百奥赛图(02315) - 2025 - 中期业绩

Financial Summary The company reported a significant increase in revenue and gross profit for the six months ended June 30, 2025, turning a loss into a profit before tax and for the period, with strong growth in net cash from operating activities Financial Summary for the Six Months Ended June 30, 2025 | Indicator | June 30, 2025 (RMB in thousands) | June 30, 2024 (RMB in thousands) | Year-on-year change | | :--- | :--- | :--- | :--- | | Revenue | 620,963 | 410,499 | 51.3% | | Gross Profit | 461,949 | 305,493 | 51.2% | | Profit/(Loss) Before Tax | 59,620 | (47,077) | N/A | | Profit/(Loss) for the Period | 47,999 | (50,673) | N/A | | Profit/(Loss) for the Period Attributable to Equity Holders of the Company | 47,999 | (50,673) | N/A | | Total Comprehensive Income for the Period | 47,961 | (50,901) | N/A | | Earnings/(Loss) Per Share, Basic and Diluted (RMB) | 0.12 | (0.13) | N/A | | Net Cash from Operating Activities | 203,434 | 29,608 | 587.1% | | Net Increase/(Decrease) in Cash and Cash Equivalents | 33,252 | (15,821) | N/A | Consolidated Financial Statements This section presents the company's consolidated financial performance and position for the reporting period, including statements of profit or loss, comprehensive income, and financial position Consolidated Statement of Profit or Loss and Other Comprehensive Income For the six months ended June 30, 2025, the company achieved revenue of RMB 620,963 thousand, a 51.3% year-on-year increase, successfully turning a loss into a profit of RMB 47,999 thousand for the period, compared to a loss of RMB 50,673 thousand in the prior year, with gross profit increasing 51.2% to RMB 461,949 thousand and operating profit significantly growing to RMB 107,402 thousand Key Data from Consolidated Statement of Profit or Loss and Other Comprehensive Income | Indicator | June 30, 2025 (RMB in thousands) | June 30, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Revenue | 620,963 | 410,499 | | Cost of Sales | (159,014) | (105,006) | | Gross Profit | 461,949 | 305,493 | | Other Income and Losses, Net | 8,512 | 9,529 | | Net Change in Fair Value of Biological Assets | 20,796 | 6,483 | | Selling and Marketing Expenses | (58,515) | (42,472) | | General and Administrative Expenses | (116,231) | (102,618) | | Research and Development Expenses | (209,109) | (161,679) | | Operating Profit | 107,402 | 14,736 | | Finance Costs | (35,926) | (52,728) | | Share of Loss of Associates | (11,856) | (9,085) | | Profit/(Loss) Before Tax | 59,620 | (47,077) | | Income Tax | (11,621) | (3,596) | | Profit/(Loss) for the Period | 47,999 | (50,673) | | Total Comprehensive Income for the Period | 47,961 | (50,901) | | Earnings/(Loss) Per Share, Basic and Diluted (RMB) | 0.12 | (0.13) | Consolidated Statement of Financial Position As of June 30, 2025, the company's total assets less current liabilities amounted to RMB 2,016,749 thousand, an increase from December 31, 2024, with net current assets significantly rising to RMB 418,607 thousand primarily due to increased bank and cash balances, and total equity growing to RMB 896,584 thousand Key Data from Consolidated Statement of Financial Position | Indicator | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Non-current Assets | | | | Property, Plant and Equipment | 1,353,378 | 1,349,489 | | Intangible Assets | 16,979 | 20,665 | | Interests in Associates | 147,893 | 159,038 | | Other Non-current Assets | 79,352 | 68,630 | | Deferred Tax Assets | 540 | 957 | | Current Assets | | | | Inventories | 5,899 | 3,890 | | Contract Costs | 41,703 | 49,654 | | Biological Assets | 121,271 | 99,667 | | Trade and Bills Receivables | 201,083 | 229,608 | | Prepayments and Other Receivables | 40,339 | 29,866 | | Bank and Cash Balances | 479,572 | 403,850 | | Current Liabilities | | | | Trade and Bills Payables | 104,620 | 115,479 | | Contract Liabilities | 109,075 | 102,188 | | Other Payables | 73,037 | 87,237 | | Bank and Other Borrowings | 153,802 | 208,138 | | Lease Liabilities | 30,726 | 17,857 | | Current Tax | – | 4,014 | | Non-current Liabilities | | | | Deferred Revenue | 83,967 | 84,902 | | Lease Liabilities | 181,636 | 150,447 | | Long-term Payables | 606,548 | 612,616 | | Bank and Other Borrowings | 248,014 | 193,835 | | Equity | | | | Share Capital | 399,398 | 399,398 | | Reserves | 492,641 | 434,658 | | Total Equity Attributable to Equity Holders of the Company | 892,039 | 834,056 | | Non-controlling Interests | 4,545 | 4,545 | | Total Equity | 896,584 | 838,601 | Notes to the Financial Statements This section provides detailed explanations and disclosures regarding the company's accounting policies, revenue breakdown, segment information, and other financial items supporting the consolidated financial statements General Information Biocytogen Pharmaceuticals (Beijing) Co., Ltd. was established in 2009, restructured into a joint-stock company in 2020, and listed on the Hong Kong Stock Exchange in 2022, with its group primarily engaged in gene editing services, preclinical pharmacological efficacy evaluation, model animal sales, antibody development, and innovative biopharmaceutical research and development - The company was incorporated in China on November 13, 2009, restructured into a joint-stock company on December 29, 2020, and listed on the Main Board of the Hong Kong Stock Exchange on September 1, 2022[8] - The Group's principal activities include gene editing services, preclinical pharmacological efficacy evaluation services, model animal sales, antibody development, and innovative biopharmaceutical research and development[8] Basis of Preparation This interim financial report is prepared in accordance with the Hong Kong Stock Exchange Listing Rules and International Accounting Standard 34, authorized for issue on August 28, 2025, and has been reviewed by KPMG in accordance with Hong Kong Standard on Review Engagements 2410, though it remains unaudited - This interim financial report is prepared in accordance with the Listing Rules of the Hong Kong Stock Exchange and International Accounting Standard 34 "Interim Financial Reporting"[9] - The report is unaudited but has been reviewed by KPMG in accordance with Hong Kong Standard on Review Engagements 2410[9] Changes in Accounting Policies The Group has applied HKAS 21 (Amendment) – The Effects of Changes in Foreign Exchange Rates – Lack of Exchangeability, which has no material impact on this interim report due to the absence of relevant foreign currency transactions, and no new standards or interpretations not yet effective have been applied in this accounting period - The Group has applied HKAS 21 (Amendment) – The Effects of Changes in Foreign Exchange Rates – Lack of Exchangeability, but it has no material impact on this interim report[10] - No new standards or interpretations not yet effective have been applied in this accounting period[11] Revenue and Segment Reporting The Group's revenue primarily stems from gene editing, preclinical