[三季报]华东医药(000963):2024年第三季度报告（英文版）
原标题:华东医药:2024年第三季度报告（英文版） Huadong Medicine Co., Ltd. Third Quarterly Report 2024 The Company and all members of the Board of Directors hereby guarantee that the information presented in this report is authentic, accurate and 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 quarterly report is authentic, accurate and complete and free of 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 supervisor) hereby declare that the financial information in this quarterly report is authentic, accurate and complete. 3. Has the Third 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 Does the Company need to retroactively adjust or restate the accounting data of previous years?
?Applicable □Not applicable
□Applicable ?Not applicable The Company has no other specific circumstances of profit and loss items that meet the definition of non-recurring profits and losses. An explanation of the fact that the non-recurring profit and loss items listed in the Explanatory Announcement No.1 on Information Disclosure by Companies that Offer Securities to the Public - Non-recurring Profits and Losses are defined as recurring profit and loss items □Applicable ?Not applicable The Company did not define the non-recurring profit and loss items listed in the Explanatory Announcement No.1 on Information Disclosure by Companies that Offer Securities to the Public - Non-recurring Profits and Losses as recurring profit and loss items. (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 top 10 shareholders Unit: Share
shares without trading restriction conditions in refinancing lending ? Applicable □ N/A Unit: Share
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 top 10 shareholders □ Applicable ? N/A III. Other Important Matters ? Applicable □ N/A (I) Overview of the Company’s overall operations during the reporting period During the reporting period, the Company faced numerous uncertainties in the macro-environment and profound changes and challenges within China's pharmaceutical industry. Despite these, the Company earnestly implemented its annual operation plan, operated in a standardized and stable manner, and proactively advanced various operation management tasks in line with its medium and long-term development strategy, resulting in stable growth in overall performance. From January to September 2024, the Company achieved the operating revenue of 31.478 billion yuan, up 3.56% year on year, the net profit attributable to shareholders of listed companies of 2.562 billion yuan, up 17.05% year on year, and the net profit attributable to shareholders of listed companies after deducting non-recurring gains/losses of 2.482 billion yuan, up 14.90% year on year. From January to September 2024, after deducting the equity incentive expenses and the profits and losses of participating and holding R&D institutions, the Company achieved the net profit attributable to shareholders of listed companies after deducting non-recurring gains/losses of 2.739 billion yuan, up 26.81% compared with the net profit attributable to shareholders of listed companies after deducting non-recurring gains/losses in the same period in 2023. In Q3 2024, the Company continued its favorable growth trend in the first half of the year. The Company achieved the total operating revenue of 10.513 billion yuan, up 5.03% year on year. The net profit attributable to shareholders of listed companies was 866 million yuan, up 14.71% year on year. The net profit attributable to shareholders of listed companies after deducting non-recurring gains/losses was 857 million yuan, up 16.93% year on year. From January to September 2024, the Company’s pharmaceutical industry segment achieved the operating revenue of 9.941 billion yuan (including CSO business), up 10.53% year on year, and the net profit attributable to the parent company of 2.140 billion yuan, up 14.49% year on year. Among them, in Q3 2024, the pharmaceutical industry segment achieved the operating revenue of 3.243 billion yuan (including CSO business), up 10.32% year on year, and the net profit attributable to the parent company of 755 million yuan, up 20.44% year on year. During the reporting period, the Company’s pharmaceutical business segment witnessed continuous and stable growth as a whole. From January to September 2024, the segment achieved the operating revenue of 20.571 billion yuan, up 1.38% year on year, and the net profit of 323 million yuan, up 2.09% year on year. During the reporting period, the Company’s aesthetic medicine segment witnessed stable growth as a whole. From January to September 2024, the segment achieved the total operating revenue of 1.909 billion yuan (excluding internal offsetting factors), up 1.90% year on year. Sinclair, the Company’s wholly-owned subsidiary and the global operating platform of its aesthetic medicine business based in the UK, proactively expanded sales of its aesthetic medicine injection, fillers and EBD products globally. During the reporting period, affected by sluggish global economic growth and other factors, Sinclair achieved the operating revenue of about 776 million yuan from January to September 2024, down 20.30% year on year. From January to September 2024, Sinclair (Shanghai), the Company’s wholly-owned subsidiary for its aesthetic medicine business, achieved the operating revenue of 909 million yuan, up 10.31% year on year, witnessing continuous improvement in