派格生物医药(02565) - 2025 - 中期业绩

Financial Summary Provides an overview of the company's financial performance and position, highlighting key changes in profitability and balance sheet metrics Operating Results For the six months ended June 30, 2025, the company significantly narrowed its operating and period losses, with a reduction in loss per share Operating Results | Indicator | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Operating Loss | (92,135) | (154,330) | | Loss for the Period | (93,672) | (155,490) | | Loss per Share – Basic and Diluted (RMB) | (0.25) | (0.42) | Financial Position As of June 30, 2025, the company's total assets and total equity substantially increased, while current liabilities decreased, indicating an improved financial structure Financial Position | Indicator | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Non-current Assets | 37,268 | 28,063 | | Current Assets | 346,079 | 190,294 | | Total Assets | 383,347 | 218,357 | | Non-current Liabilities | 10,363 | 3,221 | | Current Liabilities | 112,535 | 157,666 | | Total Liabilities | 122,898 | 160,887 | | Total Equity | 260,449 | 57,470 | Business Highlights The company achieved significant progress in technology innovation, product pipeline, and business operations in the US and China, building a pipeline of six drug candidates for chronic diseases, with a core focus on metabolic disorders Core Strategy and Pipeline The company has made significant strides in technology innovation, product pipeline, and business operations in the US and China, establishing a pipeline of six drug candidates for chronic diseases, with a core focus on metabolic disorders - The company has successfully built a pipeline matrix covering 6 drug candidates for chronic diseases[6] - The core strategy focuses on treating metabolic diseases and their complications, with multiple candidate drugs possessing both "First-in-Class" (FIC) and "Best-in-Class" (BIC) potential[6] Core Product PB-119 Progress Core product PB-119 (Vepanapeptide Injection) entered the NMPA supplementary review stage in May 2025, with market approval expected in Q3 2025, and commercial production preparations and differentiated market strategies are complete - PB-119 officially entered the National Medical Products Administration (NMPA) supplementary review stage on May 22, 2025[6] - New Drug Application (NDA) approval is expected in Q3 2025, with commercial production preparations already completed[7] - The market strategy will emphasize its differentiated value of "high safety, long-acting glucose control advantages, and potential cardiovascular benefits," while actively implementing market access, building full-channel coverage, exploring innovative payment models, and strengthening academic promotion[8][10] Other Pipeline Progress All clinical-stage projects are progressing as planned, and preclinical projects have met their development goals, laying the foundation for subsequent IND applications - Clinical research stage projects are strictly adhering to R&D plans and quality standards, systematically advancing clinical trial enrollment, data collection, and analysis[9] - Preclinical research stage projects have achieved their R&D milestones as planned, laying the foundation for subsequent Investigational New Drug (IND) applications[9] I. Overview Provides a high-level introduction to the company's mission, strategic focus, and key product development areas Company Profile and Strategic Focus PegBio, established in 2008, specializes in the independent R&D of innovative therapies (peptides and small molecules) for chronic diseases, focusing on metabolic disorders with one core product and five candidate products - The company was established in 2008, focusing on independent research and development of innovative therapies for chronic diseases, primarily peptides and small molecules, with a key focus on metabolic disorders[11] - It has independently developed one core product and five other candidate products to address market opportunities in Type 2 Diabetes Mellitus (T2DM), obesity, Non-alcoholic Steatohepatitis (NASH), Opioid-Induced Constipation (OIC), and Congenital Hyperinsulinism (CHI)[11] II. Business Review Reviews the company's product pipeline, R&D efforts, manufacturing capabilities, commercialization strategies, and intellectual property Products and Pipeline The company focuses on differentiated therapies for chronic and metabolic diseases, having developed a diverse pipeline of six candidate products by June 30, 2025, with three in clinical trials and one with IND approval, utilizing PEG technology - As of June 30, 2025, the company has developed a diverse pipeline consisting of six candidate products, with three currently in clinical trials and one having received IND approval[12] - The company applies Polyethylene Glycol (PEG) technology to its candidate products to optimize their physicochemical properties, achieving long-acting efficacy and selective targeting[12] Candidate Drug Development Status (as of June 30, 2025) | Candidate Drug | MoA/Target | Indication | Current Status/Future Milestones | | :--- | :--- | :--- | :--- | | PB-119 | Long-acting GLP-1 Receptor Agonist | T2DM (monotherapy/combination therapy), Overweight or Obesity | Expected to be approved for launch in China as early as Q3 2025; Ib/IIa clinical trial for obesity is being initiated in China; Phase III clinical trial for T2DM cardiovascular benefits to be initiated in China in 2026 | | PB-718 | Long-acting GLP-1/GCG Dual Receptor Agonist | Overweight or Obesity, NASH | Subject follow-up for Ib/IIa clinical trial completed in China; Phase IIb clinical trial expected to start in 2025; Phase I clinical trial in the US completed in May 2022 (NASH) | | PB-1902 | Opioid Receptor Antagonist | OIC | Phase I clinical trial completed in China in January 2022; Phase II clinical trial expected to start in China in 2025 | | PB-722 | GCG Receptor Agonist | Congenital Hyperinsulinism | IND approved by NMPA in May 2023; Phase I clinical trial to be initiated in China in 2026 | | PB-2301 | GLP-1/GIP Dual Receptor Agonist | T2DM/Overweight or Obesity/NASH | IND application