[一季报]华东医药(000963):2025年第一季度报告（英文版）
原标题:华东医药:2025年第一季度报告（英文版） First Quarterly Report 2025 The Company and all members of the Board of Directors hereby guarantee that the information presented in this report is authentic, accurate, complete, and free of any false records, misleading statements or material omissions.Important Declaration: 1. The Board of Directors, Board of Supervisors, directors, supervisors and senior management of Huadong Medicine Co., Ltd. (hereinafter referred to as the “Company”) hereby guarantee that the information presented in this report is authentic, accurate, complete, and free of any false records, misleading statements or material omissions, and shall undertake individual and joint legal liabilities. 2. The Company’s legal representative, the officer in charge of accounting, and the head of accounting department (accounting manager) hereby declare that the financial information in this quarterly report is authentic, accurate, and complete. 3. Has the First Quarterly Report been audited? □Yes ? No According to “Stock Listing Rules of the Shenzhen Stock Exchange”, if listed companies have both Chinese and other language version of public notice, they should ensure the content of both versions are the same. In the case of discrepancy, the original version in Chinese shall prevail. I. Key Financial Data (I) Key accounting data and financial indicators Whether the Company needs to perform a retroactive adjustment or restatement of previous accounting data
The Company’s total share capital as of the trading day prior to disclosure:
(II) Items and amounts of non-recurring gains/losses ? Applicable □ N/A
There are no other items of gains/losses meeting the definition of non-recurring gains/losses. Explanation for recognizing an item listed as a non-recurring gain/loss in the Interpretative Announcement No. 1 on Information Disclosure Criteria for Public Companies - Non-Recurring Gains/Losses as a recurring gain/loss □ Applicable ? N/A No item listed as a non-recurring gain/loss in the Interpretative Announcement No. 1 on Information Disclosure Criteria for Public Companies - Non-Recurring Gains/Losses is recognized as a recurring gain/loss. (III) Details and reasons for changes in key accounting data and financial indicators ? Applicable □ N/A Unit: ten thousand yuan
II. Shareholder Information (I) Total number of common shareholders, number of preferred shareholders with restored voting rights, and shareholdings of the top 10 shareholders Unit: share
shares without trading restriction conditions in lending through conversions □ Applicable ? N/A Change in the top 10 shareholders or the top 10 common shareholders without trading restrictions compared with the end of the previous period due to shares lent/returned through conversions □ Applicable ? N/A (II) Total number of preferred shareholders of the Company and shareholdings of the top 10 shareholders □ Applicable ? N/A III. Other Important Matters ? Applicable □ N/A (I) Overview of the Company’s overall operations in the reporting period During the reporting period, the Company remained closely aligned with its overarching strategic blueprint and annual operational objectives. Guided by the principles of “reinvigorating entrepreneurial spirit, deepening reforms, strengthening organizational systems, and seizing developmental opportunities,” the Company maintained a zero-based mindset and a relentless pursuit of excellence, vigorously advancing the effective implementation of various management initiatives. During the reporting period, the Company achieved an operating revenue of 10.736 billion yuan, up 3.12% year on year and up 2.95% compared with that in Q4 2024. The net profit attributable to shareholders of listed companies reached 915 million yuan, marking a 6.06% year-on-year increase. The net profit attributable to shareholders of listed companies after deducting non-recurring gains/losses stood at 897 million yuan, reaching a historic high with a 7.04% year-on-year increase and a 3.16% quarter-on-quarter increase from that in Q4 2024. After deducting the profits and losses of participating and holding R&D institutions, the net profit attributable to shareholders of listed companies after deducting non-recurring gains/losses during the reporting period amounted to 982 million yuan, reflecting a 17.15% growth compared with the Company’s net profit attributable to shareholders of listed companies after deducting non-recurring gains/losses in Q1 2024. During the reporting period, the Company’s core subsidiary Zhongmei Huadong witnessed steady growth as a whole and achieved an operating revenue (including CSO business) of 3.621 billion yuan, up 6.52% year on year, and the consolidated net profit attributable to the parent company of 843 million yuan, up 12.20% year on year. During the reporting period, the Company’s innovative medicines saw robust momentum in sales, driving sustained growth in the pharmaceutical