the code provisions set out in Part 2 of the Corporate Governance Code were not applicable during the reporting period[65] - The company will regularly review and monitor its corporate governance practices to ensure compliance with the Corporate Governance Code[66] Compliance with Model Code for Securities Transactions by Directors and Supervisors The company has adopted the Model Code as the code of conduct for directors and supervisors regarding securities transactions, which was not applicable during the reporting period as H-shares were not listed, but will become effective from the listing date - The company has adopted the Model Code as the code of conduct for directors and supervisors regarding transactions in the company's securities[67] - As H-shares were not listed on the Stock Exchange as of June 30, 2025, the Model Code was not applicable during the reporting period[67] - The provisions under the Listing Rules regarding compliance with the Model Code for securities transactions by directors and supervisors have been applicable to the company since the listing date[67] Purchase, Sale, or Redemption of the Company's Listed Securities As of June 30, 2025, since the shares were not yet listed on the Stock Exchange, neither the company nor any of its subsidiaries purchased, sold, or redeemed any of the company's listed securities, nor held any treasury shares - During the reporting period, neither the company nor any of its subsidiaries purchased, sold, or redeemed any of the company's listed securities[68] - As of June 30, 2025, the company held no treasury shares[68] Audit Committee The Audit Committee comprises Ms. Lu Shaohua (Chairperson), Mr. Zhu Jingyang, and Dr. Zhou Demin, with terms of reference compliant with the Listing Rules, and has reviewed the unaudited condensed consolidated financial statements for the six months ended June 30, 2025, and discussed accounting policies and internal control matters with senior management - The Audit Committee comprises Ms. Lu Shaohua (Chairperson), Mr. Zhu Jingyang, and Dr. Zhou Demin[69] - The Audit Committee has reviewed this report and the Group's unaudited condensed consolidated financial statements for the six months ended June 30, 2025[69] Auditor The company's external auditor, Ernst & Young, has conducted an independent review of the Group's interim financial information for the reporting period in accordance with Hong Kong Standard on Review Engagements 2410 issued by the Hong Kong Institute of Certified Public Accountants - The company's external auditor is Ernst & Young[70] - An independent review of the Group's interim financial information for the reporting period has been conducted in accordance with Hong Kong Standard on Review Engagements 2410[70] Use of Proceeds from Global Offering The company's H-shares were listed on the Stock Exchange on September 19, 2025, with net proceeds from the global offering amounting to approximately HKD 1,669.92 million, which, as of the Latest Practicable Date, remained unutilized, with detailed plans for their use, primarily for the development of core products and other candidate products, as well as working capital - The company's H-shares were listed on the Stock Exchange on September 19, 2025[71] - Net proceeds from the global offering amounted to approximately HKD 1,669.92 million[71] - As of the Latest Practicable Date, the company had not utilized any portion of the net proceeds from the global offering[71] Intended Use of Net Proceeds from Global Offering | Use | Allocation (HKD million) | Percentage of Total Net Proceeds | Proposed Timeline for Use | | :--- | :--- | :--- | :--- | | Funding for further development of core products GFH925 and GFH375 | 1,185.64 | 71.0% | | | - Funding for GFH925 clinical development | 551.07 | 33.0% | December 31, 2029 | | - Funding for GFH375 clinical development in China | 634.57 | 38.0% | December 31, 2028 | | Funding for development of other candidate products (e.g., GFH312, GFS202A, GFH276, GFS784, and other preclinical candidates) | 317.28 | 19.0% | December 31, 2030 | | Working capital and other general corporate purposes | 166.99 | 10.0% | December 31, 2028 | | Total | 1,669.92 | 100.0% | | Dividends The Board did not recommend the distribution of an interim dividend for the six months ended June 30, 2025 - The Board did not recommend the distribution of an interim dividend for the six months ended June 30, 2025[73] Interests and Short Positions of Directors, Supervisors, and Chief Executive