In drug development, certain drugs are classified as new molecular entities (NMEs) during the review process by regulatory agencies. These NMEs contain active moieties that have yet to be approved. Once approved, these products will become either a single-ingredient drug or part of a combination product. NMEs that eventually become approved drugs will provide important new therapies for patients. 

For these products to be authorized for use in treating diseases in patients, they must go through a stringent regulatory process before it is launched into the market. Globally, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are regulatory systems recognized as key launch pads for innovative medicines worldwide. China also has its version of a regulatory system for drugs and medical devices known as the National Medical Products Administration (NMPA).

Novel Drug approvals in 2022

The FDA’s Centre for Drug Evaluation and Research (CDER) approves novel drugs. Last year, CDER approved a total of 37 novel drugs, which include both NMEs and new therapeutic biological products. This data represents the lowest number of newly approved drugs by the FDA since 2016. 

In 2022, both novel drug approvals and drugs approved in new settings focused on target diseases and conditions such as infectious diseases, neurological conditions, heart, blood, kidney, and endocrine diseases, autoimmune, inflammatory, and lung conditions, as well as different types of common cancers like lung cancer, prostate cancer, and types of breast cancer. Patients with rare diseases were also included in the mix. 20 of 37 novel drug approvals by the FDA in 2022 were catered to new therapies for rare diseases. 

The EMA also had its fair share of new drugs in 2022. The agency’s Committee for Medicinal Products for Human Use (CHMP) issued approvals for a total of 49 new drugs that, includes therapeutic biologics and vaccines. Rare diseases took center stage in last year’s round of approvals for the CHMP, with 23 out of 49 new drug approvals specifically for the treatment of rare diseases.  

As for the NMPA, drug approvals for 2022 were unique, with the greatest number of new Traditional Chinese Medicine (TCM) drugs approved in 5 years. The NMPA approved 12 new TCM products in 2022, announced during the National Conference of Traditional Chinese Medicine Scientific Supervision held in Beijing. These new TCM drugs focus on treating respiratory and digestive diseases. The administration has also ramped up its process to ensure that applicants perform stringent tests and that all undergo randomized, double-blind, placebo-controlled clinical trials before being approved. 

Innovative new drugs often mean the possibility of new treatments for patients in critical need. NME approvals by the FDA and EMA tend to come from companies within the US or European Union, but some innovations in the past years have also been from China. Next, we shall take a look at drugs produced by Chinese companies that are projected to be approved in the global market.

Approval of Chinese drug potentials in the global market

Clarivate’s 2022 report on Drugs to Watch lists drugs that have the potential to be launched as blockbusters in the coming year. Within the list is a drug that can potentially treat non-small-cell lung cancer and colorectal cancer developed by China-based biotechnology companies Zai Lab and MIRATI Therapeutics. The drug known as adagrasib is pending approval by the FDA and EMA. The report by Clarivate also forecasts a US$ 1.23 billion in sales from adagrasib in 2026.

In the latest version of the Clarivate Drugs to Watch report released in early 2023, the data analysis company identified nine drugs that have the potential to achieve US$ 1 billion blockbuster status in China by 2030. Out of the nine, eight are oncology drugs that will help alleviate the approximately 3 million cancer-related deaths in China in 2022. Five of the nine drugs in this list have also received approval from the FDA and EMA. 

Some TCM drugs also have the potential to receive approval in the near future. Known as Compound Danshen Dripping Pill or Cardiotonic Pill, the product is known to help treat angina and coronary heart disease. It has completed Phase II clinical trials and moved on the FDA's Phase III clinical trial investigations. This could be the first TCM drug to be approved by the FDA. 

One drug that could be approved by the EMA is an oncology drug known as toripalimab by Junshi Biosciences. This drug can be combined with other drugs such as cisplatin, gemcitabine, and paclitaxel as first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma or esophageal squamous cell carcinoma. Surufatinib is another oncology drug that could be in line for approval by the EMA. It is currently being validated by the EMA for use in treating advanced neuroendocrine tumors. The marketing authorization application was submitted by the Chinese company HUTCHMED in 2021.

With healthcare reforms under Healthy China 2030, emphasis is placed on reducing the burden of cancer in China. In the coming years, we could see a steady rise in oncology drugs from Chinese biotech companies. 

About the Author

Deborah Seah, Science Writer

Deborah Seah is a contributing writer for a column on PharmaSources.com, Discovering Biotechnology. The column explores innovative technologies in the world of biotech and evaluates its impact on our future. She is also an editor for a monthly science and technology magazine, Asia-Pacific Biotech News.

Prior to her career in writing she worked as a research associate at a plant genetics laboratory of a multinational agriculture company. Following that she also had experience in a medical diagnostics start-up as a medical technologist.