Our reporters Zhang Yue and Cao Xueping report from Beijing.
Recently, Hunan Sheng Pharmaceutical Co., Ltd. *** 603998SH, hereinafter referred to as "Fangsheng Pharmaceutical") announced that its wholly-owned subsidiary, Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd., withdrew its marketing authorization application for Nonitong Granules due to the need to further improve the application materials for long-term toxicity test of the product Nonitong Granules.
According to the announcement, Jianmeng Pharmaceutical previously submitted a marketing authorization application for Nolitong granules to the National Medical Products Administration (hereinafter referred to as the "State Food and Drug Administration") in January 2023 and was accepted.
According to the record of Fangsheng Pharmaceutical's recent investor relations activities, because Nonitong Granules needed to further improve the application materials for the long-term toxicity test and carry out a long-term toxicity test for a period of 6 months, but the long-term toxicity test could not be completed within 80 days of the subsidy period, the subsidiary Jianmeng Pharmaceutical submitted an application for withdrawal of the registration of Nonitong Granules.
At present, Jianmeng Pharmaceutical has started to carry out the long-term toxicity test of Nonitong granules in research institutions that meet the "Good Practice for Non-clinical Research of Drugs" (GLP), and will start the research application and registration of this product again after the completion of the test. The product is not yet on the market and will not affect the company's performance this year and next.
Regarding the relevant situation of the withdrawal of the application and the future R&D arrangements, the reporter of "China Business Daily" sent a letter to Fangsheng Pharmaceutical, and its staff said that they would convey it to the person in charge, but the reporter did not receive a reply as of press time.
It is not possible to complete the long-term poison experiment in the short term
According to the requirements for the registration classification and application materials of traditional Chinese medicine issued by the State Food and Drug Administration, innovative drugs of traditional Chinese medicine refer to new prescription preparations of traditional Chinese medicine whose prescriptions are not included in the national drug standards, drug registration standards and the Catalogue of Ancient Classic Prescriptions issued by the competent department of traditional Chinese medicine, which have clinical value and have not been marketed overseas. 11. Traditional Chinese medicine compound preparation refers to the preparation composed of multi-flavor decoction pieces and extracts under the guidance of traditional Chinese medicine theory.
According to Fangsheng Pharmaceutical's semi-annual report, during the reporting period, the company's research and development of Nonitong granules carried out traditional Chinese medicine 1The marketing application of Class 1 new drug has obtained the "Notice of Acceptance" issued by the State Food and Drug Administration, and has passed the on-site inspection of drug registration and production during the reporting period, and is in the process of drug marketing authorization review.
Fangsheng Pharmaceutical's research and development of Nonitong granules can also be traced back to ten years ago. According to the announcement of Fangsheng Pharmaceutical, in May 2014, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine was the first to launch a phase clinical trial of Nonitong granules and accept case enrollment. On April 26, 2018, the summary report of the phase clinical trial was obtained.
In May 2018, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine was the first to launch the phase clinical trial of Nonitong granules and accept case enrollment, and in December 2021, Fangsheng Pharmaceutical held a summary meeting and completed the unblinding workOn June 13, 2022, the summary report of the phase clinical trial was obtainedOn January 7, 2023, Jianmeng Pharmaceutical submitted a marketing authorization application to the State Food and Drug Administration and was accepted. The cumulative R&D expenditure of Nonitong granules is about 1928570,000 yuan.
It is understood that long-term toxicity test is an important research content of the safety evaluation of new drugs in traditional Chinese medicine, and is the main basis for judging whether a new drug can transition to clinical trial. It provides a reference basis for the dosage setting of clinical safe medication, and provides a basis for the monitoring of clinical adverse reactions and physiological and biochemical indicators, which has the characteristics of long research cycle and high cost.
According to the announcement of Fangsheng Pharmaceutical, at present, Jianmeng Pharmaceutical has started to carry out the long-term toxicity test of Non-Litong granules in research institutions that meet the "Good Practice for Non-clinical Research of Drugs" (GLP), and will start the research application and registration of this product again after the completion of the test.
Performance is under pressure
Recently, Fangsheng Pharmaceutical said on the investor interactive platform that in recent years, the macroeconomic environment has been complex and changeable, the industry policy has been deepening, the company's management has been thinking about the company's medium and long-term development plan in combination with its own resources, the company decided to implement the "naturalization" development strategy, and carried out a series of measures in 2021, such as the acquisition of Tengwangge Pharmaceutical, the divestment of Baijun Medical, and Hengxing Pharmaceutical. In the next few years, the company will earnestly implement the development strategy of "naturalization", that is, to divest non-core business, differentiate non-core business assets, return to the "one" main business, and maintain appropriate correlation with core business.
In 2021, Fangsheng Pharmaceutical will start with 17.6 billion yuan acquisition of Tengwangge Pharmaceutical, obtained a number of product approvals, including strong loquat paste (honey refining). Strong loquat paste (honey refining) is a national medical insurance class A variety, a national basic drug, and a national exclusive agent, and the sales volume of this product in 2022 will be 786940,000 bottles, a year-on-year increase of 258%.
After the merger and acquisition of Tengwangge Pharmaceutical and the divestment of Baijun Medical and Hengxing Pharmaceutical, Fangsheng Pharmaceutical's profits have increased to a certain extent in 2022. From 2020 to 2022, the revenue will be 127.9 billion yuan, 156.7 billion yuan, 179.2 billion yuan;The net profit was 63.79 million yuan, 70.04 million yuan and 28.6 billion yuan. However, at the same time, Fangsheng Pharmaceutical's sales expenses have also increased, and the company's sales expenses have increased from 4$8.3 billion to 75.5 billion yuan.
However, in terms of performance, Fangsheng Pharmaceutical is still facing some pressure. In the first three quarters of 2023, Fangsheng Pharmaceutical's revenue was 121.5 billion yuan, down 10 percent year-on-year51%, net profit 14.2 billion yuan, a year-on-year decrease of 4527%。
From 2017 to 2022, the number of innovative Chinese medicine drugs on the market was 1, 2, 2, 3, 12, and 7, respectively. Fangsheng Pharmaceutical's Pediatric Jingxing Cough Granules and Xuanqijian Bone Tablets were approved in 2019 and 2021, respectively. In terms of R&D, the company's investment in R&D has increased from 04.2 billion yuan, an increase to 07 billion yuan.
According to the announcement of Fangsheng Pharmaceutical, in terms of traditional Chinese medicine R&D project reserves, the company currently has traditional Chinese medicine R&D project reserves such as Nonitong Granules, Zhenlong Tongluo Tablets, Stomach Pain Relief Pills, Qi Yiqi Tumor Elimination Granules and Hemostasis and Pain Relief Granules. Among them, the stomach pain relief pill is currently undergoing phase III clinical trials and is expected to be declared for production in 2025. In addition, the clinical research on the indications of innovative Chinese medicine pediatric Jingxing cough granules is currently in phase II clinical trials.
Editor: Cao Xueping Proofreader: Yan Jingning).