in Shares, Underlying Shares, and Debentures of the Company or Any Associated Corporation As the company was not listed on the Stock Exchange as of June 30, 2025, Sections 7 and 8 of Part XV and Section 352 of the Securities and Futures Ordinance are not applicable, with relevant interests and short positions to be disclosed in the company's future annual reports - As the company was not listed on the Stock Exchange as of June 30, 2025, relevant provisions of the Securities and Futures Ordinance are not applicable[74] - Interests and short positions of directors, supervisors, and chief executive in shares, underlying shares, and debentures of the company or any associated corporation will be disclosed in the company's future annual reports[74] Interests and Short Positions of Substantial Shareholders in Shares and Underlying Shares As the company was not listed on the Stock Exchange as of June 30, 2025, Sections 2 and 3 of Part XV and Section 336 of the Securities and Futures Ordinance are not applicable to substantial shareholders, with relevant interests and short positions to be disclosed in the company's future annual reports - As the company was not listed on the Stock Exchange as of June 30, 2025, relevant provisions of the Securities and Futures Ordinance are not applicable to substantial shareholders[75] - Interests or short positions of substantial shareholders in shares and underlying shares will be disclosed in the company's future annual reports[75] Pre-IPO Share Incentive Scheme The company's pre-IPO share incentive scheme, adopted in 2020 and revised in 2023, has seen all granted awards vested and exercised, with no new incentives to be granted post-listing, and the scheme will not cause any dilution to the company's shareholders' holdings - The company adopted the pre-IPO share incentive scheme in 2020, which was revised and restated in July 2023[76] - All awards granted under the pre-IPO share incentive scheme have vested and been exercised, and no new incentives will be granted post-listing[76] - The pre-IPO share incentive scheme will not cause any dilution to the company's shareholders' holdings post-listing[76] Events After the Reporting Period The most significant event after the reporting period was the listing of the company's H-shares on the Main Board of the Stock Exchange on September 19, 2025, with net proceeds from the global offering of approximately HKD 1,669.92 million, and other than this, as of the Latest Practicable Date, the company was not aware of any other material events that might affect the Group - On September 19, 2025, the company's H-shares were listed on the Main Board of the Stock Exchange[78] - Net proceeds from the global offering amounted to approximately HKD 1,669.92 million[78] - Except as disclosed in this report, from June 30, 2025, up to the Latest Practicable Date, the company was not aware of any other material events that might affect the Group[78] Independent Review Report Ernst & Young conducted an independent review of GenFleet Therapeutics (Shanghai) Co., Ltd.'s interim condensed consolidated financial information for the six months ended June 30, 2025, in accordance with Hong Kong Standard on Review Engagements 2410, concluding that nothing came to their attention that caused them to believe the interim financial information was not prepared, in all material respects, in accordance with International Accounting Standard 34 - Ernst & Young has reviewed the interim financial information presented on pages 26 to 49[80] - The review was conducted in accordance with Hong Kong Standard on Review Engagements 2410 issued by the Hong Kong Institute of Certified Public Accountants[81] - The conclusion was that nothing came to the auditor's attention that caused them to believe the interim financial information was not prepared, in all material respects, in accordance with International Accounting Standard 34[82] Interim Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income This statement presents the condensed consolidated profit or loss and other comprehensive income for the six months ended June 30, 2025, and the prior corresponding period, showing that the company recorded revenue of RMB 88.74 million for the first time, but the loss for the period expanded to RMB 698.60 million, primarily due to the negative impact of fair value changes in redeemable equity shares Interim Condensed Consolidated Profit or Loss and Other Comprehensive Income (RMB thousand) | Metric | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Revenue | 88,744 | – | | Cost of Sales | (16,924) | – | | Other Income and Gains | 8,180 | 11,268 | | R&D Costs | (122,435) | (186,001) | | Administrative Expenses | (36,952) | (18,509) | | Other Expenses | (292) | (3) | | Finance Costs | (3,026) | (14,597) | | Loss before fair value changes of redeemable equity shares | (82,705) | (207,842) | | Fair value changes of redeemable equity shares | (615,873) | (241,461) | | Loss before income tax | (698,578) | (449,303) | | Income tax expense | (22) | – | | Loss for the period | (698,600) | (449,303) | | Total comprehensive loss for the period | (698,018) | (449,563) | | Basic and diluted loss per share (RMB) | (27.02) | (18.02) | Interim Condensed Consolidated Statement of Financial Position This statement presents the condensed consolidated financial position as of June 30, 2025, and December 31, 2024, showing that the company's net current liabilities significantly increased to RMB 2,607.35 million, primarily due to a substantial rise in redeemable equity shares to RMB 2,829.99 million, leading to a further expansion of the equity deficit Interim Condensed Consolidated Financial Position (RMB thousand) | Metric | As of June 30, 2025 | As of December 31, 2024 | | :--- | :--- | :--- | | Total non-current assets | 33,826 | 38,573 | | Total current assets | 518,098 | 568,248 | | Total current liabilities | 3,125,445 | 2,493,429 | | Net current liabilities | (2,607,347) | (1,925,181) | | Total assets less current liabilities | (2,573,521) | (1,886,608) | | Total non-current liabilities | 68,059 | 69,653 | | Net liabilities | (2,641,580) | (1,956,261) | | Total equity deficit | (2,641,580) | (1,956,261) | | Redeemable equity shares | 2,829,994 | 2,214,121 | Interim Condensed Consolidated Statement of Changes in Equity This statement presents the condensed consolidated changes in equity for the six months ended June 30, 2025, and the prior corresponding period, showing that as of June 30, 2025, the total equity deficit was RMB 2,641.58 million, primarily reflecting a loss for the period of RMB 698.60 million and share-based payment expenses of RMB 12.70 million Interim Condensed Consolidated Changes in Equity (RMB thousand) | Metric | As of January 1, 2025 | Exchange differences on translation | Loss for the period | Share-based payment | As of June 30, 2025 | | :--- | :--- | :--- | :--- | :--- | :--- | | Share capital | 26,774 | – | – | – | 26,774 | | Share premium | 714,853 | – | – | – | 714,853 | | Share-based payment reserve | 65,465 | – | – | 12,699 | 78,164 | | Other reserves | (1,459,093) | – | – | – | (1,459,093) | | Exchange fluctuation reserve | (1,475) | 582 | – | – | (893) | | Accumulated losses | (1,302,785) | – | (698,600) | – | (2,001,385) | | Total deficit | (1,956,261) | 582 | (698,600) | 12,699 | (2,641,580) | Interim Condensed Consolidated Statement of Cash Flows This statement presents the condensed consolidated cash flows for the six months ended June 30, 2025, and the prior corresponding period, showing that net cash flow used in operating activities was a negative RMB 50.49 million, an improvement from the prior corresponding period, with investing activities generating cash inflow of RMB 13.13 million, while cash inflow from financing activities significantly decreased to RMB 21.46 million Interim Condensed Consolidated Cash Flows (RMB thousand) | Metric | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Net cash flows used in operating activities | (50,492) | (162,963) | | Net cash flows from/(used in) investing activities | 13,132 | (102,653) | | Net cash flows from financing activities | 21,464 | 211,387 | | Net decrease in cash and cash equivalents | (15,896) | (54,229) | | Cash and cash equivalents at end of period | 346,525 | 279,030 | Notes to the Interim Condensed Consolidated Financial Information This section provides detailed notes to the interim condensed consolidated financial information, covering company information, basis of preparation, operating segment information, revenue recognition, various expenses, taxation, loss per share, balance sheet items, changes and valuation assumptions for redeemable equity shares, share capital, commitments, related party transactions, and events after the reporting period, offering deeper explanations and background for the financial statements Company Information GenFleet Therapeutics (Shanghai) Co., Ltd. was established in mainland China on August 23, 2017, as a clinical-stage