pharmacological efficacy evaluation, model animal sales, and antibody development services, totaling RMB 620,963 thousand for the six months ended June 30, 2025, with model animal sales contributing the most, followed by antibody development and preclinical pharmacological efficacy evaluation, and the US being the largest overseas market - The Group currently has no products approved for commercial sale and has not generated any revenue from the sale of innovative drugs[12] Revenue For the six months ended June 30, 2025, the Group's total revenue was RMB 620,963 thousand, with model animal sales contributing RMB 274,426 thousand, antibody development RMB 162,863 thousand, and preclinical pharmacological efficacy evaluation RMB 155,031 thousand, and one customer's transactions accounted for over 10% of total revenue Revenue from Contracts with Customers by Major Service Line | Service Line | 2025 (RMB in thousands) | 2024 (RMB in thousands) | | :--- | :--- | :--- | | Gene Editing | 28,617 | 34,606 | | Preclinical Pharmacological Efficacy Evaluation | 155,031 | 81,552 | | Model Animal Sales | 274,426 | 175,772 | | Antibody Development | 162,863 | 118,200 | | Others | 26 | 369 | | Total | 620,963 | 410,499 | - For the six months ended June 30, 2025, transactions with one customer accounted for over 10% of the Group's revenue, totaling RMB 88,483,000[13] Segment Reporting The Group manages its business across five reportable segments: gene editing services, preclinical pharmacological efficacy evaluation, model animal sales, antibody development, and innovative drug development, with total reportable segment gross profit amounting to RMB 465,394 thousand in the first half of 2025, measured by gross profit - The Group has five reportable segments: gene editing services, preclinical pharmacological efficacy evaluation, model animal sales, antibody development, and innovative drug development[13][14] - Segment results are measured by gross profit, while other operating income and expenses, assets, and liabilities are not measured by individual segments[15] Revenue and Gross Profit by Reportable Segment (For the six months ended June 30, 2025) | Segment | Revenue from External Customers (RMB in thousands) | Reportable Segment Gross Profit (RMB in thousands) | | :--- | :--- | :--- | | Gene Editing | 28,617 | 16,693 | | Preclinical Pharmacological Efficacy Evaluation | 155,031 | 77,298 | | Model Animal Sales | 274,426 | 228,063 | | Antibody Development | 162,863 | 143,314 | | Innovative Drug Development | – | – | | Others | 26 | 26 | | Total | 620,963 | 465,394 | Reconciliation of Reportable Segment Gross Profit | Indicator | 2025 (RMB in thousands) | 2024 (RMB in thousands) | | :--- | :--- | :--- | | Reportable Segment Gross Profit | 465,394 | 306,730 | | Elimination of Inter-segment Gross Profit | (3,445) | (1,237) | | Consolidated Gross Profit | 461,949 | 305,493 | Geographical Information The Group's revenue from external customers primarily originates from China and the United States, with the US contributing RMB 322,697 thousand and China RMB 199,474 thousand for the six months ended June 30, 2025, while non-current assets are mainly located in China Geographical Information of Revenue from External Customers | Region | 2025 (RMB in thousands) | 2024 (RMB in thousands) | | :--- | :--- | :--- | | China | 199,474 | 116,968 | | United States of America ("US") | 322,697 | 218,444 | | Others | 98,792 | 75,087 | | Total | 620,963 | 410,499 | Geographical Location of Specific Non-current Assets | Region | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | China | 1,199,250 | 1,189,091 | | US | 170,744 | 181,025 | | Others | 363 | 38 | | Total | 1,370,357 | 1,370,154 | Other Income and Losses, Net For the six months ended June 30, 2025, other income and losses, net, totaled approximately RMB 8.5 million, a 10.5% decrease from the prior year, primarily due to reduced interest income and net exchange gains Details of Other Income and Losses, Net | Item | 2025 (RMB in thousands) | 2024 (RMB in thousands) | | :--- | :--- | :--- | | Net Gain on Disposal of Property, Plant and Equipment | 920 | – | | Fair Value Changes of Financial Assets at Fair Value Through Profit or Loss | 2,209 | (901) | | Interest Income | 2,360 | 3,448 | | Government Grants (including amortization of deferred income) | 2,442 | 2,333 | | Net Exchange Gain | 581 | 4,649 | | Total | 8,512 | 9,529 | - Other income and losses, net, decreased by 10.5%, primarily due to reduced interest income and net exchange gains[110] Net Change in Fair Value of Biological Assets For the six months ended June 30, 2025, the net change in fair value of biological assets significantly increased by 220.0% to approximately RMB 20.8 million, mainly due to higher inventory levels of humanized mice, with the fair value change comprising realized negative and unrealized positive changes - The net change in fair value of biological assets increased by 220.0% from approximately RMB 6.5 million in the prior year to approximately RMB 20.8 million for the six months ended June 30, 2025[111] - The increase is primarily attributable to a higher inventory level of humanized mice for the six months ended June 30, 2025, compared to the prior year[111] - The net change in fair value includes a realized negative fair value change of RMB 79,015,000 and an unrealized positive fair value change of RMB 99,811,000[21] Profit/(Loss) Before Tax The profit/(loss) before tax is calculated after deducting finance costs, staff costs, and other items; for the six months ended June 30, 2025, finance costs decreased by 31.9%, staff costs increased due to higher salaries and share-based payment expenses, while depreciation expenses remained stable Finance Costs For the six months ended June 30, 2025, finance costs amounted to RMB 35,926 thousand, a 31.9% decrease from RMB 52,728 thousand in the prior year, primarily due to reduced interest on long-term payables Details of Finance Costs | Item | 2025 (RMB in thousands) | 2024 (RMB in thousands) | | :--- | :--- | :--- | | Interest on Long-term Payables | 21,711 | 36,797 | | Interest on Lease Liabilities | 6,661 | 7,143 | | Interest on Bank and Other Borrowings | 7,554 | 8,788 | | Total | 35,926 | 52,728 | - Finance costs decreased by 31.9%, primarily due to reduced interest on long-term payables[116] Staff Costs For the six months ended June 30, 2025, staff costs increased significantly to RMB 222,121 thousand from RMB 152,229 thousand in the prior year, mainly due to higher salaries, wages, other benefits, and equity-settled share-based payment expenses Details of Staff Costs | Item | 2025 (RMB in thousands) | 2024 (RMB in thousands) | | :--- | :--- | :--- | | Salaries, Wages and Other Benefits | 187,672 | 133,097 | | Contributions to Defined Contribution Retirement Plans | 15,137 | 14,044 | | Equity-settled Share-based Payment Expenses | 19,312 | 5,088 | | Total | 222,121 | 152,229 | - The company and its PRC subsidiaries participate