expected to be submitted in China in 2026 | | PB-2309 | GLP-1/GIP/GCG Triple Receptor Agonist | T2DM/Overweight or Obesity/NASH | IND application expected to be submitted in China in 2025 | Core Product PB-119 PB-119, an independently developed long-acting GLP-1 receptor agonist for T2DM and obesity, offers once-weekly dosing via PEGylation, good safety, and no titration, with NDA accepted in September 2023 and expected approval in 2025 - PB-119 is an independently developed long-acting GLP-1 receptor agonist, primarily for first-line treatment of T2DM and obesity, enabling once-weekly dosing through PEGylation[14] - PB-119 features a single dosage form, requires no dose titration, and demonstrates good safety with rapid, significant, and sustained efficacy[14] - The NMPA accepted the NDA for PB-119 in China for T2DM treatment in September 2023, with approval and commercial launch anticipated in 2025[15] - The company plans to initiate Phase III clinical trials in 2025 for PB-119 in combination therapy with basal insulin and SGLT-2 inhibitors, as well as a Phase III clinical trial to evaluate cardiovascular outcomes in T2DM patients[16] - Recruitment for the Ib/IIa clinical trial of PB-119 for obesity treatment was completed in June 2024[16] PB-718, a Long-Acting GLP-1/GCG Dual Receptor Agonist PB-718, a novel long-acting GLP-1/GCG dual receptor agonist for obesity and NASH, provides synergistic effects with significant weight loss and appetite reduction, and once-weekly dosing via PEGylation, having completed US Phase I and China Ib/IIa follow-up - PB-718 is a novel long-acting GLP-1/Glucagon (GCG) dual receptor agonist, primarily for the treatment of obesity and NASH[21] - This drug produces synergistic effects by dually activating GLP-1 and GCG receptors, characterized by significant weight loss, reduced appetite, and decreased hepatic lipid accumulation[21] - Utilizing PEGylation technology to extend its half-life, it allows for once-weekly dosing, with Phase I clinical trials completed in the US and subject follow-up for Ib/IIa clinical trials completed in China[22] PB-1902, a Potential First-in-Class Oral Selective Opioid Receptor Antagonist for OIC PB-1902 is a potential first-in-class oral selective opioid receptor antagonist in China for opioid-induced constipation (OIC), designed to relieve constipation without compromising analgesia, having completed two Phase I studies and planning Phase II in China for 2025 - PB-1902 is a potential first-in-class oral selective opioid receptor antagonist in China for the treatment of Opioid-Induced Constipation (OIC)[24] - The drug aims to effectively alleviate bowel dysfunction without diminishing the central analgesic effects of opioid medications[24] - Two Phase I clinical studies have been completed, demonstrating good safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics, with a Phase II clinical trial planned to commence in China in 2025[24] PB-722, a GCG Receptor Agonist in Development for Congenital Hyperinsulinism PB-722, a GCG receptor agonist for congenital hyperinsulinism, received FDA Orphan Drug Designation in May 2021 and NMPA IND approval in May 2023, becoming the first candidate for this indication in China, with Phase I planned for 2026 and Phase II for 2027 - PB-722, a GCG receptor agonist for the treatment of congenital hyperinsulinism, received FDA Orphan Drug Designation in May 2021[25] - In May 2023, the NMPA approved its IND application, making it the first candidate drug approved in China for the treatment of congenital hyperinsulinism[25] - Phase I clinical trials are planned to commence in 2026, with Phase II clinical trials anticipated to start in 2027[25] PB-2301, a GLP-1/GIP Dual Receptor Agonist for T2DM, NASH, and Obesity PB-2301 is a GLP-1/GIP dual receptor agonist for T2DM, NASH, and obesity, currently undergoing preclinical studies with an IND application to NMPA expected in 2026 - PB-2301 is a GLP-1/Glucose-dependent Insulinotropic Polypeptide (GIP) dual receptor agonist for the treatment of T2DM, NASH, and obesity[26] - Multiple preclinical studies are currently underway, with an IND application to the NMPA planned for 2026[26] PB-2309, a GLP-1/GIP/GCG Triple Receptor Agonist for T2DM, NASH, and Obesity PB-2309 is a GLP-1/GIP/GCG triple receptor agonist for T2DM, NASH, and obesity, currently undergoing preclinical studies with an IND application to NMPA expected in 2025 - PB-2309 is a GLP-1/GIP/GCG triple receptor agonist for the treatment of T2DM, NASH, and obesity[28] - Multiple preclinical studies are currently underway, with an IND application to the NMPA planned for 2025[28] Research and Development The company possesses an experienced R&D team focused on chronic and metabolic diseases, with independent drug discovery capabilities and support for drug discovery, clinical R&D, and regulatory affairs, with R&D expenses of RMB 26.3 million for the six months ended June 30, 2025 - The company's R&D team possesses extensive expertise and development experience in chronic and metabolic diseases, with independent drug discovery capabilities including identifying medical needs, compound design optimization, efficacy evaluation, and formulation development[29] R&D Expenses | Indicator | H1 2025 (RMB millions) | H1 2024 (RMB millions) | | :--- | :--- | :--- | | R&D Expenses | 26.3 | 64.0 | Chemistry, Manufacturing, and Controls ("CMC") The company's experienced CMC team is responsible for process development, production, and quality management during drug development, relying on CDMO partners for preclinical and clinical production due to the absence of commercial-scale manufacturing facilities - The CMC team is highly experienced in process development, production, and quality management, responsible for developing safe, robust, and economically viable production processes while ensuring quality compliance with regulatory requirements[31] - The company currently has no commercial-scale manufacturing facilities and no plans to establish its own, instead relying on CDMO partners for preclinical and clinical research production and future commercial supply[31] Commercialization The