industry. Leveraging its differentiated clinical value, the CAR-T Zevorcabtagene Autoleucel Injection ? (Saikaize ) has rapidly penetrated core treatment centers throughout China. With positive clinical feedback, the product maintained strong sales momentum in Q1 2025, marked by steadily increasing ? valid orders. The Company actively enhanced treatment accessibility, with Saikaize now covered by over 70 commercial insurance plans and regional Huiminbao programs (an urban customized commercial medical insurance) as of the reporting date, effectively alleviating patients’ financial burdens. Continued market expansion and broader insurance coverage are expected to sustain its ? high-speed growth trajectory. Sailexin , China’s first biosimilar of Ustekinumab Injection, has delivered exceptional market performance since its launch. By March 31, 2025, prescriptions for the product had been issued in over 800 hospitals, significantly benefiting psoriasis patients throughout China. The product is projected to maintain robust growth throughout the year, emerging as a cornerstone of the Company’s autoimmune disease portfolio. Furthermore, the novel Class 1 ? medicine Ganagliflozin Proline Tablets (Huiyoujing ) has been included in the updated catalogue of medicines covered by medical insurance, accelerating its hospital adoption. Strategic synergy with ? Metformin Hydrochloride and Empagliflozin Tablets (Enshuangping ) has accelerated resource ? diabetes management. The newly approved Senaparib Capsules (Paishuning ), a new 1.5-generation PARP inhibitor, was launched for sales in January 2025. The Company is actively working on the listing of the product on the procurement platform and facilitating its hospital access. To date, the ? Company has introduced Paishuning to over 100 DTPs and 300 hospitals, while actively pursuing inclusion in Huiminbao programs and commercial insurances, such as West Lake Yilian Insurance (a universe medical insurance in Hangzhou), Huhuibao (a universe medical insurance in Shanghai), Chonghuibao (a universe medical insurance in Nanchong), Jiaxing Huiminbao, and CPIC-Huxiangbao (a commercial insurance of CPIC in Shanghai). In August 2024, the Company completed the acquisition of Guizhou Hengba Pharmaceutical Limited Liability Company (renamed Huadong Medicine (Guizhou) Pharmaceutical Co., Ltd., hereinafter referred to as “Guizhou Pharma”). A dedicated in-house promotion team was established after the acquisition to accelerate the market ? penetration of its flagship product Shangkeling in major hospitals and retail pharmacies. This initiative has driven significant operational growth. During the reporting period, Guizhou Pharma achieved a strong start with an operating revenue of 24.26 million yuan, up over 100% year on year, and a net profit of 6.67 million yuan, surpassing its net profit in H1 2024. From its consolidation into the Company’s financial statements in August 2024 to the end of the reporting period, Guizhou Pharma generated a cumulative operating revenue of 62.28 million yuan and a cumulative net profit of 14.87 million yuan. It is projected to sustain its growth momentum in 2025. During the reporting period, the Company’s pharmaceutical business segment witnessed stable growth as a whole. The segment achieved an operating revenue of 6.934 billion yuan, up 3.23% year on year, and a net profit of 115 million yuan, up 7.33% year on year. During the reporting period, the Company’s aesthetic medicine segment faced certain pressures in growth imposed by dual challenges from global economic downturn and intensified industry competition. Continuously expanding its aesthetic medicine market globally, Sinclair, the Company’s wholly-owned subsidiary, achieved the consolidated operating revenue of approximately 238 million yuan, down 12.29% year on year, but up 24.37% quarter on quarter compared with that in Q4 2024, which align with its quarterly operational targets as a whole. Sinclair (Shanghai), the Company’s wholly-owned subsidiary, actively expanded its market in China and achieved an operating revenue of 254 million yuan, down 1.36% year on year, but up 10.64% quarter on quarter compared with that in Q4 2024. The Company has constantly deepened its layout of high-end aesthetic medicine ? ? ? portfolios in China. MaiLi Extreme (trade name: MaiLi Shuoying ), a high-end hyaluronic acid filler in the MaiLi series utilizing patented OxiFree? technology, is scheduled for commercial launch in May 2025. With the highest hyaluronic acid concentration and the best volumization effect among retrognathia correction, presenting more wonderful facial volumization solutions for Chinese patients. The Préime DermaFacial multi-functional facial skin management platform, an intelligent hi-tech cosmetic device that integrates IoT-enabled technologies such as spiral vacuum, microdermabrasion, micro current, and ultrasonic technique, will debut in 2025 to deliver one-stop personalized