profitability and making important contribution to the continuous growth of the Company’s overall performance. In the future, the Company will intensify its efforts to integrate global resources and will continue to advance the registration, admission, global coverage in potential markets, and market share expansion of its core products. Currently, the Company has comprehensively facilitated the registration of its products in key overseas aesthetic medicine markets. Sinclair's entire injection portfolio has been registered and launched in over ten core markets in the Middle East. Additionally, more than half of the procedures for registering its EBD core products in the Middle East's key ? markets have been completed. The registration of various core injectable products, such as Ellansé S, MaiLi, and KIO015, is actively progressing in the U.S. With the gradual launch of its core product lines in key overseas markets, the Company is expected to enhance its brand impact and core competitiveness, thereby continuously fueling its growth in the international aesthetic medicine sector. In the meantime, the Company will facilitate the launch of its high-end aesthetic medicine products in the domestic market and continue to enrich its product portfolio to capitalize on the emerging growth of Huadong Medicine’s aesthetic medicine business. During the reporting period, the Company made active progress in the international market expansion of its industrial microbiology segment, witnessing a favorable overall growth trend. From January to September 2024, the segment achieved operating revenue of 443 million yuan, up 30.17% year on year. With the continuous expansion of its overseas markets and a constant increase in the number of clients, the industrial microbiology segment is expected to maintain rapid growth. 1. Overall R&D situation During the reporting period, being “Scientific Research-based and Patient-centered”, the Company further devoted itself to the treatment in the fields of endocrinology, autoimmunity and oncology, continuously increased the R&D input, kept enriching the layout of innovative medicine R&D, enhanced the construction of innovative R&D ecology and technological platform, and actively advanced the progress of clinical trials, with multiple major staged achievements made. From January to September 2024, the Company’s R&D investment in the pharmaceutical industry (excluding equity investment) was 1.607 billion yuan, up 0.60% year on year. Among them, direct R&D expenditure was 1.149 billion yuan, up 12.41% year on year, which accounts for 11.69% of the operating revenue of the pharmaceutical industry. 2. Innovative R&D lines The Company placed the focus of its innovative R&D on three core fields of oncology, endocrinology and autoimmunity. To date, there have been over 70 innovative product lines. As its product lines are continuously enriched, the Company has constantly expanded its innovative medicine field to the R&D of multiple types of medicines including small-molecule medicines, polypeptides, ADCs, bispecific or multispecific antibody medicines, as well as the exploration towards innovative therapies for diseases in the fields of endocrinology, autoimmunity and oncology. 3. Progress of R&D of innovative medicines, innovative medical apparatuses and biosimilar medicines Oncology The Company endeavored to build the world’s leading platform for R&D of innovative cancer medicines and established more than 30 innovative antineoplastic medicines covering targeted small-molecule medicines, ADCs, antibodies, PROTAC, etc. through discovery, screening and verification of new targets in preliminary R&D of medicines. ? The marketing authorization application in China of ELAHERE (R&D code: IMGN853, HDM2002), the world’s first-in-class Mirvetuximab Soravtansine Injection, introduced by the Company, for platinum-resistant ovarian cancer, was accepted and is now under comprehensive review. Passing the innovative policy approval of “Hong Kong & Macao Registered Medicine Access to GBA Program” in August 2024, the product was launched in the Guangdong-Hong Kong-Macao Greater Bay Area to benefit more patients. The marketing authorization application of Mefatinib Tablet, the Company’s first-class new medicine, for the first-line treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) patients with an exon L858R mutation in EGFR 21 was accepted in May 2024. The clinical and pharmaceutical inspections were completed in September and October 2024, respectively, and the application is now under review. HDM2005, an ADC product independently developed by the Company and receptor tyrosine kinase-like orphan receptor 1 (ROR1), is used for the treatment of advanced malignant neoplasm. The Company completed the enrollment of the first subject in clinical trial in China in August 2024. At present, the study is in the stage of third dose escalation. The IND application in China of HPK-1 PROTAC (hematopoietic progenitor kinase1 proteolysis targeting chimera), the Company’s first self-developed small-molecule anti-tumor medicine HDM2006, was approved in October 2024. The product is used for the treatment of advanced solid tumors. The IND application in China of HDM2027 (HDP-101), an innovative medicine introduced by the Company, was approved in October 2024. The product is used for the treatment of clonal hematological diseases with positive B cell maturation antigen (BCMA), such as