[一季报]华东医药(000963):2023年第一季度报告（英文版）
原标题:华东医药:2023年第一季度报告（英文版） First Quarterly Report 2023 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 report is authentic, accurate and 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 supervisor) 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 Is the Company required to adjust or restate retroactively the accounting data in previous years?
Total share capital of the Company as at the trading date prior to disclosure:
(II) Non-recurring profit or loss items and amounts ?Applicable □ Not applicable
The Company had no other profit or loss item conforming to the definition of non-recurring profit or loss. If an item listed as non-recurring profit or loss item in the Explanatory Announcement on Information Disclosure by Companies Offering Securities to the Public No. 1: Non-Recurring Profits and Losses is defined as a recurring profit or loss item, please describe the details. □Applicable ?Not applicable The Company did not define any item listed as non-recurring profit or loss item in the Explanatory Announcement on Information Disclosure by Companies Offering Securities to the Public No. 1: Non-Recurring Profits and Losses as a recurring profit or loss item. (III) Details and reasons for changes in key accounting data and financial indicators
II. Shareholder Information (I) Total number of ordinary shareholders, number of preferred shareholders with restored voting rights and shareholdings of top 10 shareholders Unit: Shares
(II) Total number of preferred shareholders of the Company and shareholdings of top 10 shareholders □Applicable ?Not applicable III. Other Important Matters ?Applicable □ Not applicable (I) Overview of the Company's overall operations during the reporting period In the first quarter of 2023, the Company, with a sharp focus on the overall strategic planning and annual business objectives, continued to thoroughly implement its unique business philosophy and the business principles of "High-quality Innovation, High-efficiency Operation" in the new era, continuously improved the average labor efficiency per capita, enriched the pipeline layout, strengthened the construction of the R&D ecosystem, improved the R&D speed and quality, and actively expanded the international market. Moving forward steadily along the road of transformation and innovation with Huadong Medicine's characteristics, the Company has achieved an all-round recovery of overall operating performance and a steady improvement in growth and quality, laying a solid foundation for achieving the overall business objectives for the year. From January to March 2023, the Company achieved an operating income of CNY 10.115 billion, the first time that the operating income exceeded CNY 10 billion in a single quarter, an increase of 13.23% year on year and an increase of 2.62% from the fourth quarter of 2022; during the reporting period, with the equity incentive cost and the profit or loss from shareholding and controlling R&D institutions deducted, it achieved the net profit attributable to shareholders of the listed company after deducting non-recurring profit or loss of CNY 855 million, a year-on-year increase of 14.99%. During the reporting period, the overall operation of Zhongmei Huadong, a core subsidiary of the Company, continued to maintain a steady growth trend, achieving operating income (including CSO business) of CNY 3.075 billion, a year-on-year increase of 10.19%, and realizing consolidated net profit attributable to shareholders of the listed company after deducting non-recurring profit or loss of CNY 667 million, an increase of 15.90% year on year and an increase of 39.98% from the fourth quarter of 2022. During the reporting period, except for the orders for nucleoside intermediates affected by the decline in international market demand, the products and businesses in the Company's industrial microbiology sector maintained a steady growth. The Company will continue to improve its business layout, enhance its overall operating functions and strengthen its marketing capabilities, in an effort to make new breakthroughs in domestic and international market expansion, and fulfil the business objectives of maintaining rapid growth of operating income for the year of 2023. Affected by the periodical increase in demand for medicinal products, the growth of the Company's pharmaceutical business during the reporting period accelerated year on year; the overall operating income amounted to CNY 6.844 billion, a year-on-year increase of 15.67%, and the cumulative net profit increased by 15.06% year on year. During the reporting period, the Company's domestic and international aesthetic medicine business continued to maintain a sound