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Public company info - Hansoh Pharmaceutical Group Company Limited , 03692.HK

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Hansoh Pharmaceutical Group Company Limited, 03692.HK - Company Profile
Chairman Zhong Huijuan
Share Issued (share) 5,919,000,000
Par Currency Hong Kong Dollar
Par Value 1.0E-5
Industry Medicine
Corporate Profile Business Summary: The group principally engaged in the research and development, production and sale of a series of pharmaceutical products in the People’s Republic of China (the “PRC”). Performance for the year: For the year ended December 31, 2019, the Group recorded revenue of approximately RMB8,683 million during the year under review, representing an increase of approximately 12.4% compared with the previous year; net profit of approximately RMB2,557 million, representing an increase of approximately 34.3% compared with the previous year. Business Review: In April 2019, an application for marketing was made in respect of the third-generation epidermal growth factor receptor (“EGFR”) inhibitor, almonertinib tablets (HS-10296), which was accepted for new drug priority review and is a self-developed innovative drug indicated for the treatment of patients with non-small cell lung cancer with EGFR-T790M mutation. It is expected to significantly prolong the life expectancy of targeted patients after its launch. In May 2019, the long-acting GLP-1 receptor agonist Fulaimei (polyethylene glycol loxenatide for injection), which is a self-developed innovative drug, was approved for launch, providing a better treatment choice for diabetes patients in China and significantly improving their medication experience and quality of life. In May 2019, the Group signed a cooperation agreement with Viela Bio, Inc. to develop CD19 monoclonal antibody inebilizumab in the PRC for the treatment of neuromyelitis optica spectrum disorder (“NMOSD”) as well as other autoimmune diseases and hematological malignancies. In November 2019, Hansoh Xinfu (flumatinib mesylate), a Category 1.1 innovative drug selfdeveloped by the Company, was approved for marketing in China and is indicated for the treatment of chronic myelogenous leukemia. During the year under review, the Group also obtained the production approvals for Apixaban tablets, Vildagliptin tablets, fosaprepitant dimeglumine for injection and canagliflozin tablets, all of which are domestic first-to-market generic drugs and together with linezolid tablets are considered to have passed the consistency evaluation. Cefdinir capsules were the first to pass the consistency evaluation. During the year under review, the application for the production of the Group’s innovative drug almonertinib was submitted, and the clinical trial application for HS-10342 was submitted and the Group obtained implied permission to conduct phase I clinical trials. In addition, the Group submitted applications for marketing in respect of Paliperidone extended-release tablets, Dabigatran etexilate capsules, dexlansoprazole enteric-coated capsules and lenalidomide capsules. During the year under review, the Group’s oncology injectable product Pulaile obtained U.S. FDA certification. The new 2019 edition of the NRDL was announced, in which the Group’s drugs listed in the 2017 edition were not removed and one drug, i.e. metformin hydrochloride repaglinide tablets, was included. The agreement with the National Healthcare Security Administration was renewed successfully through negotiation to enable the continuous inclusion of Mailingda in the NRDL. The construction of the high-end pharmaceutical products R&D center and phase 1 production base in Changzhou has been completed, which are to be put into use. The construction of the biological drugs production base started. During the year under review, the Company actively made adjustments in response to the national medical reform policy. Following the success of Oulanning and Xinwei being selected for the “4+7” scheme for centralized tendering with minimum procurement quantities, these two drugs further won the bid within the expanded nationwide range and maintained their stable growth throughout the year. In respect of the Group’s existing competitive areas, the Company strengthened academic facilities and publicity activities and continuously improved product coverage, so as to ensure the achievement of performance targets, leading market share and steady growth. After the launch of Hansoh Xinfu (flumatinib mesylate) and Fulaimei (polyethylene glycol loxenatide for injection), the Company has strengthened its professional academic team facilities. The existing clinical data and clinical experience of the Company has been highly recognized by clinical experts. Meanwhile, the Company cooperated with professional institutions to carry out postmarketing clinical research projects and accumulate more sufficient clinic-based evidence. The Company will subsequently organize and expand the chronic disease management to help patients improve their disease course management. Prospects: Given the acceleration of population aging in China and the continuously growing income level of Chinese residents, there is a rapid increase in health awareness and medical demand from the general public in China, leading to a growth in healthcare expenditure year by year. Cost control serves as an important initiative in the PRC medical reform. The scheme for centralized tendering with minimum procurement quantities of drugs fully implemented last year has a far-reaching impact on the development of the PRC pharmaceutical industry, which not only imposes pressure on pharmaceutical manufacturers to reduce prices, but also accelerates the process of industry differentiation and integration, promoting the sound and sustainable development of the industry. In the past few years, the PRC government has been continuously increasing medical investment in major diseases. In 2018, the PRC government held special negotiations on the inclusion of selected oncology drugs into the NRDL. In 2019, the PRC government carried out the largest negotiation on the inclusion of exclusive and patented drugs into the NRDL since the establishment of the Group’s medical insurance system, and introduced policies to support the development of medicines for chronic diseases including diabetes and hypertension, rare diseases and children, so as to meet the people’s profound need for healthy life this year. Meanwhile, the establishment of dynamic adjustment mechanism of medical insurance and the implementation of a series of supporting measures, such as speeding up the review by the drug administration department, ensure the realization of objectives of medical reform policy. In the PRC pharmaceutical market with huge potential, the industry reform brings both opportunities and challenges to the development of pharmaceutical manufacturers, therefore the manufacturers’ comprehensive competitiveness is critical to their future development. In the future, the Group will continue to enhance the Group’s core competitiveness in, among others, the fields of R&D, sales and production. The management of the Group is confident that, with the Group’s strong competitive positioning of its innovative products, its strong product pipeline and its proven R&D capabilities, the Group is well positioned to enter a new phase of rapid growth.

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