Regulatory updates on China, November 2019

Dr. C. Benson Kuo and his team are documenting the evolving regulatory landscape in China! For general information on Education Initiatives, click hereHighlight posted on November 29th, 2019

Ban on Prescription Drugs by Mail

The Negative List of Market Access (2019 version), issued by the China National Development and Reform Commission (NDRC) on 22 November, clearly indicates that drug production and trading companies shall not directly sell prescription drugs to the public by means of mail or internet trade. The purpose is to further regulate online drug sales and strengthen industry supervision.

U.S. FDA Grants BeiGene Accelerated Approval for Brukinsa to Treat Adult Patients with Mantle Cell Lymphoma

On November 14, 2019, BeiGene announced that Brukinsa (zanubrutinib) has received accelerated approval from the United States Food and Drug Administration (FDA) as a treatment for mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy. This accelerated approval is based on a positive overall response rate (ORR). Approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

BeiGene is a Beijing-based commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer. BeiGene spent more than seven years developing Brukinsa from laboratory to commercialization. It is the first innovative anti-cancer drug independently developed by a Chinese pharmaceutical approved in the United States.

Bio-Thera gets 1st NMPA approval for Humira biosimilar

Bio-Thera Solutions, Ltd has won regulatory approval for Qletli, a biosimilar to Abbvie’s blockbuster rheumatoid arthritis treatment Humira (adalimumab). Qletli is the first Humira biosimilar approved in China and the second biosimilar approved by the China National Medical Products Administration (NMPA).

The approval of Qletli was based on the totality of evidence from a comprehensive data package supporting biosimilarity to adalimumab which includes analytical, nonclinical, pharmacokinetics, pharmacodynamics and clinical data. The Phase III clinical study met its primary endpoint showing no clinically meaningful evidence in safety, immunogenicity and efficacy compared to adalimumab. The approval of Qleti paves its entry into the world’s second-largest drug market. With Humira having lost patent protection in Europe and U.S. patents set to expire in 2023, there is increasing competition for adalimumab around the world.

New Round of National Drug Pricing Negotiation Begins

On November 11, 2019, the China National Health Security Administration (NHSA) launched a new round of National Drug Pricing Negotiation. According to the schedule, the first 128 drugs included in the scope of consideration, will enter the negotiating list. Most of these drugs are high-priced innovative or clinically urgently needed drugs.

The National Drug Pricing Negotiation will focus on cancer, rare diseases, chronic diseases, children’s drugs, first-aid rescue drugs and clinically essential drugs. Clear efficacy and safety will be the most important proof for consideration by NHSA. Also, the clinical value, economics, and health output will also determine whether there is a pharmacoeconomic value or stress on the health care fund.

Novaferon, indicated for hepatitis B, is China’s first bio-innovative drug with a completely independent intellectual patent. It was the first drug to successfully complete the negotiation process and be included in the national medical insurance reimbursement list.

Chi-Med Announces NDA Acceptance for Surufatinib in Non-Pancreatic Neuroendocrine Tumors

Hutchison China MediTech Limited (Chi-Med) announced its New Drug Application (NDA) for surufatinib for the treatment of patients with advanced non-pancreatic neuroendocrine tumors (NET) has been accepted for review by the China National Medical Products Administration. Chi-Med currently retains worldwide rights to surufatinib.

The NDA is supported by data from the successful SANET-ep study, a Phase III study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic patients in China for which there is no effective therapy. The positive results of this trial were highlighted in a presentation at the 2019 European Society for Medical Oncology Congress on September 29, 2019.Surufatinib is being tested in multiple studies for solid tumors in China, the U.S. and Europe, both as a monotherapy and in combination with immunotherapies.

Alzheimer’s Drug Shows Promise

Shanghai-based Green Valley Pharmaceuticals has developed and been given conditional approval by the China National Medical Products Administration for Oligomannate, an oral Alzheimer’s drug that could help cognitive function for patients with a mild form of the disease. Green Valley said that Oligomannate would be released in China by the end of 2019. The company will then carry out phase three trials abroad in 2020 and later seek approval to market the drug in the U.S. and Europe. The new drug will be the first approved in 17 years to treat the degenerative disease.

Oligomannate is made from extracts of brown algae as raw material and works by suppressing certain bacteria in the gut that causes neural degeneration and inflammation in the brain. It was jointly developed by the Chinese Academy of Sciences’ Shanghai Institute of Materia Medica, Green Valley and Ocean University. During trials, it was tested on 818 people, but doctors warn it may not cure patients with advanced cases of Alzheimer’s.

China bans online e-cigarette sales

According to a statement released by the China State Tobacco Monopoly Administration and State Administration for Market Regulation, producers and sellers of electronic cigarettes are required to shut down websites and other online portals, as well as suspend related advertising. Also, e-commerce platforms are required to remove retailers selling e-cigarettes and pull their merchandise. The ban takes effect immediately.

Last August, China barred the sale of e-cigarettes to people less than 18 years of age, but they are still available across the country’s bustling marketplace where age verification is hard to implement. In China, the market for electronic cigarettes is rife with substandard products. Further, vaping businesses tend to target young people with advertising campaigns, misleading them by falsely claiming their products are harmless and effective for quitting tobacco use. With over 300 million smokers in China, the Chinese government called for stepping up closer supervision over the entire smoking industry.

Medical Device
China International Import Expo – Medical Equipment and Health Care Products Exhibition

The second China International Import Expo, held in Shanghai from November 5 to 10, included a medical equipment and health care products exhibition area to introduce import pharmaceuticals, medical equipment and devices, health care products, senior care and rehabilitation services, and pharmaceutical machinery. Nearly 20 pharmaceuticals companies, 80 medical equipment and services companies, 130 health care products companies, and senior care and rehabilitation services companies participated.

Due to a growing awareness of health and a rapidly ageing population in China, medical demand and the need for quality products and services from overseas is expected to continue to rise and contribute to the development of the national health industry.