company currently has no commercialized products, has established an internal marketing team for strategy development, but plans to collaborate with external pharmaceutical companies to maximize product commercial value, while actively exploring overseas markets - As of June 30, 2025, the company has no commercialized products[32] - The company has established an internal marketing team responsible for commercialization strategy and academic marketing, but does not intend to build an internal sales team, planning instead to collaborate with pharmaceutical companies possessing strong commercialization capabilities to leverage their sales networks[32] - For overseas markets, the company plans to develop more specific strategies after PB-119's commercialization in China, having initiated registration pathway planning for the Middle East market and exploring collaboration opportunities with multinational pharmaceutical companies[33] PB-119 Commercialization Preparation To ensure the successful launch of core product PegDac® (PB-119) in the Chinese market, the company has established a comprehensive commercial preparation system, including pre-launch strategy, pricing, academic promotion, patient support, innovative payment, and long-term medical value - The overall pre-launch strategy for PegDac® has been completed, and a scientific, competitive pricing strategy has been established[34] - The company is actively conducting multi-level academic conferences, collaborating with authoritative experts, and preparing core promotional materials and launch event resources[36] - A "Patient Care Program" plan has been developed, the final planning for innovative payment projects is actively progressing, and Investigator-Initiated Trial (IIT) planning has been initiated[35][37] Collaboration Agreement for Commercialization of PB-119 The company's collaboration agreement with a commercialization partner for PB-119 in mainland China terminated in June 2025, with both parties discussing potential new arrangements while the company seeks other partners - The company's collaboration agreement with a commercialization partner for PB-119 in mainland China terminated in June 2025[38] - Both parties are discussing potential new arrangements for PB-119's marketing and commercialization, and the company will also seek other potential partners[38] Intellectual Property Intellectual property is crucial for the company's success, with 83 patents and patent applications as of June 30, 2025, including 13 patents and 15 applications related to core products, all clinical-stage candidates derived from the HECTOR® platform and PEGylation technology - As of June 30, 2025, the company owns 83 patents and patent applications, of which 13 patents and 15 patent applications are related to its core products[39] - All significant patents and patent applications are self-owned, and all clinical-stage candidate drugs are derived from the company's HECTOR® platform and PEGylation technology[39] Future and Outlook Outlines the company's strategic priorities for accelerating core product commercialization, deepening pipeline value, and expanding global partnerships for future growth Accelerating Core Product Commercialization to Benefit Chinese Patients The company will continue to invest resources to support PB-119's NMPA review, aiming for a formal launch in mainland China in Q3 2025, with comprehensive market access and commercialization preparations underway - The core investigational product PB-119 is in a critical stage of NMPA review, and the company will fully advance the review process[41] - The goal is to successfully achieve the formal launch of PB-119 in the mainland China market in Q3 2025[41] - The company has initiated comprehensive market access preparations and commercialization strategies[41] Deepening R&D Pipeline Value, Laying Out Future Growth Drivers The company will continue to invest in R&D, explore existing pipeline potential, and actively advance two early-stage projects with potential "Best-in-Class" (BIC) prospects, aiming to complete preclinical studies and submit IND applications soon - The company will continue to invest in R&D, deeply explore the potential of its existing pipeline, and actively advance two early-stage R&D projects with potential "Best-in-Class" (BIC) prospects[42] - The objective is to complete relevant preparatory work and formally submit Investigational New Drug (IND) applications as soon as possible after the reporting period, aiming for an early entry into the clinical research stage[42] Expanding Global Collaboration Network, Building an International Development Landscape Internationalization is a key long-term strategy, with PB-119 registration pathway planning initiated for the Middle East to expand into Belt and Road countries, while continuously exploring diverse collaboration opportunities with multinational pharmaceutical companies - Internationalization is a crucial long-term strategic direction for the company, which has simultaneously initiated registration pathway planning for its core product PB-119 in the Middle East market[43] - The company will continue to actively explore and evaluate diverse collaboration opportunities with multinational pharmaceutical companies for joint development, in-licensing, or out-licensing of its R&D pipeline[43] III. Financial Review Provides a detailed analysis of the company's financial performance, including losses, expenses, cash flow, and balance sheet items, for the reporting period Overview The company currently has no products approved for commercial sale and incurred operating losses during the reporting period, though total loss decreased year-over-year, with financial performance expected to fluctuate post-PB-119 commercialization - The company currently has no products approved for commercial sale and has not generated any revenue from product sales[44] Total Loss Comparison | Indicator | H1 2025 (RMB millions) | H1 2024 (RMB millions) | | :--- | :--- | :--- | | Total Loss | 93.7 | 155.5 | - The total loss is primarily attributable to R&D expenses and administrative expenses, and financial performance is