in defined contribution retirement plans for employees, while its US subsidiary implements a 401(k) savings plan with matching contributions for US employees[23] Other Items For the six months ended June 30, 2025, depreciation of property, plant and equipment was RMB 81,363 thousand, remaining largely consistent with the prior year, while impairment loss recognized on trade and other receivables decreased Details of Other Items | Item | 2025 (RMB in thousands) | 2024 (RMB in thousands) | | :--- | :--- | :--- | | Depreciation of Property, Plant and Equipment | 81,363 | 81,573 | | Amortization of Intangible Assets | 3,736 | 3,888 | | Impairment Loss Recognized on Trade and Other Receivables | 2,260 | 3,795 | | Provision for Write-down of Inventories and Contract Costs | 5,884 | 5,442 | | Cost of Inventories | 84,193 | 50,144 | Income Tax in Consolidated Statement of Profit or Loss For the six months ended June 30, 2025, income tax expense increased to RMB 11,621 thousand, primarily due to higher foreign withholding tax, which mainly applies to antibody licensing income generated in the US, South Korea, and other countries Details of Income Tax in Consolidated Statement of Profit or Loss | Item | 2025 (RMB in thousands) | 2024 (RMB in thousands) | | :--- | :--- | :--- | | Current Tax - Provision for Income Tax for the Period | 1,397 | 381 | | Current Tax - Foreign Withholding Tax | 9,810 | 3,716 | | Deferred Tax - Temporary Differences Arising and Reversing | 414 | (501) | | Total | 11,621 | 3,596 | - Foreign withholding tax primarily applies to the Group's antibody licensing income generated in the US, South Korea, and certain other countries[26] Earnings/(Loss) Per Share For the six months ended June 30, 2025, the company achieved basic earnings per share of RMB 0.12, a significant improvement from a loss of RMB 0.13 per share in the prior year, with no diluted earnings per share presented due to the absence of potential dilutive ordinary shares during the reporting period Basic Earnings/(Loss) Per Share For the six months ended June 30, 2025, basic earnings per share were RMB 0.12, calculated based on profit attributable to equity holders of the company of RMB 47,999 thousand and a weighted average of 396,257 thousand ordinary shares - For the six months ended June 30, 2025, basic earnings per share were RMB 0.12, compared to a loss of RMB 0.13 per share in the prior year[27] - The calculation is based on profit attributable to ordinary equity holders of the company of RMB 47,999 thousand and a weighted average of 396,257 thousand ordinary shares outstanding[27] Diluted Earnings Per Share Diluted earnings per share are not presented for the six months ended June 30, 2025, and 2024, as there were no potential dilutive ordinary shares during these periods - Diluted earnings per share are not presented for the six months ended June 30, 2025, and 2024, as there were no potential dilutive ordinary shares during these periods[28] Trade and Bills Receivables As of June 30, 2025, total trade and bills receivables amounted to RMB 201,083 thousand, a decrease from RMB 229,608 thousand as of December 31, 2024, primarily due to a significant reduction in trade receivables from related parties Details of Trade and Bills Receivables | Item | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Trade Receivables - Third Parties | 223,410 | 209,899 | | Trade Receivables - Related Parties | 134 | 40,441 | | Less: Loss Allowance | (22,496) | (20,892) | | Bills Receivable | 35 | 160 | | Total | 201,083 | 229,608 | Ageing Analysis of Trade Receivables The Group generally offers credit terms of 0 to 90 days, with trade receivables within 1 year amounting to RMB 185,609 thousand as of June 30, 2025, constituting the majority of the total Ageing Analysis of Trade Receivables | Ageing | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Within 1 year | 185,609 | 211,549 | | 1 to 2 years | 9,490 | 12,039 | | 2 to 3 years | 5,949 | 5,860 | | Total | 201,048 | 229,448 | - The Group generally offers credit terms of 0 to 90 days to its trade customers[30] Trade and Bills Payables As of June 30, 2025, total trade and bills payables amounted to RMB 104,620 thousand, a decrease from RMB 115,479 thousand as of December 31, 2024 Details of Trade and Bills Payables | Item | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Trade Payables - Third Parties | 74,519 | 69,663 | | Bills Payable | 30,101 | 45,816 | | Total | 104,620 | 115,479 | Ageing Analysis As of June 30, 2025, trade payables within 1 year amounted to RMB 95,158 thousand, representing the vast majority of the total Ageing Analysis of Trade Payables | Ageing | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Within 1 year | 95,158 | 106,118 | | 1 to 2 years | 5,695 | 7,358 | | 2 to 3 years | 3,009 | 1,532 | | Over 3 years | 758 | 471 | | Total | 104,620 | 115,479 | Capital, Reserves and Dividends For the six months ended June 30, 2025, the company did not declare or pay dividends, and the number of unexercised shares held by the trustee under the 2022 Share Award Scheme increased as of the end of the reporting period Dividends For the six months ended June 30, 2025, the company did not declare or pay any interim dividends - For the six months ended June 30, 2025, the company did not declare or pay any dividends (for the six months ended June 30, 2024: nil)[33] Treasury Shares (Shares Held for Share Award Scheme) The company has a 2022 Share Award Scheme, with the trustee holding shares to administer the plan; as of June 30, 2025, the trustee held 3,266,607 unexercised shares at a total cost of RMB 40,181 thousand - The company approved the 2022 Share Award Scheme on October 17, 2022, valid until November 7, 2032[34] - As of June 30, 2025, the trustee held 3,266,607 shares (December 31, 2024: 2,509,644 shares) for the 2022 Share Award Scheme, with a total cost of RMB 40,181 thousand[34] - For the six months ended June 30, 2025, a total of 199,037 shares were unlocked and transferred to employees[34] Management Discussion and Analysis This section provides a comprehensive review of the company's business operations, financial performance, and strategic outlook for the reporting period I. Business Review Biocytogen is a global biotechnology company focused on novel antibody drug research and development and preclinical research services, achieving strong performance in the first half of 2025 with a 51.3% year-on-year increase in operating revenue to RMB 621.0 million, a turnaround to net profit exceeding last year's full-year level, and positive net cash flow for the first time, signaling entry into a virtuous cycle of endogenous growth - The company is headquartered in Beijing, with branches in China, the US, and Germany, dedicated to novel antibody drug research and development and preclinical research services[35] - In the first half of 2025, operating revenue reached RMB 621.0 million, a 51.3% year-on-year increase; net profit was RMB 48.0 