he number of new drug approvals in China set a new record high in 2021. A total of 61 new drugs were approved by the National Medical Products Administration (NMPA), up from 46 in 2020. “New drug” is defined in this article as new chemical drugs or new biological products approved for the first time in China, excluding any new indications, new dosage forms, or new combination of approved drugs.

Under the current Chinese regulatory framework, a Category 1 new drug is any product that has not been approved in any country when the NDA is submitted in China (i.e., the so-called global new drug). In 2021, the NMPA CDE approved 29 Category 1 drugs, 27 of which were developed by local companies. This was a notable increase compared with 2020 (16 Category 1 drugs approved) and 2019 (12 Category 1 drugs approved), providing another indication of the progress of local new drug research and development.

By therapeutic area, 27 anticancer drugs were approved, accounting for the largest proportion (44%) of approvals. In November 2021, against the backdrop of the highly active and competitive landscape of oncology drug research and development, the CDE issued its Guideline for Clinical R&D of Anti-tumor Drugs Guided by Clinical Value, which emphasized the importance of patient centricity in the development of new oncology drugs to develop more effective, safer, or more convenient treatments based on real clinical value.

Among the highlights of 2021:

One of the remarkable events was the 2021 approval of two CAR-T products, which signaled that CAR-T treatment has finally entered the stage of commercialization in China. In June, the NMPA approved the first cell therapy in China, axicabtagene ciloleucel, for the treatment of recurrent or refractory large B-cell lymphoma after previous second-line or more systemic treatment. In September 2021, the global new drug and second CAR-T product, relmacabtagene autoleucel injection, was approved.

In 2021, the NMPA granted 15 conditional approvals, of which 12 were given to local products. It seemed that more local new drugs were approved through the conditional approval pathway, i.e., in many cases, the NDA was supported by phase 2 clinical evidence. This was different from previous years, when most of the conditional approvals were granted to imported drugs mainly to solve urgent medical needs.

The NMPA approved 12 rare disease drugs in 2021. Encouraging rare disease drug development has been one of the priorities of NMPA and CDE. To this end, the CDE issued a new guideline on this topic to further guide the industry in clinical development of rare disease drugs.

Simultaneous global development of innovative drugs has also been encouraged by the NMPA in recent years. China’s participation in multiregional clinical trials (MRCTs) offers the potential to greatly accelerate Chinese patients’ access to innovative therapies. One of the 2021 approvals, risdiplam, may serve as an example. By including China in the global clinical trial programs, the sponsor was able to file the NDA in China before the first regulatory approval worldwide, i.e., so-called Category 1 new drug in China, and received NDA approval several months after US approval, significantly shortening the drug lag.

Overall, the new drug approvals in 2021 reflect the continued positive progress of the regulatory system in China, supportive of innovation and high regulatory standards. Local biopharmaceutical companies have benefited from the regulatory reform and achieved significant outcomes.

New Drugs approved by NMPA in 2021