expected to fluctuate after PB-119's commercialization[44] Loss for the Period For the six months ended June 30, 2025, net loss was RMB 93.7 million, a decrease of RMB 61.8 million from the prior year, primarily due to reduced share-based compensation and lower R&D expenses as PB-119 entered the NDA stage - The net loss for the six months ended June 30, 2025, was RMB 93.7 million, a decrease of RMB 61.8 million compared to the same period last year[45] - The reduction in loss was primarily due to decreased share-based compensation expenses and lower R&D expenses as PB-119 entered the NDA stage[45] Non-HKFRS Measures The company provides adjusted net loss as a supplementary financial measure, excluding non-cash items like share-based compensation, to better reflect core business performance, with adjusted net loss narrowing to RMB 51.1 million for the six months ended June 30, 2025 - Adjusted net loss refers to the net loss excluding the impact of non-cash items, specifically share-based compensation expenses[46] Adjusted Net Loss | Indicator | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Loss for the Period | (93,672) | (155,490) | | Add: Share-based Compensation Expenses | 42,572 | 87,660 | | Adjusted Net Loss | (51,100) | (67,830) | Revenue The company currently has no products approved for commercial sale and therefore generated no revenue from product sales - The company currently has no products approved for commercial sale and has not generated any revenue from product sales[49] Research and Development Expenses For the six months ended June 30, 2025, R&D expenses were RMB 26.3 million, a decrease of RMB 37.7 million from the prior year, mainly due to reduced share-based compensation and lower R&D costs as PB-119 entered the NDA stage R&D Expenses Breakdown | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Third-party Contract Expenses | 13,854 | 20,859 | | Staff Costs | 8,318 | 11,112 | | Raw Materials and Consumables Costs | 1,490 | 7,081 | | Share-based Compensation Expenses | 1,143 | 23,417 | | Depreciation and Amortization Expenses | 526 | 832 | | Other | 963 | 737 | | Total | 26,294 | 64,038 | - R&D expenses decreased by RMB 37.7 million, primarily due to a RMB 22.3 million reduction in share-based compensation expenses (resulting from the cancellation and modification of restricted share unit vesting conditions) and lower R&D costs as PB-119 entered the NDA stage[50] Administrative Expenses For the six months ended June 30, 2025, administrative expenses were RMB 61.3 million, a decrease of RMB 30.0 million from the prior year, mainly due to reduced share-based compensation and lower listing expenses Administrative Expenses Breakdown | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Share-based Compensation Expenses | 41,429 | 64,243 | | Staff Costs | 6,356 | 7,478 | | Professional and Consulting Service Fees | 10,139 | 16,972 | | Depreciation and Amortization Expenses | 993 | 360 | | Other | 2,337 | 2,283 | | Total | 61,254 | 91,336 | - Administrative expenses decreased by RMB 30.0 million, primarily due to a RMB 22.8 million reduction in share-based compensation expenses (due to the cancellation and modification of restricted share units) and lower listing expenses following the completion of the IPO in May 2025[51] Liquidity and Capital Resources The company primarily relies on equity financing for liquidity, with negative cash flow from operating activities during the reporting period; cash and cash equivalents increased by RMB 237.6 million for the six months ended June 30, 2025, mainly due to IPO proceeds - The company relies on equity financing as its primary source of liquidity, with negative cash flow generated from operating activities during the reporting period[52] Cash Flow Statement Summary | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | (78,035) | (106,194) | | Net Cash From Investing Activities | 86,841 | 72,988 | | Net Cash From Financing Activities | 228,805 | 7,816 | | Net Increase/(Decrease) in Cash and Cash Equivalents | 237,611 | (25,390) | | Cash and Cash Equivalents at End of Period | 264,529 | 51,757 | Net Cash Used in Operating Activities For the six months ended June 30, 2025, net cash used in operating activities was RMB 78.0 million, primarily due to R&D and administrative expenditures - For the six months ended June 30, 2025, net cash used in operating activities was RMB 78.0 million, primarily due to R&D and administrative expenditures[54] Net Cash From Investing Activities For the six months ended June 30, 2025, net cash from investing activities was RMB 86.8 million, primarily due to the redemption of financial assets - For the six months ended June 30, 2025, net cash from investing activities was RMB 86.8 million, mainly due to the redemption of financial assets[55] Net Cash From Financing Activities For the six months ended June 30, 2025, net cash from financing activities was RMB 228.8 million, primarily due to proceeds from the IPO - For the six months ended June 30, 2025, net cash from financing activities was RMB 228.8 million, primarily due to proceeds from the IPO[56] Cash and Cash Equivalents As of June 30, 2025, cash and cash equivalents totaled RMB 264.5 million, an increase of RMB 236.1 million from December 31, 2024, primarily due to net IPO proceeds - As of June 30, 2025, the Group's cash and cash equivalents amounted to RMB 264.5 million, an increase of RMB 236.1 million from RMB 28.4 million as of December 31, 2024[57] - This increase was primarily due to net proceeds from the IPO[57] Borrowings and Gearing Ratio As of June 30, 2025, total borrowings decreased to RMB 75.1 million, and the gearing ratio significantly dropped to 32.3%, indicating a substantial improvement in financial leverage - As of June 30, 2025, the Group's total borrowings (including interest-bearing borrowings) amounted to RMB 75.1 million, a decrease of RMB 24.9 million from RMB 100.0 million as of December 31, 2024[58] - All interest-bearing borrowings are unsecured, due within one year, and carry interest rates ranging from 2.5% to 2.9%[59] - The gearing ratio was 32.3% as of June 30, 2025, a significant decrease