cleaning and anti-aging solutions to Chinese patients. The applications for the launch of key aesthetic medicine portfolios such as recombinant botulinum toxin type A YY001, energy source equipment V30, and ? Ellansé M in China have all been accepted and are expected to receive approvals in 2026. By continuously enriching its differentiated product matrix in China’s aesthetic medicine sector and capitalizing on consumption upgrade-driven market expansion, the Company is positioned to accelerate the release of growth potential in its aesthetic medicine business in China. During the reporting period, the Company’s industrial microbiology segment sustained rapid growth in revenue, up 29.98% year on year. With the ongoing proactive expansion in overseas markets, this segment is positioned to maintain its growth momentum moving forward. (II) Important R&D progress of the Company during the reporting period 1. Progress of R&D of innovative medicines, innovative medical devices and biosimilar medicines The Company further intensified its R&D efforts with increased investment. During the reporting period, the Company reported a pharmaceutical R&D input (excluding equity investments) of 880 million yuan, up 49.60% year on year. Among them, direct R&D expenditure reached 600 million yuan, up 71.77% year on year, which accounts for 16.67% of the operating revenue of the pharmaceutical industry segment. Multiple milestone achievements were attained in R&D of innovative and biosimilar medicines, with key progresses stated as follows: Oncology The supplemental application to convert the conditional approval of Mirvetuximab Soravtansine ? Injection (ELAHERE , R&D code: IMGN853, HDM2002) into full regular approval was accepted in March 2025. With regard to the ROR1-targeted ADC (HDM2005) for the treatment of advanced malignant tumors, the Company completed the first three dose-escalation cohorts in its phase I clinical trial in China, with no dose-limiting toxicities (DLT) observed. The Company is currently advancing to the fourth dose-escalation cohort while initiating expansion cohorts for the third dose level. In February 2025, the Company submitted an IND application to the NMPA for HDM2005 combined with R-CHP in previously untreated diffuse large B-cell lymphoma (DLBCL), which was accepted. The Company also received the Orphan Drug Designation (ODD) from the U.S. FDA for mantle cell The IND application of HPK-1 PROTAC (hematopoietic progenitor kinase1 proteolysis targeting chimera), a small-molecule anti-tumor medicine under HDM2006, in the U.S. was approved by FDA in January 2025. The product is used for the treatment of advanced malignant tumors. Moreover, the Company is currently conducting the phase I clinical trial in China for the treatment of advanced solid tumors. DR30206, a PD-L1/VEGF/TGF-β trispecific antibody fusion protein for injection, completed its first subject administration in phase Ib clinical trial for the treatment of non-small cell lung cancer in April 2025. The Company received approval for the clinical trial application for DR30206 in combination with standard chemotherapy for the treatment of patients with advanced or metastatic gastrointestinal tumors in April 2025. The enrollment of subjects for phase Ib clinical research is expected to begin in H1 2025. Endocrinology HDM1002 (conveglipron), an oral small-molecule GLP-1 receptor agonist, completed enrollment of the first subject for phase III clinical research for the indication of weight management in April 2025. It is scheduled to complete the enrollment of all subjects by the end of June 2025. The phase II clinical research for diabetes indication is progressing smoothly, with top-line results anticipated in Q3 2025. Phase III clinical research for diabetes indication is expected to be initiated in H2 2025. HDM1005 (poterepatide) injection, a GLP-1R/GIPR long-acting polypeptide dual-target agonist, is undergoing phase II clinical research for the indication of weight management and completed the enrollment of all subjects for phase II in April 2025. Phase III clinical research is expected to be initiated in Q4 2025. The Company also completed the enrollment of the first subject for phase II clinical trial for the indication of diabetes in April 2025. During the reporting period, the IND applications for new indications of HDM1005 Injection were approved by the NMPA successively, targeting the treatment of obstructive sleep apnea (OSA) in adults with obesity or overweight and heart failure with preserved ejection fraction (HFpEF) in adults with obesity or overweight, respectively. DR10624 Injection, a FGF21R/GCGR/GLP-1R trispecific agonist, is currently undergoing phase II clinical trials for metabolic dysfunction-associated steatotic liver disease (MASLD) with the first patient enrolled in April 2025. Concurrently, a previously initiated phase II clinical research of DR10624 for the treatment of severe hypertriglyceridemia