Progress and systematic review of consistency evaluation of generic drugs

Eight years have passed since the evaluation of the consistency of generic drugs has been carried out. The excitement, wait-and-see, loss, and rational confrontation periods of the industry have all passed away. Rethinking the issue of consistency evaluation of generic drugs requires us to think from the top-level design of the pharmaceutical industry. We look forward to the rebirth of pharmaceutical companies next year and see the leapfrog development of companies that conform to policy trends.
For companies that are still waiting to see, they need to re-learn the generic drug consistency evaluation documents, pay attention to the overall progress of the industry, determine their own industrial direction, and clarify their strategic development ideas.
Consistency evaluation, since the implementation of the policy, has been fruitful! Most of the pillar varieties of enterprises have passed the evaluation or entered the declaration stage, and the quality of domestic imitation products has continued to rise. As of November 4, the Drug Evaluation Center of the State Food and Drug Administration, CDE had a total of 1,556 acceptance numbers for consistency evaluation, involving 327 varieties and 459 companies participating. According to the statistics of an institution’s database, there are currently a total of 169 varieties passed/deemed to have passed the consistency evaluation, involving 165 pharmaceutical companies, of which 4 companies passed the consistency evaluation and the number of product regulations exceeded 20.

Qilu Pharma: 30

At present, in the application of consistency evaluation, Qilu  Pharma: takes the lead with 30 over-evaluated products. The first variety that passed the consistency evaluation was gefitinib tablets (a supplementary application approval for consistency evaluation was obtained on 2017/12); subsequently, Qilu  Pharma varieties tenofovir disoproxil fumarate tablets and terbinal hydrochloride Fen tablets, solinacine succinate tablets, olanzapine tablets, olanzapine orally disintegrating tablets, and levocetirizine hydrochloride tablets have passed the consistency evaluation.

In the consistency evaluation of Qilu  Pharma , such a fruitful harvest is inseparable from the overweight of R&D and innovation. As of October 17, Qilu  Pharma has undertaken nearly 30 major national science and technology projects. In the past 10 years, it has won 4 second-class national scientific and technological progress awards, and has ranked among the top 3 domestic pharmaceutical companies for innovation capabilities for many years. Currently, Qilu  Pharma has more than 200 new drug projects under development, of which more than 50 projects are innovative drug projects.

Fosun Pharma: 28

At present, Fosun Pharma has 28 products under evaluation, ranking second only to Qilu  Pharma (30). As of August 2, its average R&D expenditure for each over-evaluated variety has reached 7.772 million yuan. According to public information, in the first quarter report of 2019 released by Fosun Pharma, its research and development expenses were 394 million yuan, a year-on-year increase of 41.85%. With the acceleration of the consistency evaluation work, the research and development expenses invested by Fosun Pharma will continue to increase.

Thanks to continuous R&D and innovation, Fosun Pharma has recently made new progress in biomedicine and small molecule innovative drugs. Han Likang, the first domestically produced biosimilar drug, was approved in the first half of 2019. HLX02 (trastuzumab biosimilar) has been declared and accepted for production in the first half of the year. The clinical phase III reached the preset end point. The product is expected to be approved for marketing in the first half of 2020, becoming the first domestic trastuzumab biosimilar medicine. In addition, HLX11 (pertuzumab biosimilar) is about to enter the clinic, enriching the company’s HER2 breast cancer product pipeline. A number of small molecule innovative drugs have gradually entered the clinical stage, and their later development momentum has been strong.
　　

CSPC: 20

At present, CSPC has established a rich R&D pipeline. Among them, 18 small molecule innovative drugs have entered the clinical research stage and 4 are in the registered clinical stage; 13 large molecule innovative drugs have entered the clinical research stage, and 3 are in the clinical research stage. Registered clinical stage; 9 products of the new formulation are in clinical stage, 4 of which are in registered clinical stage. The products have also covered multiple therapeutic areas such as tumors, mental nerves, cardiovascular, cerebrovascular, digestion and metabolism, anti-infection, and autoimmunity. The research and development system is well established, and innovative drug products will enter the harvest period.

In the next three years, CSPC is expected to launch a number of innovative drug products, among which amphotericin B complex, CD20 monoclonal antibody, and mitoxantrone liposomes are expected to be launched in 2020; PI3K inhibitors and RANKL monoclonal antibodies , Irinotecan liposomes are expected to be on the market in 2021; DBPR108 (DPP-4), RMX1002 (EP4 receptor antagonist), long-acting GLP-1 and other products are expected to be on the market in 2022. With the launch of innovative drug products and increased volume, CSPC may have a number of blockbuster varieties with sales exceeding 1 billion in the next five years.

Huahai Pharm: 20

Huahai Pharm’s first product passed the consistency evaluation was Losartan Potassium Tablets (2017/12), and the first declared product was Irbesartan Hydrochlorothiazide Tablets (2017/8); then, Irbesartan Tablets and Fu Twenty drugs including sinopril sodium tablets, voriconazole tablets, donepezil hydrochloride tablets, valsartan tablets, risperidone tablets, nevirapine tablets, paroxetine hydrochloride tablets, and lisinopril tablets have been reviewed.

A few days ago, Huahai Pharm released its three-quarter report showing that its operating income for the first three quarters of 2019 was 4.012 billion yuan, a year-on-year increase of 4.39%; net profit was 512 million yuan, a year-on-year increase of 100.4%; net profit after deduction was 373 million yuan, a year-on-year increase of 37.2 %. As Huahai Pharm’s raw materials of Irbesartan and Losartan potassium have once again obtained the qualification for export to Europe, the future performance is generally optimistic.