from 176.6% as of December 31, 2024[59] Lease Liabilities Lease liabilities increased from RMB 1.5 million as of December 31, 2024, to RMB 9.0 million as of June 30, 2025, primarily due to the lease of new office premises in Hangzhou - Lease liabilities increased from RMB 1.5 million as of December 31, 2024, to RMB 9.0 million as of June 30, 2025[60] - This increase was primarily due to the company leasing new office premises in Hangzhou during the reporting period[60] Material Investments As of June 30, 2025, the company held two transferable bank time deposits with a total fair value of approximately RMB 53.23 million, representing 5% or more of total assets, but had no other material investments - The company holds two transferable bank time deposits: one with a principal amount of RMB 20 million, maturing on April 4, 2026, with a fair value of approximately RMB 21.39 million[66] - The other has a total principal amount of RMB 30 million, maturing on August 1, 2026, with a total fair value of approximately RMB 31.84 million[66] - Except as disclosed above, the company held no other material investments representing 5% or more of the Group's total assets during the reporting period[61] Material Acquisitions and Disposals For the six months ended June 30, 2025, the company had no material acquisitions or disposals of subsidiaries, associates, or joint ventures - For the six months ended June 30, 2025, the company had no material acquisitions or disposals of subsidiaries, associates, or joint ventures[62] Foreign Exchange Risk The company's entities primarily operate in China, with some bank balances denominated in foreign currencies, exposing them to foreign currency risk; currently, there are no hedging instruments or policies, but management will monitor and consider appropriate measures - The Group's entities operate in the People's Republic of China, and certain bank balances are denominated in foreign currencies, exposing them to foreign currency risk[63] - As of June 30, 2025, the Group had no foreign exchange hedging instruments or foreign currency hedging policies, but management will continue to monitor and consider appropriate hedging measures if necessary in the future[63] Capital Expenditure For the six months ended June 30, 2025, total capital expenditure was approximately RMB 0.2 million, primarily for renovation design fees and office equipment - For the six months ended June 30, 2025, the Group's total capital expenditure was approximately RMB 0.2 million, primarily for renovation design fees and office equipment payments[64] Charge on Assets As of June 30, 2025, and December 31, 2024, the company had no charges on any assets - As of June 30, 2025, and December 31, 2024, the Group had no charges on any assets[65] Contingent Liabilities As of June 30, 2025, the company had no material contingent liabilities, with no significant changes or arrangements up to the announcement date - As of June 30, 2025, the Group had no material contingent liabilities[67] Employees and Remuneration Policy As of June 30, 2025, the company had 58 employees, with a remuneration policy including salaries, bonuses, provident funds, social insurance, and other benefits, along with continuous education and training programs to maintain staff quality and motivation - As of June 30, 2025, the company had a total of 58 employees, a decrease from 64 as of December 31, 2024[68] - Employee remuneration includes salaries, bonuses, provident funds, social insurance contributions, and other benefits, with social insurance funds and housing provident funds paid in accordance with applicable laws and regulations[68] - The company provides continuous education and training programs, including internal training, and offers competitive salaries, bonuses, and share-based payments as incentives and benefits to employees[69] Future Plans for Material Investments and Capital Assets As of the announcement date, the company had not authorized any plans for material investments or acquisitions of capital assets - As of the date of this announcement, the company has not authorized any plans for material investments or acquisitions of capital assets[70] IV. Key Risks and Uncertainties Details the primary operational risks faced by the company, including market competition, intellectual property protection, regulatory uncertainties, and financial sustainability Key Risk Factors The company faces multiple operational risks, including intense market competition, insufficient intellectual property protection, uncertainties in PB-119 approval and sales, lengthy and costly drug development, unfulfilled safety/efficacy, adverse events, off-label use risks, third-party partner performance, smaller-than-expected market size, and continued losses - The company may face intense competition and rapid technological changes, with competitors potentially developing more advanced or effective therapies[71] - It may be unable to successfully obtain or maintain adequate patent protection for its candidate drugs through intellectual property[71] - The business, financial condition, operating results, and prospects are largely dependent on the successful approval and sale of PB-119[71] - The clinical drug development cycle is lengthy, capital-intensive, and uncertain, potentially preventing the commercialization of candidate drugs[71] - Candidate drugs may cause adverse events or fail to demonstrate safety and efficacy satisfactory to regulatory authorities[71] - There is a performance risk associated with third-party partners, which could affect regulatory approval or commercialization of candidate drugs[71] - The market size for candidate drugs may be smaller than anticipated, and the company has incurred significant net losses since its inception, which may continue in the future[76] Corporate Governance and Other Information Provides information on the company's corporate governance practices, interim dividends, compliance with trading codes, audit committee review, and IPO proceeds utilization Interim Dividend The Board of Directors resolved not to recommend an interim dividend for the six months ended June 30, 2025 - The Board of Directors resolved not to recommend an interim dividend for the six months ended June 30, 2025 (for the six months ended June 30, 2024: nil)[73] Compliance with the Standard Code for Securities Transactions The company adopted a standard code for securities transactions by directors, supervisors, and relevant employees, confirming compliance by all directors and supervisors since the listing date, with no reported employee breaches - The company has adopted a standard code to regulate all dealings in the company's securities by directors, supervisors, and relevant employees since the listing date[74] - All directors and supervisors have confirmed their compliance with the standard code from the listing date up to the date of this announcement, and to the company's knowledge, no employee breaches of the standard code have occurred[74] Compliance with the Corporate Governance Code The company adopted and applied the Corporate Governance Code, complying with all applicable code provisions since the listing date, except for the non-segregation of Chairman and CEO roles - The company has adopted and applied the principles and code provisions set out in Part 2 of the Corporate Governance Code as its own code of corporate governance practices[75] - From the listing date up to the date of this announcement, the company has complied with all applicable code provisions of the Corporate Governance Code, except for code provision C.2.1 (which stipulates that the roles of Chairman and Chief Executive Officer should be separate)[75] Chairman and Chief Executive Officer Roles Company Chairman and CEO roles are concurrently held by Dr. Michael Min XU, an arrangement the Board believes ensures consistent internal leadership, efficient strategic planning, and improved communication, which will be continuously reviewed - The roles of Chairman and Chief Executive Officer are concurrently held by Dr. Michael Min XU, which deviates from Corporate Governance Code provision C.2.1[77] - The Board believes this arrangement facilitates consistent internal leadership for the Group, enhances the efficiency of the Board's overall strategic planning and execution, and promotes information exchange between management and the Board[77] Audit Committee and Review of Interim Results The company established an Audit Committee, comprising three directors with Ms. Fan Xinpeng as Chair, which reviewed and concurred with the adopted accounting principles and practices, and the unaudited condensed consolidated interim financial results for the six months ended June 30, 2025 - The Audit Committee comprises three directors, with Ms. Fan Xinpeng serving as Chair, and its primary responsibilities include recommending the appointment or removal of external auditors, monitoring their independence, guiding internal audit work, reviewing financial information, and assessing the effectiveness of internal controls[78] - The Audit Committee has reviewed and concurred with the accounting principles and practices adopted by the Group, and has reviewed the unaudited condensed consolidated interim financial results for the six months ended June 30, 2025[79] Purchase, Sale or Redemption of the Company's Listed Securities Neither the company nor its subsidiaries purchased, sold, or redeemed any of its listed securities from the listing date to the announcement date, and no treasury shares were held as of June 30, 2025 - From the listing date up to the date of this announcement, neither the company nor any of its subsidiaries purchased, sold, or redeemed any of the company's listed securities[80] - As of June 30, 2025, the company held no treasury shares, and no shares had been repurchased but were awaiting cancellation[80] Use of Proceeds from Global Offering The company listed on the HKEX on May 19, 2025, raising net proceeds of approximately RMB 212.6 million from the global offering; as of June 30, 2025, all proceeds remained unutilized and will be allocated as per the prospectus for PB-119 commercialization, indication expansion, and PB-718 development - The company was listed on the Stock Exchange of Hong Kong Limited (HKEX) on May 19, 2025, with net proceeds from the global offering amounting to approximately RMB 212.6 million[81] Use of Proceeds from Global Offering and Expected Timetable | Use of Proceeds | Approximate Percentage of Total Net Proceeds (%) | Planned Allocation of Net Proceeds (RMB millions) | Net Proceeds Utilized During Reporting Period (RMB millions) | Unutilized Net Proceeds (as of June 30, 2025) (RMB millions) | Expected Timetable for Use of Net Proceeds | | :--- | :--- | :--- | :--- | :--- | :--- | | Commercialization and Indication Expansion of our Core Product PB-119 | 50.2 | 106.7 | – | 106.7 | Expected to be fully utilized by end of 2027 | | Further Development of our Key Product PB-718 | 34.5 | 73.3 | – | 73.3 | Expected to be fully utilized by end of 2027 | | Ongoing and Planned R&D for our Other Pipeline Candidate Products | 5.3 | 11.3 | – | 11.3 | Expected to be fully utilized by end of 2026 | | Business Development Activities and Strengthening our Overseas Business | 1.0 | 2.1 | – | 2.1 | Expected to be fully utilized by end of 2026 | | Working Capital and Other General Corporate Purposes | 9.0 | 19.2 | – | 19.2 | Expected to be fully utilized by end of 2025 | | Total | 100 | 212.6 | – | 212.6 | | Events After Reporting Period As of the announcement date, no significant events requiring additional disclosure or adjustment occurred after the reporting period - As of the date of this announcement, no significant events requiring additional disclosure or adjustment have occurred after the reporting period[83] Continuing Disclosure Obligations under Listing Rules The company has no disclosure obligations under Listing Rules 13.20, 13.21, and 13.22 - The company has no disclosure obligations under Listing Rules 13.20, 13.21, and 13.22[84] Publication of Interim Results and 2025 Interim Report This interim results announcement is published on the company's and HKEX websites, and the interim report will be dispatched to shareholders and published online as per Listing Rules - This