million, turning a loss into profit and exceeding last year's full-year level[36] - Net cash inflow from operating activities was RMB 203.4 million, and net cash flow was RMB 33.3 million, with overall cash flow turning positive, marking the company's entry into a virtuous cycle of endogenous growth[36] Overview The company has established a "dual-driven" business ecosystem of preclinical products and services and antibody discovery, both achieving high growth, with preclinical products and services revenue reaching RMB 458.1 million (56.9% growth) and antibody discovery revenue RMB 162.9 million (37.8% growth), while maintaining high R&D investment and actively expanding into overseas markets for a global footprint - The company has established a "dual-driven" business ecosystem of preclinical products and services and antibody discovery, achieving bidirectional empowerment through technological synergy and resource linkage[37] - Preclinical products and services business achieved operating revenue of RMB 458.1 million, a 56.9% year-on-year increase, with a gross margin of approximately 70%[37] - Antibody discovery business achieved operating revenue of RMB 162.9 million, a 37.8% year-on-year increase, with a gross margin of approximately 90%[38] - As of June 30, 2025, approximately 280 therapeutic antibody and various clinical asset co-development/licensing/transfer agreements have been signed, with approximately 80 new agreements signed in the first half of 2025, a year-on-year increase of approximately 60%[38] - Overseas business achieved operating revenue of RMB 421.5 million, and domestic business achieved operating revenue of RMB 199.5 million, with global presence enhancing business resilience[38] - R&D expenses for the first half of 2025 were RMB 209.1 million, an increase of RMB 47.4 million from the prior year, with an R&D expense ratio exceeding 30%[39] - The company completed the initial R&D work for Project Integrum (Thousand-Mouse-Antibody Project) by the end of Q3 2023 and has built a vast antibody sequence library, with approximately 280 co-development/licensed-out/transferred development agreements reached as of June 30, 2025[42] - The company currently has no plans to invest its own resources to lead the continued development of pipeline drug candidates, opting instead to entrust partners to advance late-stage clinical development and future commercialization[43] Self-developed Products The company possesses multiple clinical and preclinical stage self-developed antibody drug pipelines, including core products YH001 and YH003, as well as several bispecific antibodies and ADC drugs co-developed with partners, primarily focusing on oncology and autoimmune disease treatments, and accelerating development through external licensing collaborations Product Pipeline and Development Status | Pipeline Project | Target | Indication | Preclinical | Phase I | Phase II | Phase III | Collaborator | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | YH001 | CTLA-4 | Oncology | | ● | | | Syncromune, Inc. | | YH002 | OX40 | Oncology | | ● | | | Syncromune, Inc. | | YH003 | CD40 | Oncology | | ● | ● | | Syncromune, Inc. | | YH004 | 4-1BB | Oncology | | ● | | | | | YH008 | PD-1 x CD40 Bispecific Antibody | Oncology | | ● | | | RemeGen Co., Ltd. | | YH013 | EGFR x MET Bispecific ADC | Oncology | ● | | | | Doma | | YH012 | HER2 x TROP2 Bispecific ADC | Oncology | ● | | | | Licensed Out/Collaboration | | YH015 | CD40 Inhibitor | Immunological Diseases | ● | | | | | | YH016 | Undisclosed | Oncology | ● | | | | Licensed Out/Collaboration | | YH017 | Undisclosed | Immunological Diseases | ● | | | | Licensed Out/Collaboration | Core Products YH001 and YH003 are the company's core products; YH001, a humanized anti-CTLA-4 IgG1 monoclonal antibody, has completed Phase I clinical trials and is being co-developed with Syncromune for intratumoral injection products, while YH003, a humanized IgG2 agonistic monoclonal antibody targeting CD40, has completed multiple Phase I/II clinical trials and is also in collaboration with Syncromune - YH001 has completed Phase I clinical trials in Australia and Phase I clinical trials as a monotherapy for advanced solid tumors in China, showing good tolerability and anti-tumor activity[49] - The company signed a licensing agreement with Syncromune to develop intratumoral injection products using YH001, YH002, and YH003 as active ingredients via Syncrovax™ technology, with SYNC-T SV-102 therapy receiving US FDA Fast Track designation[50] - YH003 has completed multiple Phase I/II clinical trials in Australia, the US, mainland China, and other regions, evaluating its safety and efficacy in combination with toripalimab for advanced solid tumors and pancreatic ductal adenocarcinoma, demonstrating good safety and tolerability, and achieving promising clinical efficacy[52] Other Products The company also has several other pipeline products, including YH002 (anti-OX40 mAb), YH004 (anti-4-1BB agonist), YH005 (anti-Claudin 18.2 ADC with RemeGen), YH008 (PD-1 x CD40 bispecific antibody with Chipscreen Biosciences), YH012 (HER2/TROP2 bispecific ADC), YH013 (EGFR/MET bispecific ADC), YH015 (CD40 inhibitor), and novel molecules YH016 and YH017, with many having external collaborations or licensing agreements - YH002, an anti-OX40 monoclonal antibody, has completed a Phase I dose-escalation study in Australia, demonstrating good safety and tolerability[53] - YH004, a humanized anti-4-1BB agonist, has completed a Phase I study in China, with the company seeking partners for further development[55] - YH005 (RC118) has been licensed to RemeGen for development, received two US FDA Orphan Drug Designations, and was approved by the CDE for Phase I/IIa clinical studies[56] - YH008 bispecific antibody has been exclusively licensed to Chipscreen Biosciences for development and commercialization in Greater China, with Phase I patient enrollment commencing in January 2024[57] - YH012 (HER2/TROP2 bispecific ADC) and YH013 (EGFR/MET bispecific ADC) are bispecific ADCs developed based on the RenLite platform, with option and licensing agreements reached with external collaborators[59][60] - YH015, a fully human IgG1 antagonistic monoclonal antibody targeting CD40, is currently in the CMC stage, with the company seeking partners for future development[61] - YH016 (oncology) and YH017 (immunological diseases) are novel fully human antibody molecules developed using the RenMice® platform, with option and licensing agreements reached with various partners[62] Preclinical Research Services and Products The Group's preclinical research services and products include model animal sales, preclinical pharmacological efficacy evaluation, and custom gene editing services, with the company continuously expanding model animal categories, growing its overseas sales team, and enlarging its Boston, US, experimental base, achieving significant sales growth and high gross margins - Preclinical research services