momentum of growth. The total operating income of aesthetic medicine sector was CNY 503 million (excluding internal offsets), a year-on-year increase of 10.86%. Sinclair, a wholly-owned subsidiary in the United Kingdom, continued to expand the global aesthetic medicine market. During the reporting period, it achieved a consolidated operating income of GBP 33.8 million (approximately CNY 284 million), a year-on-year increase of 8.89%, and an EBITDA of GBP 2.99 million (the year-on-year slowdown was mainly due to the delay of orders in some regions, and the growth rate is expected to pick up gradually from the second quarter). During the reporting period, Sinclair (Shanghai), a domestic wholly-owned aesthetic medicine subsidiary of the Company, actively seized the opportunity of gradually recovering domestic aesthetic medicine market, and continued to expand the regenerative aesthetic medicine market on the premise of compliance with relevant regulations, based on the concept of "Medicine First", and with patient experience as the core. It achieved an operating income of CNY 210 million, an increase of 33.83% year on year and an increase of 10.51% as compared with the fourth quarter of 2022. As the domestic consumer market continues to recover, the Company is expected to achieve better performance in domestic aesthetic medicine business in the second quarter. (II) R&D and BD progress of the Company during the reporting period The Company attaches great importance to innovative R&D and continues to maintain a high proportion of R&D investment. During the reporting period, the Company's R&D investment in pharmaceutical industry was CNY 387 million, including CNY 306 million in direct R&D expenditure, and CNY 81 million in product introduction and R&D equity investment. As at the release date of the report, the important progresses made by the Company in the R&D and BD of medicinal products, innovative medical devices, aesthetic medicine products were as follows: 1. R&D progress (1) Oncology ELAHERE? (mirvetuximab soravtansine-gynx, R&D code: IMGN853, HDM2002): In July 2022, the subject enrollment for the PK pharmacokinetic study in Phase I clinical trial in China was completed. In November 2022, ImmunoGen, a US partner of the Company, announced the drug approved by the U.S. FDA for platinum-resistant ovarian cancer. It is used for the treatment of platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in adults who are folate receptor α (FRα)-positive and have previously received first to third-line systemic therapy. In December 2022, the subject enrollment for Phase III single-arm clinical trial in China was completed. In March 2023, the pre-BLA submission was completed after the preset primary endpoint of study was reached; and the BLA application is planned to be submitted within this year. Based on the good clinical performance of this product, the Company and its partner will promote the front-line treatment of ovarian cancer through further clinical study, to support the use of ELAHERE? as the first choice in combination therapy for ovarian cancer. Mefatinib: It is used for the treatment of advanced non-small cell lung cancer with sensitive EGFR mutations. In June 2021, the enrollment of last subject for Phase III clinical trial was completed; and the subjects were been followed up for the number of PFS events. It is expected to submit the NDA application after the number of PFS events in the Phase III study is obtained in the second quarter of 2023. (2) Autoimmunity HDM3002 (PRV-3279): It is used to treat systemic lupus erythematosus (SLE) and prevent or reduce the immunogenicity of gene therapy. Provention Bio, a US partner of the Company, is currently conducting Phase IIa clinical trial of the product for SLE indication in the United States and Hong Kong, China. The Company submitted the IND application in China in February 2023. HDM3001: It is a biosimilar of ustekinumab for the treatment of moderate to severe plaque psoriasis in adults. The Phase III clinical study has reached the preset primary endpoint. The Company completed the pre-BLA submission in April 2023. (3) Endocrinology and metabolism HDM1002: It is a small molecule GLP-1 receptor agonist independently developed by the Company. The Company submitted the IND application in China in February 2023, and completed the submission of IND application in the United States in April 2023. Liraglutide Injection: It is a GLP-1 receptor agonist. The marketing authorization application for diabetes indication was approved by NMPA in March 2023. The marketing authorization application for obesity or overweight indication was accepted in July 2022 and it is expected to be approved within this year. Semaglutide