interim results announcement is published on the company's website (www.pegbio.com) and the HKEX website (www.hkexnews.hk)[85](index=85&type=chunk) - The company's interim report for the six months ended June 30, 2025, will be dispatched in printed form to shareholders who have requested company communications and published on the company's and HKEX websites, respectively, in accordance with the Listing Rules[85] Consolidated Financial Statements Presents the company's consolidated financial statements, including the statement of profit or loss and other comprehensive income, and the statement of financial position Consolidated Statement of Profit or Loss and Other Comprehensive Income For the six months ended June 30, 2025, the company reported a loss for the period of RMB 93.672 million, a significant reduction from RMB 155.490 million in the prior year, primarily due to decreased R&D and administrative expenses Consolidated Statement of Profit or Loss and Other Comprehensive Income Summary | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Other Net Income | 178 | 4,053 | | Selling and Marketing Expenses | (4,765) | (3,009) | | Research and Development Expenses | (26,294) | (64,038) | | Administrative Expenses | (61,254) | (91,336) | | Operating Loss | (92,135) | (154,330) | | Finance Costs | (1,537) | (1,160) | | Loss Before Tax | (93,672) | (155,490) | | Income Tax | – | – | | Loss for the Period | (93,672) | (155,490) | | Total Comprehensive Income for the Period | (93,672) | (155,490) | | Loss per Share – Basic and Diluted (RMB) | (0.25) | (0.42) | Consolidated Statement of Financial Position As of June 30, 2025, total assets increased to RMB 383.347 million, and total equity significantly grew to RMB 260.449 million, with a notable improvement in net current assets, reflecting enhanced capital strength post-IPO Consolidated Statement of Financial Position Summary | Item | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Non-current Assets | 37,268 | 28,063 | | Current Assets | 346,079 | 190,294 | | Total Assets | 383,347 | 218,357 | | Current Liabilities | 112,535 | 157,666 | | Net Current Assets | 233,544 | 32,628 | | Non-current Liabilities | 10,363 | 3,221 | | Net Assets | 260,449 | 57,470 | | Total Equity Attributable to Equity Holders of the Company | 255,223 | 52,190 | | Non-controlling Interests | 5,226 | 5,280 | | Total Equity | 260,449 | 57,470 | Notes Provides detailed explanations and disclosures for the financial statements, covering accounting policies, specific financial items, and other relevant information 1 Basis of Preparation This interim financial report is prepared in accordance with HKEX Listing Rules and HKAS 34, reviewed by the Audit Committee, and authorized for publication, though it remains unaudited but reviewed by KPMG - This interim financial report is prepared in accordance with the applicable disclosure provisions of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited and Hong Kong Accounting Standard 34 Interim Financial Reporting issued by the Hong Kong Institute of Certified Public Accountants[89] - The report has been reviewed by the company's Audit Committee and was authorized for publication on August 26, 2025[89] - This interim financial report is unaudited, but KPMG has performed a review in accordance with Hong Kong Standard on Review Engagements 2410[90] 2 Changes in Accounting Policies The group applied HKAS 21 amendment "The Effects of Changes in Foreign Exchange Rates – Lack of Exchangeability," but it had no material impact on this interim report due to the absence of relevant foreign currency transactions - The Group has applied the amendment to Hong Kong Accounting Standard 21 "The Effects of Changes in Foreign Exchange Rates – Lack of Exchangeability" issued by the Hong Kong Institute of Certified Public Accountants for this accounting period[91] - As the Group did not engage in any foreign currency transactions where one foreign currency is not exchangeable into another, this amendment had no material impact on this interim report[91] 3 Other Net Income For the six months ended June 30, 2025, other net income was RMB 0.178 million, a significant decrease from RMB 4.053 million in the prior year, mainly due to reduced gains from financial instruments and government grants, and increased exchange losses Other Net Income Breakdown | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Realized and Unrealized Net Gains from Financial Instruments at Fair Value Through Profit or Loss | 1,523 | 3,280 | | Government Grants | 1 | 202 | | Bank Deposit Interest Income | 174 | 638 | | Exchange Losses | (1,532) | (3) | | Other | 12 | (64) | | Total | 178 | 4,053 | 4 Loss Before Tax Loss before tax is stated after deducting items such as finance costs, depreciation of property, plant and equipment, depreciation of right-of-use assets, amortization of intangible assets, and equity-settled share-based payment expenses Finance Costs Breakdown | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Interest on Interest-Bearing Borrowings | 1,391 | 1,093 | | Interest on Lease Liabilities | 146 | 67 | | Total | 1,537 | 1,160 | Other Items Breakdown | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Depreciation of Property, Plant and Equipment | 451 | 388 | | Depreciation of Right-of-Use Assets | 926 | 724 | | Amortization of Intangible Assets | 154 | 140 | | Equity-Settled Share-based Payment Expenses | 42,572 | 87,660 | 5 Income Tax The company's Chinese subsidiaries are subject to a 25% corporate income tax rate and benefit from a 100% super deduction for eligible R&D expenses; the group had no taxable profits for the six months ended June 30, 2025, and 2024 - The company's subsidiaries established and operating in China are subject to Chinese corporate income tax at a rate of 25%[96] - Under tax incentive policies, eligible R&D expenses are allowed a 100% super deduction from taxable income[96] - For the six months ended June 30, 2024, and 2025, the Group had no taxable profits[97] 6 Loss Per Share For the six months ended June 30, 2025, both basic and diluted loss per share were RMB 0.25, a reduction from RMB 0.42 