In 2021, NMPA-approved innovative drugs hit a record high of 47, says a June report published by the CDE.
Review and approval times were accelerated as well, especially for imported drugs with urgent clinical needs. The development of COVID-19 vaccines and therapies, pediatric drugs and treatments for rare diseases and cancers is being encouraged.
Additionally, 87 technical guidelines were released for the implementation of ICH, aligning China’s requirements with internal standards.
Innovative drug approvals continue to grow
In 2021, 1,628 registration applications (878 varieties) for innovative drugs were approved/recommended for approval, representing a year-on-year increase of 67.32%.
Among them, 1,029 were innovative chemical drugs (463 varieties), up 44.32%. 560 were innovative biological products (376 varieties), up 141.38%.
In terms of application categories, there were 1559 INDs (831 varieties), up 65.32% year-on-year, and 69 NDAs (47 varieties), up 130.00% year-on-year.
1261 applications (684 varieties) were manufactured in China, a year-on-year increase of 60.84%. 367 applications (194 varieties) were manufactured overseas, a year-on-year increase of 94.18%.
Expedited approval through four accelerated review & approval pathways
The CDE has defined four accelerated drug review & approval pathways. These are breakthrough therapy, conditional approval, priority review & approval and special approval. One application can follow multiple pathways.
1. Breakthrough therapy
In 2021, 53 (41 varieties) out of 263 applications were granted breakthrough therapy status, with indications including COVID-19, non-small cell lung cancer and ovarian cancer. Five NDAs with breakthrough therapy status were recommended for approval last year.
2. Conditional approval
Of the 323 NDAs recommend for approval, 60 (38 varieties) were granted conditional approval, accounting for 18.58%.
3. Priority review & approval
115 registration applications (69 varieties) were granted priority review & approval status. 41 (35.65%) of them were also granted conditional approval. 34 were for pediatric drugs, accounting for 29.70%.
The CDE’s priority reviews were focused on innovative drugs with clinical advantages, pediatric drugs and drugs for rare diseases.
4. Special approval
81 registration applications for COVID-19 vaccines and treatments were granted special approval status.
12 INDs and five BLAs for COVID-19 vaccines are recommended for approval, including four inactivated vaccines and one recombinant adenovirus type-5 vector vaccine.
15 INDs for COVID-19 treatments gained approval. Four of them were for small molecular antiviral drugs. Nine were for neutralizing antibodies.
Additionally, five NDA/BLAs for COVID-19 treatments were recommended for approval, including Brii’s antibody combination.
Several important new drugs were approved for market
Amubarvimab (BRII-196) and Romlusevimab (BRII-198), developed by Brii Biosciences, are the first SARS-CoV-2 virus-neutralizing monoclonal antibody combination therapy drugs approved in China with independent intellectual property rights (IPRs).
Five imported drugs for rare diseases gained approval as well. Burosumab for X-linked hypophosphatemia (XLH), icatibant for hereditary angioedema (HAE), eftrenonacog alfa for hemophilia B (congenital factor IX deficiency), siltuximab for multicentric Castleman Disease (MCD), and ofatumumab for relapsing multiple sclerosis (RMS).
Five pediatric drugs gained approval as well, including risdiplam powder for oral solution for spinal muscular atrophy (SMA), a rare pediatric disease; dinutuximab beta injection for neuroblastoma; two modified new drugs for special dosage forms; and chemotherapy drug cisplatin.
Anti-tumor drugs gained the most approvals with a tally of 13. Two CD19-targeted CAR T-cell products, axicabtagene ciloleucel and relmacabtagene autoleucel, became the first two CAR-T therapies to land in China. Some key home-grown anti-tumor drugs like RemeGen’s HER2 ADC disitamab vedotin were also greenlighted by the NMPA.
Download the full report here: The 2021 Drug Review Annual Report.
(Edited by Justin Fischer)