and products represent a significant business segment for the company, providing operating cash flow through rapid sales growth and high-profit margins[64] - The company has expanded its overseas sales team and enlarged its Boston, US, experimental base, achieving significant sales growth during the reporting period[64] Model Animal Sales Leveraging gene editing technology, the company has created a comprehensive range of antibody discovery and disease mouse models, including approximately 4,390 unique gene-edited mouse/cell line projects, launching hundreds of new model animals annually, primarily focused on oncology and autoimmune diseases, while actively exploring neurological, cardiovascular, and metabolic disease areas - The company has created a comprehensive range of antibody discovery and disease mouse models, including approximately 4,390 unique gene-edited mouse/cell line projects[65] - Hundreds of new model animals are continuously launched to the market annually, while expanding domestic and international customer bases[65] - Current model animal disease types primarily focus on oncology and autoimmune diseases, with active expansion into neurological, cardiovascular, and metabolic disease areas[66] Humanized Mice The company has developed a series of immune checkpoint and cytokine humanized mice to address species differences, enabling human antibody drugs to elicit normal pharmacological responses in mice, thereby providing effective models for drug validation - The company has developed a series of immune checkpoint and other humanized mice based on the C57BL/6 genetic background, ensuring fully humanized mouse models[67] - By humanizing key cytokines or cytokine receptors in mice, the efficacy and pharmacological effects of human cytokine or cytokine receptor antibody drugs can be evaluated in mice[68] Severely Immunodeficient (B-NDG) Mice The company's independently developed B-NDG mice exhibit severe immunodeficiency, lacking mature T, B, and NK cells, making them ideal drug development vehicles for human hematopoietic stem cell, human peripheral blood mononuclear cell, human tumor cell, or tissue transplantation - B-NDG mice exhibit severe immunodeficiency, lacking mature T, B, and NK cells, making them ideal drug development vehicles for human hematopoietic stem cell, human peripheral blood mononuclear cell, human tumor cell, or tissue transplantation[69] - The company typically enters into framework agreements with customers for one to five years and accepts customer work orders under these agreements[69] Human Immune System Reconstitution Models Based on B-NDG mice, the company has developed a series of second-generation products, such as B-NDG B2m KO plus mice and B-NDG hIL15 mice, to address issues like hematopoietic cell differentiation maintenance and restricted immune cell development in severely immunodeficient mice, meeting diverse research needs - The company has developed a series of second-generation products based on B-NDG mice to address issues such as hematopoietic cell differentiation maintenance and restricted immune cell development in severely immunodeficient mice[70] - For example, B-NDG B2m KO plus mice can delay GVHD effects in PBMC reconstitution models, and B-NDG hIL15 mice can better promote human NK cell immune reconstitution[70] Preclinical Pharmacological Efficacy Evaluation The company provides comprehensive preclinical pharmacology services, including in vivo efficacy, PK/PD, biomarker evaluation, toxicology and safety assessment, and in vitro immune cell and cytokine analysis, having completed over 6,350 drug evaluation projects for approximately 950 global partners as of June 30, 2025 - The company's pharmacology team has accumulated expertise in testing new therapies, supporting global drug R&D, utilizing a large number of gene humanized mouse models and severely immunodeficient B-NDG mice[71] - Services include in vivo efficacy, PK/PD, biomarker evaluation, toxicology and safety assessment, and in vitro immune cell and cytokine analysis[71] - As of June 30, 2025, over 6,350 drug evaluation projects have been completed for approximately 950 global partners[71] In Vivo Pharmacology Capabilities The in vivo pharmacology team has successfully developed and validated hundreds of syngeneic and allogeneic tumor models, covering a wide range of immunotherapy areas, and has expanded research and services to include immune and autoimmune diseases, CNS, ophthalmology, metabolic, and kidney disease models - The in vivo pharmacology team has successfully developed and validated hundreds of syngeneic and allogeneic tumor models, covering a wide range of immunotherapy areas[73] - Services have expanded to include immune and autoimmune diseases, CNS diseases, ophthalmological diseases, metabolic disease models, and kidney disease models[73] Pharmacokinetics (PK) and Pharmacodynamics (PD) The company has established a comprehensive PK/PD service platform, utilizing target humanized mice and FcRn humanized mice to conduct a range of PK/PD studies, characterizing drug exposure, predicting dose requirements, understanding concentration-effect relationships, and supporting drug development and clinical trials - The company has established a comprehensive PK/PD service platform, utilizing target humanized mice and FcRn humanized mice to address the issue of human antibody PK parameters being unsuitable in animal species[75] - PK/PD evaluation is also supported by in vitro capabilities, including cell-based assays such as ADCC and CDC[75] Small Animal Toxicology and Safety Studies The company has established a toxicology and safety assessment platform using humanized mice and highly immunodeficient B-NDG mice, providing comprehensive toxicology and safety readouts to support predictive data for drug candidate evaluation and guide clinical study design - The company has established a toxicology and safety assessment platform using humanized mice and highly immunodeficient B-NDG mice[76] - Comprehensive toxicology and safety readouts include blood biochemical liver and kidney function assessment, histopathological assessment, cytokine release syndrome (CRS) assessment, anti-drug antibody (ADA) testing, and more[76] Gene Editing Gene editing technology is the cornerstone of the company's antibody R&D platform, utilizing advanced techniques to develop the transgenic RenMice® platform and Project Integrum (Thousand-Mouse-Antibody Project); the company offers custom gene editing services based on animal and cell lines, having completed approximately 5,300 custom projects and internally developed about 4,390 model products - Gene editing technology lays a solid foundation for the antibody R&D platform, utilizing advanced techniques to propose Project Integrum (Thousand-Mouse-Antibody Project) and develop the transgenic RenMice® platform[77][79] - The company provides custom gene editing services based on rat/mouse and cell lines, having completed approximately 