More Than 10 Varieties Of Beite Pharmaceutical Co., Ltd. Have Been Approved Every Year Since Entering The Harvest Period Of Research And Development

Beite pharmaceutical industry has entered the harvest period, and the conformity evaluation of generic drugs in the past has ushered in a bumper harvest, and a number of independent research and development innovative drugs have also entered the clinical critical stage.

In the first half of 2020, Beite Pharmaceutical Co., Ltd. ranked among the top ten in China in the number of application consistency evaluation. As of December 31, 2020, Beite Pharmaceutical Co., Ltd. has carried out a total of 55 varieties of conformity evaluation, of which 18 have been accepted by CDE. At present, the company has more than 150 research projects, of which the clinical trial of national class 1 new drug bt-1053 is progressing smoothly, and the research and development of macromolecular biological innovative drugs has entered the "fast track".

The reason why it can enter the period of rapid development is due to the "imitative innovation" layout and continuous R & D investment of Beite pharmaceutical industry for many years. It is understood that, with innovation as the driving force for development, Beite pharmaceutical has maintained a high R & D investment, with R & D investment accounting for 11% of business revenue in 2017 to 13% in 2020, showing a trend of annual growth.

In the prospectus, Beite pharmaceutical also mentioned that it would take this A-share IPO as a new development opportunity, combine with the construction of the project invested by the raised funds, take high-end generic drugs as the cornerstone, take inhalation preparations as breakthrough, and take small and medium molecular innovative drugs as new growth points to further optimize the company's business layout.

Harvest period of development

According to the prospectus of Beite Pharmaceutical Co., Ltd., it is mainly engaged in the R & D, production and sales of high-end generic drugs, innovative drugs and API, and is a high-tech enterprise driven by innovation. At present, the company has more than 140 product specifications on sale, covering anti infection, reproductive system, cardiovascular system, blood and hematopoietic system and other sub fields. The company has more than 210 pharmaceutical products and more than 60 API product registration approval documents. It includes several first imitations or exclusive products.

In recent years, with innovation as the driving force for development, Beite pharmaceutical has maintained high R & D investment. The proportion of R & D investment in operating revenue increased year by year from 11% in 2017 to 13% in 2020. At present, the company has more than 150 research projects, covering bt-1053, bt-101 and other national class 1 new drugs, three improved new drugs such as rimazolom hydrobromide for injection and dexmedetomidine hydrochloride nasal spray, as well as high-end generic drug pipeline with rich gradient.

At the same time, Beite Pharmaceutical Co., Ltd. is also carrying out research on new drug delivery methods. Its subsidiary, privet pharmaceutical, has established inhalation preparation R & D pipelines including inhaled aerosols, inhalation powder aerosols, atomized inhalants and nasal sprays. Nearly 40 research projects are in the stage of approval and listing, with a R & D team composed of more than 890 R & D personnel, and the core backbones are all from International large pharmaceutical enterprises and well-known R & D institutions have been deeply engaged in the field of drug R & D for many years, with good educational background and profound R & D and management experience.

In the first half of 2020, Beite Pharmaceutical Co., Ltd. ranked among the top ten in China in the number of application consistency evaluation. As of December 31, 2020, Beite Pharmaceutical Co., Ltd. has carried out a total of 55 varieties of conformity evaluation, of which 18 have been accepted by CDE. In addition, in addition to actively carrying out the consistency evaluation of marketed varieties, Beite pharmaceutical also attaches great importance to the application of new drug registration classification for the varieties under study. As of December 31, 2020, 36 varieties, including oseltamivir phosphate capsules, budesonide suspension for inhalation, rivatinib mesylate capsules, dexmedetomidine hydrochloride nasal spray, have been applied for listing according to the new registration classification It has been accepted by CDE, including 15 inhaled products. When it is approved for marketing, it is deemed that they have passed the conformity evaluation. Among them, 6 varieties have not been approved for the market yet, which is expected to become the first generic drug.