recurrent/refractory multiple myeloma. The company's self-developed ADC products with innovative targets, HDM2020, HDM2012 and HDM2017, have completed PCC confirmation and entered the IND R&D stage. IND applications in China and the U.S. are expected to be submitted in 2025. Endocrinology HDM1002, an oral small-molecule GLP-1 receptor stimulant developed independently by the Company, completed the enrollment of all subjects for clinical trial for overweight or obesity phase II indications. The top-line results are expected to be obtained in October 2024. The pre-III phase communication is expected to be conducted in Q4 2024. In the meantime, the enrollment of the first subject for clinical trial for diabetes mellitus phase II indication was completed. Phase Ia and phase Ib clinical trials in China of the GLP-1/GIPR dual-target long-acting agonist HDM1005 independently developed by the Company are smoothly progressing. It is anticipated that the phase Ia clinical research report and the top-line results from phase Ib (Part I) will be available in Q4 2024. Phase II clinical trial is expected to be initiated in early 2025. DR10624, a multiple agonist targeting FGF21R/GCGR/GLP-1R developed by Zhejiang Doer Biologics Co., Ltd., a holding subsidiary of the Company, is currently undergoing phase Ib/IIa clinical trials for obesity with hypertriglyceridemia in New Zealand. The phase II clinical trial for severe hypertriglyceridemia in China has been initiated, and the enrollment and dosing of the first subject have been completed. To date, Semaglutide Injection has completed the enrollment of all subjects in the phase III clinical study for diabetes indication. It is expected that the main endpoint data will be obtained and pre-BLA communication will be submitted in Q4 2024. IND application for Semaglutide Injection for weight management has been approved by the end of September 2024. Insulin Degludec Injection completed the enrollment of all subjects during phase III clinical study. It is expected that main end-point data will be obtained in Q4 2024. Insulin Degludec and Insulin Aspart Injection completed the enrollment of the first subject during phase III clinical study in August 2024. Autoimmunity The Company has had over 10 varieties of biomedicines and small-molecule innovative products in the field of autoimmunity. ? Rilonacept for Injection (ARCALYST ), a globally innovative product from Kiniksa in the U.S., is used for the treatment of Cryo-Pyrin-Associated Periodic Syndromes (CAPS) and recurrent pericarditis (RP). The marketing authorization applications for both CAPS and RP are currently under review. The marketing authorization application in China of HDM3001 (QX001S), a biological similar of Ustekinumab for plaque psoriasis developed by the Company in cooperation with Qyuns Therapeutics, is under comprehensive review. The innovative medicine HDM3016 (QX005N) in cooperation with Qyuns Therapeutics completed enrollment of the first subject for phase III clinical study for two indications of prurigo nodularis and atopic dermatitis in May 2024. The products in cooperation with Arcutis of the U.S., Roflumilast Cream (0.3%) for plaque psoriasis in patients aged 6 or above, Roflumilast Foam (0.3%) for seborrheic dermatitis in patients aged 9 or above, and Roflumilast Cream (0.15%) for atopic dermatitis in adults and children aged 6 or above, have all been approved by the FDA. In September 2024, Arcutis announced that the FDA has accepted their sNDA for Roflumilast Foam (0.3%) to treat scalp and body psoriasis in adults and adolescents aged 12 or above. In addition, the IND applications for Roflumilast Cream for the indications of atopic dermatitis and plaque psoriasis in China were approved in September 2024. The enrollment of the first subject is expected to be completed in Q4 2024. Innovative pharmaceutical devices The Dynamic Monitoring System of Glomerular Filtration Rate and Relmapirazin Injection review stage in China. Additionally, MediBeacon has submitted all documents regarding the ? marketing authorization application of the MediBeacon Dynamic Monitoring System of Glomerular Filtration Rate (including the dynamic monitoring system and Relmapirazin Injection) to the FDA by means of rolling submission, which was formally accepted in July 2023 and is now under review. To date, all clinical, pharmaceutical, and medical device production inspections have been completed. 4. Approval of generic medicines
5. Progress of aesthetic medicine registration (1) Progress of aesthetic medicine products in China
(2) Progress of overseas registration of cosmetic medicine products In the meantime, the Company has continued to plan and promote the overseas registration of its aesthetic medicine products. The MaiLi series of products received approval in Singapore in June 2024, and a new product launch conference took place on July 30. KIO015, a dermal filler for injection, is currently undergoing technical review for EU CE certification and is expected to receive the certification in 2025. Currently, the Company has registered and launched all its injection products, ? ? including regenerative materials (Ellansé and Lanluma ), hyaluronic acid fillers (MaiLi and ? ? ? Perfectha ), and thread lifting products (Silhouette Soft and Silhouette Instalift ), in over ten major Middle Eastern markets. Additionally, the registrations of EBD core products like Cooltech, Elysion, （未完）  |