A batch of blockbuster first generic drugs are launched: CSPC, Hengrui, Haisco...
In less than ten days, a number of first imitation blockbuster listings.
CSPC's first imitation approved
On April 1, CSPC announced that the “Amphotericin B Cholesterol Sulfate Complex for Injection” developed by its subsidiary CSPC Ouyi Pharmaceutical Co., Ltd. had obtained the approval for drug registration issued by the China Food and Drug Administration. The first imitation of this variety goes on the market.
Amphotericin B is a polyene antifungal antibiotic with no drug resistance problem. It is the last line of defense for the treatment of fungal infections. It is also a powerful broad-spectrum antifungal drug. Because of its poor water solubility, early products were solubilized with sodium deoxycholate , This kind of product has high nephrotoxicity, which limits the clinical application.
Compared with the amphotericin B for injection currently used in clinical practice in China, the amphotericin B complex can significantly reduce nephrotoxicity, thereby increasing the dose and increasing the therapeutic index. The approval of the product will give more patients the opportunity to receive treatment and cure, and obtain a better survival prognosis.
In general, amphotericin B complex is suitable for a wide range of people and has a huge market potential. According to the analysis of Everbright Securities, according to the "Epidemiological Trends of Fungal Infections in China", the total number of patients with deep fungal infections in China is estimated to be 600,000 to 700,000. It is assumed that amphotericin B complex applies to 1/3 of the population, and the average person is 3 per day. The treatment cycle is 14 days, and the estimated demand is more than 8 million per year. Assuming that the company's product is priced at 500 yuan per stick and penetrates more than 40% of the applicable people, the annual sales peak of this variety is expected to exceed 1.5 billion yuan, and the market prospect is broad.
In November 2019, CSPC Ouyi's Amphotericin B Cholesterol Sulfate Complex for Injection was included in the priority review process due to urgent clinical needs and market shortages. After this approval, the market performance is worth looking forward to.
The first generic drug explosion
On March 31, the State Food and Drug Administration issued information on drug approval documents to be obtained. Among them, the new 4 types of applications for mycophenolate sodium enteric-coated tablets from Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of Hengrui Pharmaceuticals, were approved, and the first one was deemed to have passed unanimously. Sexual evaluation.
Mycophenolate sodium is an immunosuppressive agent and is clinically used to improve the compliance of kidney transplant patients receiving immunosuppressive therapy and reduce the loss of graft function due to drug side effects. The drug was originally developed by Novartis and was approved for marketing in China in 2008. It is currently a Class B medical insurance product. According to data from Meinnet.com, Novartis’s Mycophenolate sodium enteric-coated tablets sold more than 700 million yuan in China's public medical institutions in 2019, and the growth rate reached 16.33% in the first half of 2020.
According to the Insight database, only the original research company of mycophenolate sodium has been approved for listing in China. In addition, the mycophenolate sodium of Kangzhe Pharmaceutical/Biocon Limited has been reported for listing, and two companies, Chia Tai Tianqing and Huabei Pharmaceutical, have been approved for clinical use.
Its competitor, mycophenolate mofetil, currently has 32 companies with various dosage forms including capsules, dispersible tablets, tablets, injections, etc., which have been approved for listing. Among them, 5 and 1 companies have passed the consistency of capsules and tablets. Appraisal, it belongs to the potential variety of centralized procurement. In addition, clinical trials have shown that patients taking mycophenolate mofetil at the same biological effect dose can maintain a higher MPA plasma concentration and have fewer adverse reactions than patients taking mycophenolate mofetil. In short, the market prospect of the drug is worth looking forward to.
On March 29, Haisco Pharmaceutical Group Co., Ltd. issued an announcement stating that Haisco Pharmaceutical (Meishan) Co., Ltd., a wholly-owned subsidiary of Sichuan Haisco Pharmaceutical Co., Ltd. "Registration Certificate", the first imitation of the avanafil film submitted for imitation of 3 categories was approved, and it was deemed to have been reviewed.
Avanafil tablets were originally authorized by Japan's Tanabe Mitsubishi Pharmaceutical Co., Ltd. to treat male erectile dysfunction developed by VIVUS. It is currently on the market in many countries, but there is no domestic production or import. According to data from Meinnet.com, the terminal anti-ED drug market in China's public medical institutions and Chinese urban physical pharmacies exceeded 3.3 billion yuan in 2019.
In addition, according to data from the National Food and Drug Administration, several pharmaceutical companies have recently approved their products for the first time, such as Dongyang Sun Pharmaceutical’s entacapone tablets on March 25, and Chengdu Beite’s injection on March 22 Use Ampicillin Sodium, Epirubicin Hydrochloride for Injection from Hisun Pharmaceutical, etc.
It can be seen that, driven by policies and other favorable factors, in addition to innovative drugs, China's research and development in the first generic drugs has also been in full swing in recent years.
On the one hand, the original research drug has been verified for efficacy and safety, and the research and development investment, risk and cycle of the first generic drug are lower than the original research drug; on the other hand, the price of the first generic drug is generally lower than that of the original drug, which is controlled by domestic medical insurance. Under the background of accelerating the replacement of original research by generic drugs, after the first generic drugs are launched, they are expected to quickly occupy the market and have a good market performance.
Therefore, in addition to the layout of innovative drugs, the first imitation has also become the development direction of the current pharmaceutical companies. It is believed that with the approval of generic drugs by many pharmaceutical companies, the relevant drug market will usher in a round of reshuffle.
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