in the prior year, primarily due to the decreased loss attributable to equity holders - For the six months ended June 30, 2025, the basic loss per share was RMB 0.25 (H1 2024: RMB 0.42)[98] - Diluted loss per share is the same as basic loss per share because the company has no outstanding ordinary shares or potential ordinary shares with a dilutive effect[99] 7 Right-of-Use Assets For the six months ended June 30, 2025, the company recognized new right-of-use assets of RMB 9.559 million, primarily for office building leases - For the six months ended June 30, 2025, the Group entered into lease agreements for the use of office buildings and recognized new right-of-use assets of RMB 9.559 million[100] 8 Prepayments and Other Receivables As of June 30, 2025, total prepayments and other receivables were RMB 13.297 million, an increase from RMB 8.247 million as of December 31, 2024, mainly due to increased prepayments to suppliers Prepayments and Other Receivables Breakdown | Item | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Prepayments to Suppliers | 9,312 | 2,886 | | Prepayments for Listing Expenses | – | 1,999 | | Other Receivables and Deposits | 3,985 | 3,362 | | Total | 13,297 | 8,247 | - All prepayments and other receivables are expected to be recovered or recognized as expenses within one year[101] 9 Financial Assets at Fair Value Through Profit or Loss As of June 30, 2025, total financial assets at fair value through profit or loss were RMB 68.185 million, a significant decrease from RMB 153.655 million as of December 31, 2024, primarily due to a reduction in transferable bank time deposits Financial Assets at Fair Value Through Profit or Loss Breakdown | Item | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Transferable Bank Time Deposits | 53,231 | 138,522 | | Wealth Management Products | 14,954 | 15,133 | | Total | 68,185 | 153,655 | - Transferable bank time deposits are primarily used for short-term cash management and will be sold in the secondary market within one year based on cash needs[102] 10 Trade and Other Payables As of June 30, 2025, total trade and other payables were RMB 35.872 million, a decrease from RMB 56.394 million as of December 31, 2024, mainly due to reduced trade payables and other payables Trade and Other Payables Breakdown | Item | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Trade Payables (within one year) | 26,640 | 34,933 | | Trade Payables (over one year) | 338 | 190 | | Accrued Staff Costs | 2,416 | 3,958 | | Taxes Payable | 312 | 429 | | Other Payables and Accrued Expenses | 6,166 | 16,884 | | Total | 35,872 | 56,394 | - All trade and other payables are expected to be settled or repaid on demand within one year[104] 11 Interest-Bearing Borrowings As of June 30, 2025, total interest-bearing borrowings were RMB 75.059 million, a decrease from RMB 100.003 million as of December 31, 2024; all borrowings are unsecured and due within one year Interest-Bearing Borrowings Breakdown | Item | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Bank Loans | 75,059 | 91,582 | | Letter of Credit Financing | – | 8,421 | | Total | 75,059 | 100,003 | - As of June 30, 2025, all the above interest-bearing borrowings are unsecured, accounted for at amortized cost, and will be settled within one year[105] 12 Capital, Reserves and Dividends The company completed its H-share listing in May 2025, issuing 19,284,000 new H-shares for gross proceeds of approximately RMB 275.924 million, with RMB 19.284 million credited to share capital and the premium to capital reserve; no dividends were proposed this period, and the RSU plan continues to incentivize employees (a) Share Capital and Capital Reserve In May 2025, the company issued 19,284,000 new H-shares at HK$15.60 each through an IPO on HKEX, generating gross proceeds of approximately RMB 275.924 million, with RMB 19.284 million credited to share capital and RMB 234.795 million to capital reserve - In May 2025, the company issued 19,284,000 new H-shares at a price of HK$15.60 per share through an initial public offering on The Stock Exchange of Hong Kong Limited[106] - The gross proceeds from the offering amounted to HK$300,823,000 (equivalent to approximately RMB 275.924 million), of which RMB 19.284 million was credited to share capital, and the corresponding premium of RMB 234.795 million was recognized in capital reserve[106] (b) Dividends For the six months ended June 30, 2025, the company's directors did not recommend the payment of any dividends - For the six months ended June 30, 2025, the company's directors did not recommend the payment of any dividends (for the six months ended June 30, 2024: nil)[107] (c) Equity-Settled Share-Based Transactions The company implements a Restricted Share Unit (RSU) scheme to incentivize employees, incorporating service and non-market performance conditions; for the six months ended June 30, 2025, equity-settled share-based payment expenses of RMB 42.572 million were recognized - The company has adopted a Restricted Share Unit (RSU) scheme to provide incentives to eligible employees of the Group, which includes certain service conditions and non-market performance conditions[108] - Certain terms and conditions of the scheme were revised in February 2024, changing the implicit service period to 12 months after the completion date of the initial public offering[108] Restricted Share Unit Movement | Item | 2025 (Number of Company's Shares) | 2024 (Number of Company's Shares) | | :--- | :--- | :--- | | Beginning of Period | 29,175,230 | 25,244,458 | | Granted | – | 11,356,166 | | Forfeited | – | (97,737) | | Cancelled | – | (7,327,657) | | End of Period | 29,175,230 | 29,175,230 | - The Group recognized equity-settled share-based payment expenses of RMB 42.572 million for the six months ended June 30, 2025[110] Definitions This section provides definitions for key terms and abbreviations used in the report to ensure a clear understanding of its content Glossary This section provides explanations for medical and biotechnology-related professional terms used in the report, including drug mechanisms of action, disease names, and clinical trial stages