biotechnology company primarily engaged in drug research, development, and commercialization - The company was established in mainland China on August 23, 2017[92] - The Group is primarily engaged in drug research, development, and commercialization[93] Basis of Preparation The interim condensed consolidated financial information is prepared in accordance with International Accounting Standard 34 and presented in RMB, and despite recording net current liabilities as of June 30, 2025, the Board, based on prudent budget assessments, believes the company has sufficient working capital to meet its current obligations, thus deeming the preparation of financial statements on a going concern basis appropriate - The interim condensed consolidated financial information has been prepared in accordance with International Accounting Standard 34 "Interim Financial Reporting"[94] - The Group recorded net current liabilities of RMB 2,607,347,000 as of June 30, 2025, primarily due to redeemable equity shares[96] - The Board has prepared full-speed and backbone budget plans and is satisfied that the Group will have sufficient working capital to meet its current obligations, thus deeming the preparation of financial statements on a going concern basis appropriate[97][98] - The redemption features of the redeemable equity shares ceased to be effective from the date prior to the listing application and will be reinstated upon the occurrence of specific listing failure events[96] Operating Segment Information The Group is engaged in biopharmaceutical R&D and is considered a single reportable segment, with most revenue derived from US customers, while almost all non-current assets are located in mainland China - The Group is engaged in biopharmaceutical R&D and is considered a single reportable segment[99] - Most of the Group's revenue is derived from US customers[100] - Almost all of the Group's non-current assets are located in mainland China[101] Revenue For the six months ended June 30, 2025, the company's revenue was RMB 88.74 million, primarily from intellectual property licensing (RMB 82.88 million), with most revenue recognized at a point in time, and the notes detail licensing agreements for GFH925 and GFH375, including the termination of GFH925's overseas option and related fee payments, and the collaboration with Verastem for GFH375 Revenue Analysis (RMB thousand) | Type of Service | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Intellectual property licensing | 82,876 | – | | Others | 5,868 | – | | Total | 88,744 | – | | Timing of revenue recognition: | | | | Transferred at a point in time | 87,464 | – | | Transferred over time | 1,280 | – | - In January 2024, the company entered into a supplemental agreement with Innovent Biologics to terminate the overseas option under the GFH925 licensing agreement, requiring the company to pay Innovent Biologics a non-refundable termination fee of USD 20,000,000 in installments[104] - In January 2025, Verastem exercised one of three options related to the Group's GFH375, obtaining an exclusive license to develop and commercialize GFH375 outside Greater China[105] Transaction Price Allocated to Remaining Performance Obligations (RMB thousand) | Amount expected to be recognized as revenue | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Within one year | 5,837 | – | | After one year | 11,944 | 14,360 | | Total | 17,781 | 14,360 | Other Income and Gains For the six months ended June 30, 2025, other income and gains amounted to RMB 8.18 million, a decrease from RMB 11.27 million in the prior corresponding period, primarily due to reduced bank interest income and the absence of net exchange differences, fair value gains on financial assets, and lease revaluation gains present in the prior period Other Income and Gains Details (RMB thousand) | Item | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Government grants | 891 | 800 | | Bank interest income | 7,289 | 8,172 | | Net exchange differences | – | 1,520 | | Fair value gains on financial assets at fair value through profit or loss | – | 288 | | Lease revaluation gains | – | 488 | | Total | 8,180 | 11,268 | Loss Before Income Tax The Group's loss before income tax has been deducted or included with various expenses, including cost of inventories sold of RMB 16.04 million, listing expenses of RMB 17.03 million, and total staff costs of RMB 49.76 million (of which share-based payment expenses were RMB 12.70 million) Items Deducted from/(Included in) L