In 2020, ten new generic drugs including cefdinir granules, propofol tenofovir fumarate tablets and ibuprofen injection were approved for the market, and the consistency evaluation of five varieties including finasteride tablets, ambroxol hydrochloride injection and lipoic acid injection was completed. At present, 16 product specifications of the company have passed the conformity evaluation, and 12 products are deemed to have passed the conformity evaluation, and continue to promote the conformity evaluation of generic drugs.

In addition, a number of innovative drugs independently developed by the company have entered the pre clinical critical stage, the clinical trial of bt-1053, a new class 1 drug, has progressed smoothly, and the research and development of macromolecular biological innovative drugs has also entered the "fast track" of development.

Beite Pharmaceutical Co., Ltd. is also the construction unit of the first batch of concentrated production base of small and seed drugs (short of drugs) in China, and has become the leading organization of three major consortia together with China Pharmaceutical Group and Shanghai Pharmaceutical Group. Since the outbreak of new crown pneumonia in 2020, the company has timely guaranteed the supply of epidemic prevention and control drugs, and has been included in the list of key enterprises for epidemic prevention and control in China.

Break the monopoly of multinational pharmaceutical enterprises

In order to break the long-term monopoly of China's inhaled drug market by multinational pharmaceutical enterprises, and accelerate the import substitution in the field of inhalation preparations, Beite Pharmaceutical Co., Ltd. has continuously and systematically carried out the research and development of inhalation drug delivery routes, and constructed a complete technical platform from early research and development, clinical research to industrialization, and formed inhalation aerosols, inhaled powder aerosols, aerosol inhalers and nasal sprays We also have a comprehensive R & D pipeline for inhalation preparations.

After years of continuous R & D investment, betel pharmaceutical has arranged a series of heavy breathing preparations under research, such as ipratropium bromide solution for inhalation, budesonide suspension for inhalation, dexmedetomidine hydrochloride nasal spray, budesonide formoterol inhalation aerosol, salmeterol fluticasone inhalation powder aerosol, and many of them are in the evaluation stage. The multi dosage inhaled drug delivery platform is beneficial for the company to occupy a favorable position in the competition of inhalation preparation subdivision field.

In 2020, the field of inhaled preparations of Beite Pharmaceutical Co., Ltd. has ushered in a harvest outbreak period. At present, salbutamol sulfate solution for inhalation, ipratropium bromide solution for inhalation and compound ipratropium bromide solution for inhalation have been successfully listed on the market. The first inhalation product "salbutamol sulfate solution for inhalation" was delivered and sold on December 28, 2020, and more inhalation products will be reported in the future Production.

In addition, Beite pharmaceutical has a number of generic drugs for the treatment of hypertension and other diseases, and is expected to break through the monopoly and realize domestic substitution under the background of volume purchase.

The State Council held an executive meeting on January 15, which planned to further promote the reform of centralized drug procurement with quantity, and reduce the burden of medical treatment by normalized and institutionalized measures. At the time of steady progress of centralized purchase, it is the comprehensive strength of enterprises, especially the advantages of high barrier product clusters.

For example, the application for generic marketing of valsartan amlodipine tablets (I) of Beite Pharmaceutical Co., Ltd. was approved on March 8. This product is the first new product approved for marketing by Beite this year, with the approval number of Guoyao Zhunzi h20213169.

Valsartan amlodipine is a film coated tablet, and the film coated tablets are white. For the treatment of essential hypertension, for single drug treatment can not fully control blood pressure patients. Valsartan amlodipine is the original research product of Novartis. In 2019, the total sales of valsartan amlodipine in China's public medical institutions and China's urban physical pharmacy terminals has exceeded 2 billion yuan.

In 2020, the first products approved by Beite pharmaceutical were cefdinir granules and propofol tenofovir fumarate tablets. According to the data from the Internet, in 2019, the market scale of cefdinir in China's public medical institutions exceeded 3 billion yuan, and the first cefdinir granules produced by Beite Pharmaceutical Co., Ltd. made up for the market gap; Propofol tenofovir fumarate tablets were known as "hepatitis B miracle drug", and the global sales of the original products in 2019 were nearly 500 million US dollars.

?