Injection: The Phase I study has been completed and reached the endpoint of the equivalence study. Phase III clinical study is expected to be initiated in the second half of 2023. Insulin Degludec Injection: The Phase I study has been completed and reached the endpoint of (4) Innovative medical device HD-NP-102 (Transdermal Glomerular Filtration Rate Measurement System and MB-102 Injection): It is jointly developed by the Company and MediBeacon, Inc. in the United States, and is used to continuously measure the glomerular filtration rate (GFR) of patients with normal or impaired renal function in a non-invasive manner based on the changes in fluorescence over time emitted by the intravenously injected MB-102. In July 2022, the medical device registration application for the system was formally accepted by NMPA, which is currently under review. The MB-102 Injection (Relmapirazin) used in conjunction with the system is a global innovative drug. The subject enrollment for Phase III multi-regional clinical trial (MRCT) was completed in February 2023, and the pre-NDA submission in China was completed in April 2023. (5) Registration and commercialization progress of aesthetic medicine products During the reporting period, the Company continued to push ahead the registration and promotion of core products in the global market: 1) Injectables ? ? Ellansé series ? The subject enrollment for clinical trial of Ellansé -M in China has been successfully completed, ? and the follow-up has been started. In addition, Sinclair has initiated the registration of Ellansé products, a range of injectable polycaprolactone microsphere-based dermal fillers, in the United States. ? ? MaiLi series The subject enrollment for clinical trial of MaiLi Extreme in China has been successfully completed, and the follow-up has been started. In addition, Sinclair has initiated the registration of ? MaiLi series products, a new range of injectable premium lidocaine-containing hyaluronic acid fillers, in the United States. 2) Energy-based devices ? Sculpt ＆ Shape In the first quarter of 2023, Sinclair launched Sculpt & Shape, a new energy-based device for body shaping and facial rejuvenation, in the European market. Featuring innovative RotateRF technology, the product received good market feedback immediately after it was launched. ? ? Reaction ? The Company has initiated the pre-marketing preparations for Reaction , a bipolar radio frequency anti-aging device, in China, and has established a national energy-based device sales team. In April 2023, a pre-marketing clinical application seminar was held in China, when 6 authoritative experts in dermatology and plastic surgery were invited to conduct exchanges and discussions. The product is planned to be marketed in the second quarter of 2023 in China. 2. Pharmaceutical BD cooperation of the Company In January 2023, Huadong Medicine (Hangzhou) Co., Ltd., a wholly-owned subsidiary of the Company, signed an exclusive commercialization cooperation agreement with Kaixing Life Science, a wholly-owned subsidiary of CARsgen Therapeutics Co., Ltd. Huadong Medicine (Hangzhou) has been granted by Kaixing Life Science the exclusive rights for commercialization of zevorcabtagene autoleucel (R&D code: CT053), a fully human anti-autologous BCMA (B cell maturation antigen) CAR-T (chimeric antigen receptor T cell) candidate for the treatment of relapsed/refractory multiple myeloma. As a product with great potential, zevorcabtagene autoleucel will further enrich the Company's product line in the field of blood diseases. In terms of marketing, it will share expert networks, research and clinical resources with existing key product varieties in this field, to achieve mutual promotion and development and generate effective synergies. After this transaction, the Company will form a multi-dimensional pipeline layout of chemotherapeutic drugs, ADC products and CAR-T products in the treatment of hematological tumors. For details, please refer to the Announcement on Exclusive Commercialization Cooperation Agreement Signed by a Wholly-owned Subsidiary (Announcement No.: 2023-004) disclosed by the Company at http://www.cninfo.com.cn. In April 2023, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as "Zhongmei Huadong"), a wholly-owned subsidiary of the Company, signed the Agreement on Equity Transfer and Capital Increase in Jiangsu Nanjing Nongda Animal Pharmaceutical Co., Ltd. with Jiangsu Nanjing Nongda Animal Pharmaceutical Co., Ltd. (hereinafter referred to as "Nanjing Nongda Animal Pharmaceutical"), Zhai Zhongshu and Nanjing Jiuheng Pharmaceutical LP (Limited Partnership). Zhongmei Huadong will invest no more than CNY 265,333,300 in total and acquire 70% of the equity in Nanjing