In 2021, more than 30 new drugs will be listed through priority review, and oncology drugs will still be the main line of domestic innovation

Health Times reporter Zhao Mengmeng

According to the incomplete statistics of the Health Times reporter, as of December 28, 2021, at least 31 new drugs (excluding vaccines and traditional Chinese medicines) have been approved for listing through priority review. It is understood that the priority review and approval procedure applies to urgently needed clinical shortage drugs, new drugs for the prevention and treatment of major infectious diseases and rare diseases; new varieties, dosage forms and specifications of children's drugs; urgently needed vaccines and innovative vaccines.

From the perspective of the treatment field of approved products, tumors and rare diseases are the two major areas with the largest number of approved products. Among them, 13 new tumor drugs have been approved for marketing, covering non-small cell lung cancer, large B-cell lymphoma, breast cancer, hepatocellular carcinoma, gastric cancer, ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma, basal cell carcinoma, etc.

In the field of oncology, the Chinese market in 2021 harvested several significant drugs.

In June 2021, Fosun Kate's Agironse Injection was approved, and China ushered in the first CAR-T cell therapy product. Coincidentally, on the immediate September 1, WuXi Juno's Ricky Olensai injection was approved for listing, becoming the second CAR-T cell therapy product approved for marketing in China, and the first CAR-T product of Class 1 biological products in China.

Also in June, Rongchang Biological self-developed injection vidicetizumab was approved for marketing, it is worth noting that vidicetizumab is the first antibody conjugated drug independently developed in China, different from similar foreign drugs, vidicetitomab has differentiated biological characteristics, better targeting and efficacy, and better drug resistance.

In August, Rongchang Biotech reached a cooperation with Seattle Genomics, an internationally renowned biopharmaceutical company, which obtained the development and commercialization rights of Rongchang Bio's ADC new drug vidicetizumab in most overseas markets, with a price of US$2.6 billion, refreshing the overseas licensing transaction record of a single variety of Chinese pharmaceutical companies.

According to the incomplete statistics of the Health Times reporter, in the field of rare diseases, since this year, there are 10 new drugs for rare diseases approved for marketing in China, including brosoyuzumab of Concord Fermented Kirin, Α of Etibant acetate and veravosidase, Dimethyl Fumarate of Janssen, Aminopyridine of Bojian, Rossell's Risprolane oral solution powder and satlilizumab and Shelfiximab introduced by BeiGene.

Among them, a total of 5 new drugs for rare diseases have been approved for marketing through priority review. In January 2021, the brosoyomab injection of the Japanese pharmaceutical company Concord Kirin Company was approved for listing, and the brosoyuzumab injection was the first drug approved to treat X-linked hypophosphatemia, filling the gap of no drugs available in this treatment field, and the drug was included in the "second batch of clinically urgently needed overseas new drugs list".

In December of the same year, through the priority review and approval procedure, the application for the import registration of stuximab for drug injection was approved, and the drug was included in the list of the "First Batch of Clinically Urgently Needed Overseas New Drugs" due to rare diseases, which was introduced by BeiGene, and the listing application submitted in January 2021 was accepted.

Judging from the above approvals, rare disease drugs mainly rely on overseas imports. However, with the continuous introduction of incentive policies, the number of enterprises in the field of rare diseases has gradually increased in recent years.