completed the enrollment of all subjects, with unblinded top-line results anticipated in Q3 2025. The marketing authorization application of Semaglutide Injection for the indication of diabetes patient enrollment in phase III clinical research of Semaglutide Injection was completed in February 2025. The marketing authorization application of Insulin Degludec Injection was submitted in February 2025, which has been accepted. Autoimmunity The supplemental application for the new pediatric plaque psoriasis indication of HDM3001 (QX001S), a biosimilar of Ustekinumab developed in collaboration between the company and Qyuns Therapeutics, was approved in March 2025. Additionally, the marketing authorization application and supplemental application for the Crohn’s disease were accepted in February 2025. The innovative medicine HDM3016 (QX005N) developed in collaboration between the company and Qyuns Therapeutics is currently conducting phase III clinical trials in China for two indications of prurigo nodularis and atopic dermatitis. The enrollment of all subjects for phase III clinical research for prurigo nodularis was completed in March 2025. The IND application of HDM3019 (IMB-101) developed by the Company in partnership with IMBiologics (Republic of Korea) for the treatment of rheumatoid arthritis in China was approved in March 2025. Other segments The Transdermal Glomerular Filtration Rate System, a Class III innovative medical device, was approved by the NMPA in February 2025. The marketing authorization application for Relmapirazin Injection (MB-102) used cooperatively with the system was accepted by the NMPA in January 2024. ? Additionally, MediBeacon TGFR (including the Transdermal Glomerular Filtration Rate System and Relmapirazin Injection) was approved by the U.S. FDA in January 2025. Academic publications From 2025 to date, the Company’s innovation teams have successively published 11 posters or oral presentations at academic conferences in oncology, endocrinology/metabolism, and autoimmunity segments. Specifically: results of phase I clinical research of GLP-1/GIP dual-target long-acting agonist HDM1005 selected for oral presentation at 2025 ADA; results of phase III clinical research of Semaglutide Injection and phase Ib clinical research of HDM1002 selected for POSTER sharing at 2025 ADA; results of pre-clinical researches of HDM2006, HDM2022, HDM2012, HDM2017 and HDM2020 all selected as the POSTER of 2025 AACR; results of pre-clinical research of the pan-KRAS antitumor degrader HDM2025 selected as the POSTER of 2025 ASCO; results of clinical research of DR10624, a first-in-class Fc-fusion protein medicine with triple agonist activity targeting GLP-1, GCG, and FGFRIc/KlothoB (FGF21R) receptors developed by the Company’s clinical research results selected as the POSTER of 2025 EASL. 2. Progress of registration and launching of aesthetic medicine products in China During the reporting period, the Company continued to advance the registration and launching of its aesthetic medicine products. V30, a high-end integrated multi-functional platform combining radio frequency, intense pulsed light, and Nd:YAG laser technologies, received a registration acceptance notice from the National Medical Products Administration (NMPA) in March 2025. ? MaiLi Precise, a novel premium hyaluronic acid dermal filler with lidocaine (indication: correction of infraorbital pouch), completed main end-point follow-ups for all subjects in its Chinese clinical ? trial in September 2024 and is currently undergoing safety follow-ups. MaiLi Extreme, another filler in the same series (indication: enhancement of jawline contour), was approved by the NMPA in ? January 2025. For the Ellansé S, the enrollment of all subjects for the new indication (enhancement of forehead contour) in its Chinese clinical trial was completed in November 2024, and follow-ups ? are now in progress. Ellansé M, a long-acting collagen-stimulating variant (indication: correction of temporal depression), received the registration acceptance notice from the NMPA in January 2025. ? For the Poly-L-lactic acid (PLLA) collagen stimulant Lanluma (indication: enhancement of mandibular contour), the enrollment of all subjects in its Chinese clinical trial was completed in November 2024, and follow-ups are now in progress. The chitosan-based dermal filler KIO021 that utilizes innovative biomaterials secured ethical approval for principal investigator of clinical trial in December 2024 and is poised to initiate formal clinical trials. Additionally, the marketing authorization application for the exclusively distributed product YY001 (recombinant botulinum toxin type A for injection) was accepted by the NMPA in December 2024, and is currently under review. IV. Quarterly Financial Statements (I) Financial statements 1. Consolidated balance sheet Prepared by: Huadong Medicine Co., Ltd. March 31, 2025
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