CSPC's 20 varieties have been evaluated and 8 heavy ones have been approved

Release date: 2020-01-10 Views: 0

Source: Minnet  

In the past year of 2019, 14 varieties of CSPC passed the consistency evaluation, and 20 varieties have been evaluated; 8 blockbuster generic drugs have been approved for marketing, and clopidogrel has successfully won the bidding; multiple anti-tumor drug development Obtained clinical approval, L-Amlodipine maleate enters the US market; anti-tumor innovative drugs take the banner of performance growth ... Entering 2020, the highlight of the pharmaceutical industry-the second batch of procurement with volume is about to open, CSPC Group The performance of the five varieties collected in the collective harvesting is again remarkable.

Anti Parkinson's drug first review! 20 varieties of screens

A few days ago, Sun Yat-Sen Group's Sunitinib Malate Capsules and Praxox Hydrochloride Tablets were approved for marketing simultaneously, and they were deemed to have passed the consistency evaluation. Sunitinib malate capsules are the first domestic generics, and Praxox hydrochloride is the second domestic generic drug approved. It is worth noting that Praxox hydrochloride is the first anti-Parkinson's disease drug in China, which has further enriched CSPC's product line.

2019 is the peak of over-assessment of CSPC's consistency evaluation.In 2018, CSPC's amoxicillin capsules, azithromycin tablets, captopril tablets, tramadol hydrochloride tablets, metformin hydrochloride tablets, and paclitaxel (white for injection) 6 varieties including protein-binding type) passed the consistency evaluation. In 2019, CSPC will add 14 more evaluated varieties. data shows that up to now, a total of 20 varieties of CSPC have passed the consistency evaluation, of which ibuprofen tablets, ranitidine hydrochloride capsules, cefadroxil hydrochloride tablets, pramipexole hydrochloride tablets, and tramadol hydrochloride tablets 6 varieties of sunitinib malate capsules are exclusive reviews.

Of the 20 evaluated varieties, 7 are systemic antibacterial drugs involving azithromycin, clindamycin, cephalosporins, and amoxicillin. It can be seen that CSPC attaches importance to the consistency evaluation of antibiotics. According to the data from, the sales of antibacterials for systemic use in terminals in China's urban public hospitals, county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) in 2018 were 158.9 billion yuan. The evaluation will help the company's products to consolidate the market.

CSPC Group evaluates varieties through consistency

Clopidogrel is harvested at low prices, 5 major varieties are ready

With the approval of sunitinib malate capsules and pramipexole hydrochloride tablets, eight varieties of CSPC have been approved for production since 2019. Previously approved varieties were dronedarone, glutathione, metformin, ticagrelor, clopidogrel, and ambroxol.

It is worth noting that although the registered type of CSPC's clopidogrel hydrogen sulfate tablets is the imitation type 6, it was reviewed according to the new classification, approved for production and deemed to have passed the consistency evaluation. In the "4 + 7" expansion, the successful bidders were 3 CSPC, Sanofi and Lepu Pharmaceuticals. The lowest price was RMB 2.44 per tablet in Encun of CSPC. In the face of volume-based procurement with consistency evaluation as the threshold, CSPC was fortunate to use the new classification review to achieve overtaking in the curve and win the bidding. Under the situation of “3 over-rated + original research”, Xinlitai The offer is higher and regretful to be out.

8 varieties approved by CSPC in 2019

The second batch of purchased varieties will be opened for bidding on January 17. This time, five varieties of CSPC were selected, namely azithromycin tablets, cephalexin capsules, amoxicillin capsules, clindamycin hydrochloride capsules, and injections. Paclitaxel (albumin-bound).

The consistency evaluation database shows that of the 5 second batches of collected varieties that have been evaluated by CSPC, azithromycin tablets and paclitaxel (albumin-binding) for injection have been evaluated by 2 and 3 companies, respectively, and cefalexin Capsules, clindamycin hydrochloride capsules, and amoxicillin capsules have been evaluated by five, six, and nine companies, and the competition is particularly fierce. On the day of the bid opening on January 17, how will CSPC release its brand? We will wait and see!

Competition pattern of CSPC's second batch of centralized mining varieties

R & D successes spread frequently! Innovative medicine takes the banner of performance

As a leading domestic comprehensive pharmaceutical company, CSPC is actively transforming the research and development of innovative drugs and exploring overseas markets as the pharmaceutical industry is reshuffled. Clinical trials of new drugs in the United States and Australia continue to progress, and L-Amlodipine Maleate has become the first Chinese innovative drug to be fully approved by the FDA.

In 2019, CSPC's success in the development of new drugs has been reported frequently. Several new anti-tumor drugs have obtained clinical approval, including anti-tumor nano-drugs (epirubicin hydrochloride liposome injection) and new target anti-tumor drugs (SYHA1807). And SYHA1801) breast cancer drugs (paclitaxel cationic liposomes for injection), intrahepatic bile duct cancer and urothelial cell cancer drugs (SYHA1803) malignant tumor ascites drugs (recombinant anti-EpCAM and CD3 human-mouse chimeric bispecific antibodies for injection) ), Bone cancer drugs (ALMB-0168), etc.

New drug research and development announcement issued by CSPC in 2019

In recent years, CSPC's performance has continued to grow rapidly, with both revenue and net profit showing a considerable upward trend. The sales of anti-tumor drug portfolios have maintained strong growth, with 208% growth in 2019Q1, 194.2% growth in 2019H1, and 170.7% growth in 2019Q3. The strong sales growth has pushed the company to increase investment in drug research and development. At present, the Group has about 300 innovative drug product projects, of which 30 new molecular targets are under development, 40 small molecular new drugs, and over 70 new types of original drugs.

At the time when the pharmaceutical industry is undergoing drastic changes, CSPC is also continuously adjusting its R & D layout for new drugs. Recently, CSPC has “broken up” with two innovative pharmaceutical companies, and terminated the cooperation with Junshi Biotechnology in the research and development and commercialization of breast cancer drugs to avoid clinical research with another group of anti-PD-1 monoclonal antibodies in development. Potential conflicts that may be caused by commercialization in the future; the commercialization agreement previously reached with the research and development of the new drug SCT400 from China Cell is facing termination. It is reported that SCT400 is an anti-CD20 monoclonal antibody for injection and is used to treat non-Hodgkin lymphoma. There are many uncertainties in the research and development of new drugs, and the reasons for the termination of commercialization cooperation are various. The purpose of CSPC's move is undoubtedly to improve the strategic layout of the group's research and development and improve innovation efficiency.

Data source: Minet website, public company announcement

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