5,300 custom gene editing projects and internally developed approximately 4,390 gene-edited animal and cell model products[79][80] Our Gene Editing Technologies The company has developed robust gene editing platforms, SUPCE, CRISPR/EGE, and ESC/HR, which drive technological innovation and have been successfully applied in the development of the RenMice® platform - The company has developed robust gene editing platforms, SUPCE, CRISPR/EGE, and ESC/HR, which are drivers of technological innovation[79] Custom Services The company primarily offers custom gene editing services based on rat/mouse and cell lines, with the final products being animal or cell line models with specific genotypes, covering various rat/mouse strains and cell lines, and providing supporting experimental services - The company primarily offers custom gene editing services based on rat/mouse and cell lines, with the final products being animal or cell line models with specific genotypes[80] - Mouse strains for gene editing services primarily include C57BL/6, BALB/c, DBA2, and NOD-scid, while rat strains primarily include Sprague Dawley and Wistar[80] RenMice® Platform for Generating Rich Fully Human Antibody Libraries The RenMice® platform is the company's core technology for generating rich fully human monoclonal and bispecific antibody libraries, including RenMab, RenLite, and RenNano, as well as RenTCRm and GPCR platforms, having secured multiple patents and entered into licensing and trial collaboration agreements with dozens of renowned multinational pharmaceutical companies - The RenMice® platform consists of several different chromosome-engineered mice with fully human immunoglobulin variable regions, including RenMab, RenLite, and RenNano[82] - As of June 30, 2025, licensing and trial collaboration agreements have been reached with dozens of renowned multinational pharmaceutical companies and leading pharmaceutical companies[83] - The RenMab platform obtained Chinese and US patents in 2023, and a Japanese patent in 2025[85] - The RenLite platform obtained US patent authorization in 2024, with its single fixed human common kappa light chain design addressing the light chain mismatch issue in bispecific antibodies[86] - The RenNano platform utilizes RenNano mice to produce heavy chain antibodies, whose generated fully human single-chain antibody fragment sequences do not require in vitro humanization modification[87] - The RenTCRm platform, based on HLA/RenMab, aims to break through the limitations of traditional antibody therapy, precisely identifying intracellular MAP epitopes and producing fully human antibodies against intracellular antigens[88] - The GPCR platform, developed based on RenMice®, addresses the challenges of obtaining GPCR and transmembrane protein antibodies through DNA immunization and target knockout RenMice (RenMice KO)[89] Marketing and Business Development The company acquires business through its marketing and business development teams and customer referrals, establishing a sales system covering Asia-Pacific, North America, and Europe, actively expanding overseas markets, enlarging its Boston R&D and production facilities, and maintaining long-term business collaborations with all top ten overseas pharmaceutical companies - The company has established a sales system covering Asia-Pacific, North America, and Europe, continuously expanding overseas markets and maintaining rapid growth in overseas sales revenue[90] - The company is expanding its R&D and production facilities in Boston and growing its Boston subsidiary's R&D and production team to provide localized services[90] - Since 2022, the company has optimized and upgraded its North American and European sales networks, establishing a subsidiary in Heidelberg, Germany, and offices in San Francisco and San Diego, US[91] - The antibody development business has maintained rapid growth since 2020, with its customer base expanding from well-known domestic biotechnology companies to globally renowned pharmaceutical companies[91] Production The company has established model animal production centers, encompassing approximately 55,000 square meters of animal facilities, offering significant cost advantages, and collaborates with CROs and CDMOs to support asset product R&D and clinical trials - The company has established model animal production centers, including three animal bases, covering approximately 55,000 square meters of animal facilities, offering significant cost advantages[94] - The company collaborates with CROs and CDMOs to conduct and support asset product R&D and clinical trials[95] Proposed A Share Issuance The company proposed an A share issuance and listing on the Shanghai Stock Exchange STAR Market in March 2023, having submitted application materials and received an acceptance letter, and is currently awaiting approval from the China Securities Regulatory Commission and the Shanghai Stock Exchange - The company proposed an A share issuance and listing on the Shanghai Stock Exchange STAR Market in March 2023, having submitted application materials and received an acceptance letter[96] - The A share issuance is subject to approval by the China Securities Regulatory Commission and the Shanghai Stock Exchange[96] Quality Management The company has a quality management department that has established a quality control system referencing ISO9001, GMP, and GLP standards, emphasizing quality control in the design, R&D, manufacturing, testing, and transportation of products and candidate products, with approximately 49 employees in the department as of June 30, 2025 - The company has established a quality control system referencing ISO9001, GMP, and GLP standards, emphasizing quality control in the design, R&D, manufacturing, testing, and transportation of products and candidate products[97] - As of June 30, 2025, the quality management department consists of approximately 49 employees, possessing extensive experience in quality management and drug registration[97] Suppliers The company has established policies to standardize supplier selection processes, conducting due diligence and regular evaluations to ensure supplier and product quality; as of June 30, 2025, the Group had approximately 2,300 suppliers, with over 2,200 from China - The company has formulated a series of policies to provide institutional guarantees for supplier access, selection, approval, monitoring, and evaluation[98] - As of June 30, 2025, the Group had approximately 2,300 suppliers, with over 2,200 from China[99] - The company collaborates with CROs and CDMOs to support asset product R&D and clinical trials, with core product R&D expenses for CROs and CDMOs amounting to approximately RMB 0.9 million for the six months ended June 30, 2025[100] Intellectual Property Intellectual property is crucial to the company's business; as of June 30, 2025, the company owned 301 registered trademarks, 195 granted patents, and 4 software copyrights, and had filed 496 