Inventory: New drugs approved by the NMPA in 2022

In recent years, under the accelerated marketing registration procedures of drugs such as special approval, breakthrough therapy drugs, conditional approval, and priority review and approval, new drugs at home and abroad have rapidly entered the Chinese market.

Looking back, in 2022, China's National Medical Products Administration (NMPA) approved the marketing of 18 Class 1 innovative drugs, including 14 domestic Class 1 new drugs and 4 imported Class 1 new drugs; More than half (10/18) were approved expeditedly through priority reviews.

In addition, through the linkage of research and review, NMPA conditionally approved the conditional listing of China's first recombinant new coronavirus protein vaccine, the first domestic oral small molecule drug to add new crown virus treatment indications, and the import of two small molecule new crown oral drugs.

The rise of domestic innovative drugs is accelerating

Analyzing the 18 innovative drugs approved by the NMPA in 2022, it can be found that although the number of innovative drugs approved in 2021 (43 models, 41 domestically produced and 2 imported) has decreased, there are some potential First in class and Best in class products, which have important clinical significance, such as Akeso's world's first PD-1/CTLA-4 bispecific antibody cardunilimab, Hua Medicine is the world's first glucokinase activator (GKA) drug dogliatin.

The world's first CRLA-4/PD-1 dual antibody: cardunilimab

Cardunilimab (trade name: Kaitanil) is a bispecific antibody PD-1/CTLA-4, a new tumor immunotherapy drug independently developed by Akeso. On June 29, 2022, the NMPA conditionally approved the marketing of cardunilimab injection for the treatment of patients with relapsed or metastatic cervical cancer who had previously failed platinum-containing chemotherapy. This is the world's first approved tumor dual immune checkpoint inhibitor biantibody, and the first immunotherapy drug approved for advanced cervical cancer.

Cardunilimab is a human tetrameric bispecific antibody developed based on Akeso's proprietary Tetrabody platform technology, which can simultaneously target two validated immune checkpoint molecules. Phase II clinical trials showed that relapsed or metastatic cervical cancer with cardunilimab monotherapy failed platinum-containing chemotherapy, regardless of the patient's PD-L1 status, the ORR of 2/3 line of cardunilim monotherapy reached 33.0% and CR reached 12%; The ORR of PD-L1+ patients (CPS≥1) was as high as 43.8%.

It is worth mentioning that in December 2022, Akeso granted Summit Therapeutics the exclusive license rights of another Evosius (AK112) in the United States, Canada, Europe and Japan, with a total transaction amount of US$5 billion and a down payment of up to US$500 million, setting a new record for Chinese pharmaceutical companies to enter overseas. It is reported that Ewosi is the world's first PD-1/VEGF bispecific antibody to enter phase III clinical studies.

China's first new drug for early type 2 diabetes: docagliatin

In October 2022, Hua Medicine's First in class hypoglycemic drug dorzagliatin (trade name: Hua Tangning) was approved for marketing to improve blood sugar control in adult patients with type 2 diabetes.

Docagliatin is the world's first approved glucokinase initiator (GKA) drug, the first original innovative drug with a new mechanism in the field of diabetes in the past decade, and the first global innovative drug for type 2 diabetes in China. The drug acts on glucokinase targets in pancreatic islets, intestinal endocrine cells and glucose storage and output organs such as the liver to improve blood glucose homeostasis disorders in patients with type 2 diabetes.

Docgliatin can be used alone or in combination with metformin to achieve complementary mechanisms, covering the complex multiple mechanisms of T2DM more comprehensively, and when metformin hydrochloride alone is poorly controlled by blood glucose, the two can be used in combination with diet and exercise to improve blood glucose control in adult patients with type 2 diabetes.

Tumor, anti-infection, metabolic...

Innovative drug research and development is blooming

From the perspective of therapeutic areas, the largest number of new anti-tumor drugs (7, 39%), endocrinology and metabolism, autoimmunity, nervous system, digestive system, cardiovascular, anti-infection and other disease areas will also usher in innovative therapies in 2022.

In 2022, 7 new anti-tumor drugs will be approved for marketing in China, including 3 small molecule drugs: revilumide tablets, limplisept tablets, toluenesulfonamide injection, 3 immune checkpoint inhibitors: serplulimab, putelimab injection and cartunilimab, and 1 traditional Chinese medicine: icariin softgel.

China's cancer burden is heavy, the number of new cancers and deaths every year ranks first in the world, and the tumor treatment market is huge. The launch of these new drugs provides new treatment options for cancer patients in China.

From the perspective of specific product types, tumor immunotherapy has gradually come to the stage, and even to the center of the stage.

In 2022, three PD-1 target new drugs were approved, including Henlius' PD-1 monoclonal antibody serplulimab, Lepu Biologics' putelimab and Akeso's PD-1/CTLA-4 dual antibody cardunilimab.

Up to now, there are 15 PD-1/PD-L1 antibodies on the domestic market, including 14 monoclonal antibodies and 1 bispecific antibody, of which 11 are domestic new drugs.

In addition to immunotherapy, 3 small molecule anti-tumor therapies were approved for marketing in 2022.

Revilumide tablets are a second-generation androgen receptor (AR) inhibitor developed by Hengrui Pharmaceutical for metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden.

Linplisset tablets are a new generation of PI3K delta (phosphatidylinositol 3-kinase subtype δ) highly selective inhibitor developed by Yingli Pharmaceutical for adult patients with relapsed or refractory follicular lymphoma who have received at least two previous systemic treatments. Hengrui Pharmaceutical obtained its joint development rights and exclusive commercialization rights in Greater China through cooperation.

Toluenesulfonamide injection is an innovative chemical drug for solid tumors developed by Red Sun Pharmaceutical, which is the first approved chemical ablation drug injected locally through fiberoptic bronchoscopic tumors in China, and the first drug indicated to alleviate severe airway obstruction in adult patients with central non-small cell lung cancer (NSCLC), filling the gap of respiratory interventional drug treatment.

With the continuous progress of the epidemic, vaccines and small molecule oral drugs for the prevention and treatment of the new crown have once again become research and development hotspots.

In 2022, NMPA approved the conditional listing of China's first recombinant new coronavirus protein vaccine with conditions, which came from Zhifei Biotechnology. The NMPA also approved 3 small molecule drugs for the treatment of new coronavirus infection, including the first domestic new crown oral drug - azvudine, and 2 imported new crown oral drugs - Pfizer Paxlovid (nematevir tablets/ritonavir tablets combination package) and Merck's monoravir capsules (trade name: Lizory/Lagevrio).

In addition, in 2022, the NMPA approved 2 innovative therapies for diabetes (Hua Medicine's dociglaatin tablets and Bayer's fenerone tablets), the first potassium ion competitive acid blocker (P-CAB) independently developed in China (Tigolaxen tablets of Luoxin Pharmaceutical) and other new drugs in the field of multiple diseases, see Table 1 for details.

Conclusion

In recent years, with the continuous deepening of the reform of the review and approval system, China's pharmaceutical industry has achieved high-quality development.

As far as 2022 is concerned, although the number of new drugs approved by NMPA is not as good as in 2021, there are many highlights in specific products, and there are many "first" launches, bringing new treatment options for a variety of diseases.

In 2023, we look forward to more innovative drugs being approved for marketing, bringing new hope for treatment in various disease fields~