Nongda Animal Pharmaceutical in the form of equity transfer and capital increase, to become a controlling shareholder of the latter. This acquisition of Nanjing Nongda Animal Pharmaceutical further improves the industrial layout of the Company in industrial microbiology. Nanjing Nongda Animal Pharmaceutical is at a stage of rapid growth. The average annual growth rate of sales revenue in the past three years has exceeded 50%.The preliminary construction has laid a solid foundation for its rapid development. After this transaction, Nanjing Nongda Animal Pharmaceutical will become an important platform for Huadong Medicine to develop its animal health business in industrial microbiology sector, while making full use of Huadong Medicine’s advantages in industrial ecological chain and financial support capabilities to achieve coordinated development in R&D, manufacturing, marketing, selling and other dimensions. For Animal Pharmaceutical Co., Ltd. Through Equity Transfer and Capital Increase (Announcement No.: 2023-024) disclosed by the Company at http://www.cninfo.com.cn. (III) Reception of research, communication, interview and other activities during the reporting period
(IV) Innovation progress of the Company 1. Pharmaceutical industry Huadong Medicine's R&D of innovative drugs are aimed to build excellent innovative drug discovery capabilities, strong biotechnological R&D capabilities, and efficient clinical development capabilities to address the unmet clinical needs of global patients. With the continuous enrichment of product pipeline, the Company has continuously expanded in the field of innovative drugs to cover the R&D of small molecule drugs, polypeptide drugs, antibody-drug conjugates (ADCs), bispecific or multi-specific antibody drugs and other types of drugs, while exploring the innovative therapies for metabolic, autoimmune, neoplastic and other diseases. (1) Continuous improvement of innovative R&D ecosystem with Huadong Medicine’s characteristics The Company has established an international capable and efficient innovative drug R&D team consisting of various high-level talents from the whole industry chain, and has more than 500 core technical talents in the innovative drug R&D ecosystem. The enterprises in the ecosystem cooperate closely with each other to implement the research and development projects smoothly as follows: 1) Qyuns Therapeutics is one of the companies with the most comprehensive pipeline of biological drugs and the most advanced overall development schedule in the field of autoimmune and allergic diseases in China. At present, Qyuns Therapeutics' product pipeline covers skin, respiratory, digestive, and rheumatic diseases, including psoriasis, atopic dermatitis, ankylosing spondylitis, inflammatory bowel disease, systemic lupus erythematosus and asthma. It has a leading API production base, including four 2000L disposable bioreactors and a downstream purification/production line, with an annual production capacity of approximately 300KG therapeutic antibodies. In March 2023, Qyuns Therapeutics submitted an application for IPO on the Stock Exchange of Hong Kong Limited. The Phase III study of Project HDM3001 has reached the preset primary endpoint. The Company completed the pre-BLA submission in April 2023 and is expected to submit the BLA application in the third quarter of 2023. 2) Heidelberg Pharma is a global biopharmaceutical company focusing on the research and ? development of anticancer ADC drugs. Heidelberg Pharma has a proprietary ATAC (Antibody Targeted Amanitin Conjugates) technology platform and is the first company in the world to develop amanitin and its derivatives for cancer treatment. At present, clinical progress is made in Project HDP-101; the IND development is advanced in Project HDP-103; and an early study on a new ? generation of ADCs based on the ATAC platform is undergoing. 3) Doer Biologics focuses on the development of multi-domain-based multi-specific innovative recombinant PEGylation (rPEG) platform for long-acting transformation of biological drugs, MultipleBody, a multi-domain fusion protein technology platform, AccuBody, a precision tumor treatment technology platform, and HTS-VHHBody, a high-throughput discovery and engineering platform for domain antibodies. The Project DR30303 in oncology is currently at Phase I clinical trial in China; the Project DR10624 in Metabolism is currently at Phase I clinical trials in New Zealand, and the Phase I multiple ascending dose (MAD) phase will be started soon. 4) Chongqing PEG-BIO is specialized in the independent R&D of genetically engineered recombinant proteins and polypeptide drugs. At present, it has MAS-PEG, a platform that employs a variety of key