patent applications in 27 countries or regions - As of June 30, 2025, the company owned 301 registered trademarks, 195 granted patents, and 4 software copyrights[101] - The company has filed 496 patent applications in 27 countries or regions, and has been granted 16 patents and filed 21 patent applications related to its core products[101] Future and Outlook The company will continue to adhere to its strategic goal of "innovation-driven new drug R&D," focusing on innovative animal models and antibody discovery, increasing R&D investment, and gradually building an "antibody evolution tree" encompassing over 1,000 targets and 1,000,000 fully human antibody molecules, while also developing an AI intelligent agent for antibody drug R&D to achieve scaled profitability - In the second half of 2025, the company will continue to adhere to its strategic goal of "innovation-driven new drug R&D," ensuring sufficient R&D investment, controlling expenses, improving operational efficiency, and moving towards the goal of achieving scaled profitability in 2025[102] - The company will continuously enrich the RenMice® platform, expand the Project Integrum (Thousand-Mouse-Antibody Project) fully human antibody sequence library, and focus on developing innovative animal models for more disease areas[103] - The company will gradually establish an "antibody evolution tree" encompassing over 1,000 targets and 1,000,000 fully human antibody molecules, and build an AI intelligent agent for antibody drug R&D through localized AI deployment[103] - The company will continue to expand global market development, improve its global R&D, production, and sales layout, and further optimize its global operating structure to enhance operational efficiency[104] II. Financial Review This section provides a detailed review of the financial performance for the six months ended June 30, 2025, including key financial indicators such as revenue, costs, profitability, liquidity, and capital resources, highlighting significant revenue growth, a turnaround to profit, strong operating cash flow, and continued R&D investment and global expansion Financial Overview for the Six Months Ended June 30, 2025 | Indicator | 2025 (RMB in thousands) | 2024 (RMB in thousands) | | :--- | :--- | :--- | | Revenue | 620,963 | 410,499 | | Cost of Sales | (159,014) | (105,006) | | Gross Profit | 461,949 | 305,493 | | Other Income and Losses, Net | 8,512 | 9,529 | | Net Change in Fair Value of Biological Assets | 20,796 | 6,483 | | Selling and Marketing Expenses | (58,515) | (42,472) | | General and Administrative Expenses | (116,231) | (102,618) | | Research and Development Expenses | (209,109) | (161,679) | | Profit/(Loss) Before Tax | 59,620 | (47,077) | | Profit/(Loss) for the Period | 47,999 | (50,673) | | Total Comprehensive Income for the Period | 47,961 | (50,901) | Overview This section provides a discussion of the financial information and notes for the six months ended June 30, 2025, and should be read in conjunction with the relevant financial statements - This section's discussion is based on the financial information and notes contained in this announcement[105] Revenue For the six months ended June 30, 2025, total revenue increased by 51.3% to approximately RMB 621.0 million from approximately RMB 410.5 million in the prior year, primarily driven by increased revenue from model animal sales, preclinical pharmacological efficacy evaluation, and antibody development Revenue Details | Service Line | 2025 (RMB in thousands) | Share (%) | 2024 (RMB in thousands) | Share (%) | | :--- | :--- | :--- | :--- | :--- | | Gene Editing | 28,617 | 4.6 | 34,606 | 8.4 | | Preclinical Pharmacological Efficacy Evaluation | 155,031 | 25.0 | 81,552 | 19.9 | | Model Animal Sales | 274,426 | 44.2 | 175,772 | 42.8 | | Antibody Development | 162,863 | 26.2 | 118,200 | 28.8 | | Others | 26 | 0.0 | 369 | 0.1 | | Total Revenue | 620,963 | 100.0 | 410,499 | 100.0 | - Revenue increased by 51.3%, primarily due to increased revenue from model animal sales, preclinical pharmacological efficacy evaluation, and antibody development[107] Cost of Sales Cost of sales increased by 51.4% to approximately RMB 159.0 million from approximately RMB 105.0 million in the prior year, largely consistent with the increase in revenue during the reporting period - Cost of sales increased by 51.4% to approximately RMB 159.0 million from approximately RMB 105.0 million, largely consistent with the increase in revenue during the reporting period[108] Gross Profit and Gross Margin Gross profit increased by 51.2% to approximately RMB 461.9 million from approximately RMB 305.5 million in the prior year, mainly due to increased revenue, with the gross margin remaining stable at 74.4% in both reporting periods - Gross profit increased by 51.2% to approximately RMB 461.9 million, primarily due to increased revenue from model animal sales, preclinical pharmacological efficacy evaluation, and antibody development[109] - Gross margin remained stable at 74.4% for the six months ended June 30, 2024, and 2025[109] Other Income and Losses, Net For the six months ended June 30, 2025, other income and losses, net, totaled approximately RMB 8.5 million, a 10.5% decrease from the prior year, primarily due to reduced interest income and net exchange gains - Other income and losses, net, totaled approximately RMB 8.5 million, a 10.5% decrease from the prior year[110] - The decrease was primarily due to reduced interest income and net exchange gains[110] Net Change in Fair Value of Biological Assets The net change in fair value of biological assets increased by 220.0% to approximately RMB 20.8 million from approximately RMB 6.5 million in the prior year, primarily due to higher inventory levels of humanized mice - The net change in fair value of biological assets increased by 220.0% to approximately RMB 20.8 million[111] - The increase was primarily due to a higher inventory level of humanized mice for the six months ended June 30, 2025, compared to the prior year[111] Selling and Marketing Expenses Selling and marketing expenses increased by 37.6% to approximately RMB 58.5 million from approximately RMB 42.5 million in the prior year, primarily due to increased salaries, largely consistent with the revenue growth during the reporting period - Selling and marketing expenses increased by 37.6% to approximately RMB 58.5 million[112] - This increase was primarily due to increased salaries, largely consistent with the revenue growth during the reporting period[112] General and Administrative Expenses General and administrative expenses increased by 13.3% to approximately RMB 116.2 million from approximately RMB 102.6 million in the prior year, primarily due to increased staff costs from bonuses and share-based payments - General and administrative expenses increased by 13.3% to approximately RMB 116.2 million[113] - The increase was primarily due to increased staff costs from bonuses and share-based payments arising