On February 3, the result of the fourth batch of national volume-based procurement (VBP) was announced, and the competition results of the antidepressant drug duloxetine were settled. The results show that Qingdao Baheal Pharmaceutical Co., Ltd (Baheal Pharma), a subsidiary of Baheal Pharmaceutical Group, won the competition with the price of RMB 8.25 per box for Duloxetine Hydrochloride Enteric Capsules Nishu (20mg*14 capsules).
Depression is a common psychiatric disorder, with 350 million people worldwide estimated to suffer from it. In China, the prevalence rate is 2.1%. Duloxetine is mainly used to treat depression and generalized anxiety disorder, especially for depressed patients with pain and other physical symptoms.
Duloxetine is widely accepted clinically because of its good tolerability, significant and rapid efficacy, ease of administration, and few side effects. Data from menet.com. shows that in recent years, the growth rate of sales of duloxetine capsules in Chinese urban public hospitals, county-level public hospitals, urban community centers and township health center terminals has remained above 15%, with more than 600 million yuan in 2019 and 24.37% year-on-year growth in the first half of 2020.
Zheng Aiju Baheal Pharma General Manager introduced, Baheal Pharma's Nish, this selected collection of Duloxetine hydrochloride enteric capsules, uses enteric micro-pill coating process (including drug layer, isolation layer, enteric layer), in which the production process is complex, and the drug formulation technology has a big challenge.
"Micro-pills have large specific surface area, which can effectively improve bioavailability, and each micro-pill is an independent drug release unit with constant slow release effect, which is safer and more effective. In addition, micro-pills are not affected by gastrointestinal peristalsis, reducing irritation and individual differences in pharmacokinetics." Zheng Aiju said that Baheal Pharma's duloxetine capsules received marketing approval from FDA in April 2019 and NMPA in December 2020, which is considered to have passed the "consistency evaluation" - a high-quality domestic drug in terms of quality The quality, efficacy and safety of domestic drugs are consistent with those of the branded drugs.
According to the introduction, Baheal Pharma mainly focuses on the research and development, production and sales of osmosis pump, micro-pill coating, skeleton tablets and other high-end slow and controlled release formulations, with zero defects through the FDA certification, all products to achieve the same report and sales in the United States and China, common line production at home and abroad, laying a solid foundation for the internationalization of formulations. Baheal Pharma's internationalization of high-end oral solid formulation research products have five projects supported by the "Thirteenth Five-Year Plan" National Major New Drug Creation Special Project, which means that its high-end generic drug development and production capacity has been in the leading position in the industry.
Previously, metformin hydrochloride extended-release tablets (III) Nida and celecoxib capsules Niqi have been approved by FDA and NMPA for marketing, among which celecoxib capsules Niqi has been selected in the third batch of VBP. Baheal Pharma has established 13 high-end generic drugs, and will continue to develop and market high-end generic drugs that meet the therapeutic equivalence in the future. Baheal Pharma will actively lay out the international market to provide China and other countries in the world with pharmaceutical preparations of excellent quality.
"Baheal Made Duloxetine, has achieved the same report and sale in China and the United States, and this time, it has been selected for VBP, which will provide patients with international quality antidepressants and bring new choices for depression and anxiety patients.
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