technologies to solve major defects such as short half-life and high immunogenicity of macromolecular drugs in vivo and finally realizes long-acting, low immunogenicity and long-term macromolecular drugs (therapeutic enzymes), and TE-Peptides, a polypeptide tandem recombination high-efficiency expression platform that adopts unique patented design, high-density fermentation, unique enzyme digestion, modification technology and purification technology to obtain products, and has the advantages of no optical isomers, no missing peptides, short production cycle, high yield and much lower manufacturing cost. In terms of Semaglutide Injection, the Phase I study has been completed and reached the endpoint of the equivalence study. It is expected to initiate Phase III clinical study in the second half of 2023. The Company will continue to strengthen the construction of Huadong Medicine's R&D ecosystem. In the future, it will focus on the layout centering on a new generation of nucleic acid drugs, drugs used in cell and gene therapy, etc., expand the technology platform of R&D ecosystem, and continuously enrich the pipeline of differentiated and leading innovative pharmaceutical products. (2) Enriching the ADC product pipeline and creating a differentiated independent R&D platform of Huadong Medicine As at the end of the reporting period, the introduced ADC projects, including HDM2002 (ELAHERE?), HDP-101 and HDP-103, were implemented smoothly, among which HDM2002 (ELAHERE?) is the world’s first ADC being developed by Huadong Medicine and ImmunoGen for the treatment of folate receptor alpha (FRα)-positive ovarian cancer. In November 2022, ImmunoGen, a strategic partner of the Company, announced the accelerated approval of ELAHERE? by the U.S. FDA. It is the first ADC drug approved by the U.S. FDA for platinum-resistant ovarian cancer. The Company completed the Pre-BLA submission in China in March 2023, and plans to submit a BLA application within this year. HDP-101, a BCMA-targeted ADC drug for multiple myeloma, is introduced from Heidelberg Pharma and is currently at the stage of Phase I/II clinical study overseas; HDP-103, a PSMA-targeted ADC drug for prostate cancer, is introduced from Heidelberg Pharma So far, Huadong Medicine's innovative R&D ecosystem has formed a system and has begun to continuously introduce new pipeline projects. The Company established an independent ADC R&D center last year, which is aimed to gradually build a differentiated independent ADC R&D platform, strengthen and optimize the ecological chain in the ADC field, develop no less than 10 innovative ADC products in 2022-2024, and actively promote registered clinical studies. Up to now, 6 preclinical or exploratory newly-targeted ADC projects have been established independently. It is expected that at least 4 additional independently-developed products will be confirmed for PCC and 2 independently-developed ADC projects will be approved for IND before 2025. By now, the first original ADC project has completed PCC confirmation and is undergoing IND development; it is planned to apply for clinical study within 2024. The Company will continue to enlarge the layout in the field of anti-tumor ADC drugs, and continue to develop differentiated and iterative ADC products for different cancer types based on unmet clinical needs. (3) Pipeline progress 1) Oncology The Company strives to build a world-leading innovative anti-tumor drug R&D platform. Through the discovery, screening and validation of new targets in the early stage of drug development, it has established a product pipeline that covers more than 20 innovative anti-tumor drugs, including targeted small molecule drugs, ADCs, antibodies, and PROTACs, of which 4 clinical projects and 4 IND development projects have clinical competitive advantages in related indications including solid tumors and hematological tumors. As the Company continues to explore and validate more innovative targets, more drugs under development will be included in the development pipeline in the future, which provides an impetus for innovation, drives the continuous development of innovative drugs with better safety and clinical effect and offers patients more hope for a cure. 2) Endocrinology With the GLP-1 target as the core, the Company has built a world-leading innovative drug R&D platform for obesity, diabetes and diabetic complications. By now, the Company has established a product pipeline of GLP-1 and related targets that combines long-acting and multi-target global innovative drugs and biosimilars of oral, injectable and other dosage forms, including 4 clinical projects and 2 IND development projects, some of which have the potential to become a best-in-class （未完）  |