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华领医药(02552)公布2023年业绩:研发开支约1.72亿元 积极推进第二代GKA海外市场布局

Hualing Pharmaceutical (02552) announces 2023 results: R&D expenses of about 172 million yuan to actively promote the overseas market layout of second-generation GKA

Zhitong Finance ·  Mar 28 09:14

On March 28, Hualing Pharmaceutical (02552) announced its 2023 results

The Zhitong Finance App learned that on March 28, Hualing Pharmaceutical (02552) announced its 2023 results. During the reporting period, the company achieved landmark results in comprehensively promoting the commercialization of doglitin, and doglitin was successfully included in the national medical insurance drug catalogue. The company has reached several milestones related to the development of doglitin and received a non-refundable milestone payment of RMB 800 million. At the same time, the company is also actively promoting the layout of second-generation glucokinase activators (second-generation GKA) in overseas markets. At the end of last year, it submitted an experimental new drug (IND) application to the US Food and Drug Administration (FDA). During the reporting period, the company's total expenditure was approximately RMB 383.3 million, of which R&D expenditure was approximately RMB 171.5 billion. As of 31 December 2023, Hualing Pharmaceutical Bank's balance and cash were approximately RMB 1,460.8 billion.

In terms of R&D and operation, Hualing Pharmaceutical submitted its second-generation GKA experimental new drug (IND) application to the FDA at the end of 2023 and was accepted to begin phase 1 clinical trials. At the same time, Hualing Pharmaceutical is carrying out research and development plans for new indications of dogliatetin, and has submitted patent applications to prevent the development of diabetes and memory impairment.

Looking ahead, Hualing Pharmaceutical anticipates that sales of dogliastine will increase after it is included in the national medical insurance drug catalogue, and progress will be made in new indications in combination with existing treatments and fixed dose combinations of doglitin and other oral antidiabetic drugs (OAD). The company will continue to optimize the core technology for allosteric regulation of important physiological protein targets and promote research on negative glucokinase allosteric modulators and metabolic glutamate receptor negative allosteric modulators. In addition, the company is also developing personalized diabetes diagnosis and treatment technology. Its algorithms can help doctors improve patient management.

In terms of production capacity, Hualing Pharmaceutical is cooperating with production partners and expanding production capacity of doglitin to ensure the expected demand brought about by a sharp increase in sales in 2024. The total investment for commercial drug production and capacity expansion in 2023 and 2024 is estimated at RMB 400 million.

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