from accelerated vesting during the reporting period[113] Research and Development Expenses Research and development expenses increased by 29.3% to approximately RMB 209.1 million from approximately RMB 161.7 million in the prior year, primarily due to increased staff costs (attributable to bonuses and an increase in R&D employee headcount) and higher direct material costs - Research and development expenses increased by 29.3% to approximately RMB 209.1 million[114] - The increase was primarily due to increased staff costs (attributable to bonuses and an increase in R&D employee headcount) and higher direct material costs[114] Liquidity and Capital Resources As of June 30, 2025, bank and cash balances totaled approximately RMB 479.6 million, primarily driven by strong positive cash flow from operating activities, with net cash from operating activities significantly increasing to RMB 203.4 million, achieving positive net cash flow - As of June 30, 2025, bank and cash balances totaled approximately RMB 479.6 million, with the increase primarily due to strong positive cash flow from operating activities[115] Condensed Interim Consolidated Cash Flow Statement Summary | Item | 2025 (RMB in thousands) | 2024 (RMB in thousands) | | :--- | :--- | :--- | | Tax Paid | (16,041) | (3,076) | | Net Cash from Operating Activities | 203,434 | 29,608 | | Net Cash Used in Investing Activities | (82,898) | (31,964) | | Net Cash Used in Financing Activities | (87,284) | (13,465) | | Net Increase/(Decrease) in Cash and Cash Equivalents | 33,252 | (15,821) | | Effect of Exchange Rate Changes | 3,357 | 2,066 | | Cash and Cash Equivalents at January 1 | 384,458 | 399,607 | | Cash and Cash Equivalents at End of Period | 421,067 | 385,852 | Finance Costs For the six months ended June 30, 2025, finance costs amounted to approximately RMB 35.9 million, a 31.9% decrease from the prior year, primarily due to reduced interest on long-term payables - Finance costs decreased by 31.9% to approximately RMB 35.9 million, primarily due to reduced interest on long-term payables[116] Bank and Other Borrowings and Gearing Ratio As of June 30, 2025, the Group's outstanding borrowings were approximately RMB 401.8 million, and its gearing ratio was 1.77, a decrease from 1.88 as of December 31, 2024 - As of June 30, 2025, the Group's outstanding borrowings were approximately RMB 401.8 million[117] - The Group's gearing ratio was 1.77 (December 31, 2024: 1.88)[117] Net Current Assets As of June 30, 2025, the Group's net current assets were approximately RMB 418.6 million, a significant increase from approximately RMB 281.6 million as of December 31, 2024 - As of June 30, 2025, the Group's net current assets were approximately RMB 418.6 million, compared to approximately RMB 281.6 million as of December 31, 2024[118] Foreign Exchange Risk Fluctuations in exchange rates between the US dollar and other currencies used in the Group's operations may impact its financial position and operating results; the company currently has no foreign currency hedging policy, but management monitors foreign exchange risk and considers hedging when necessary - Fluctuations in exchange rates between the US dollar and other currencies used in the Group's operations may impact the Group's financial position and operating results[119] - The company currently has no foreign currency hedging policy, but management monitors foreign exchange risk and will consider hedging when necessary[119] Capital Expenditure For the six months ended June 30, 2025, total capital expenditure amounted to approximately RMB 30.8 million, primarily allocated to investments in facilities and office buildings, and the purchase of scientific equipment - For the six months ended June 30, 2025, total capital expenditure amounted to approximately RMB 30.8 million, primarily including investments in facilities and office buildings, and the purchase of scientific equipment[120] Contingent Liabilities As of June 30, 2025, the Group had no material contingent liabilities - As of June 30, 2025, the Group had no material contingent liabilities[121] Pledge of Assets The Group has pledged its property and buildings, as well as machinery and equipment, for bank and other borrowings; as of June 30, 2025, the total net book values of the related assets were RMB 225.1 million, RMB 18.3 million, and RMB 26.0 million, respectively - The Group has pledged its property and buildings, as well as machinery and equipment, for bank and other borrowings[122] - As of June 30, 2025, the total net book values of property and buildings, right-of-use assets, and machinery and equipment were RMB 225.1 million, RMB 18.3 million, and RMB 26.0 million, respectively[122] Material Investments As of June 30, 2025, the Group had no material investments - As of June 30, 2025, the Group had no material investments[124] Material Acquisitions and Disposals For the six months ended June 30, 2025, the company did not undertake any other material acquisitions or disposals of subsidiaries, associates, and joint ventures - For the six months ended June 30, 2025, the company did not undertake any other material acquisitions or disposals of subsidiaries, associates, and joint ventures[125] Events After Reporting Period Except for the disclosed matters, the company is not aware of any other material post-reporting period events from June 30, 2025, up to the date of this announcement - Except for the disclosed matters, the company is not aware of any other material post-reporting period events from June 30, 2025, up to the date of this announcement[126] Employees and Remuneration Policy As of June 30, 2025, the company had 1,306 employees, an increase from 1,117 as of December 31, 2024; the company offers competitive remuneration, stock incentive plans, and continuous education and training to enhance employee retention - As of June 30, 2025, the company had 1,306 employees (December 31, 2024: 1,117 employees)[127] - The company offers competitive remuneration, stock incentive plans, and continuous education and training to enhance skills and knowledge, contributing to good employee relations and improved employee retention[127] Future Plans for Material Investments and Capital Assets Except as disclosed in this announcement, as of June 30, 2025, the company had not approved any plans for material investments or acquisitions of capital assets - Except as disclosed in this announcement, as of June 30, 2025, the company had not approved any plans for material investments or acquisitions of capital assets[128] Corporate Governance and Other Information This section details the company's corporate governance practices, compliance with regulatory codes, and other administrative information relevant to its operations Interim Dividends The Board does not recommend the payment of an interim dividend for the six months ended June 30, 2025 - The Board does not recommend the payment of an interim dividend for the six months ended June