New Drug Approvals in China in 2019

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New Drug Approvals in China in 2019

Xu Wang
Novo Nordisk (China) Pharmaceuticals Co., Ltd.

Yuanyuan Diao
BeiGene, Ltd.

n 2019, China’s National Medical Products Administration (NMPA) granted marketing approvals to 34 new chemical drugs and 19 biological products. Among the approvals, oncology drugs, anti-inflammatory drugs, and drugs for the immune system are the top three therapeutic areas.

In this article, “new drugs” refer to the innovative chemical and biological products approved for the first time in China and to drugs already approved for marketing outside China but approved for the first time in China.

Number of Innovative Drug Approvals on Rise

The NMPA defines Category 1 innovative drugs as drugs not approved anywhere in world. In 2019, 12 of the 53 new drug approvals were Category 1 innovative drugs, including eight chemical drugs and four biologics. All but one were developed by local Chinese pharmaceutical and biotechnology companies. The imported one was Dacomitinib, as an imported Category 1 product. Dacomitinib, developed simultaneously both in China and abroad, was approved by the US FDA in September 2018 and by China’s NMPA in May 2019.

Comparing the number of Category 1 drugs approved over the last five years, Figure 1 shows that there were only a few approvals between 2015 and 2017. New Drug Applications of Category 1 innovative drugs began to increase in 2017, with 11 filed in that year. The number of Category 1 approvals increased substantially in 2018 and reached a new record in 2019. This is an early sign of initial achievements in the local Chinese pharmaceutical industry’s R&D efforts in novel drug discovery and development, particularly propelled by a series of government policies encouraging innovation in recent years. It is expected that more innovative drugs will be approved and potential breakthroughs may emerge in China in the near future.

Figure 1. Approval of Category 1 Innovative Products 2015-2019
Source: Insight China Pharma Data

All Category 1 innovative drugs except one influenza vaccine (split virion, a prophylactic biological product) were eligible for priority review. The median approval time of these 12 drugs was 17 months, with 12 months being the shortest. The average time for submitting the supplemental information requested during review was about three months. Excluding this additional time for supplement submissions, even the shortest review time of 12 months only matched the timeline of regular approval, which is 200 working days, as defined in the newly released updated version of the “Drug Registration Regulation.” The updated regulation will become effective on July 1, 2020. According to the updated regulation, “priority review should be completed in 130 working days.” As such, we expect that the priority review will be further accelerated in the near future.

The 12 Category 1 innovative drugs consisted of eight chemicals and four biologics (two therapeutic and two prophylactic vaccines). Details are shown in Table 1.

Table 1. Summary of Category 1 New Products Approved in 2019

Forty-one (41) imported new drugs (chemical drugs and biologics) were approved in 2019. Notably, 30 of them were given priority review and 16 were on the list of Drugs for Urgent Clinical Needs.

Approvals of Drugs for Urgent Clinical Needs

To reduce the drug lag and improve access to certain drugs approved in the US, Europe, and Japan in the last ten years that are deemed important for urgent clinical needs, the NMPA issued two lists of such drugs in 2018 and 2019, respectively, and incentivised companies to file for approval of these drugs. For example, the review time will be greatly reduced: three months for rare disease drugs and six months for other drugs.

Our analysis shows that the median approval time for the 16 such drugs approved in 2019 was 6.6 months. The shortest ones were Fingolimod hydrochloride and Edaravone, with three to four months from submission to approval.

A total of 74 drugs are included in the two lists mentioned above. By the end of 2019, 18 drugs had been approved, with the majority of the approvals (16 drugs) occurring in 2019 (Table 2).

Table 2. Drugs for Urgent Clinical Needs Approved in 2019
Source: Insight China Pharma Data

Drug Lag Remains

Figure 2 shows the approval of FDA-approved new products in China over the last five years. The US FDA approved a total of 219 new products between 2015 and 2019 and only 40 of them had been approved in China by the end of 2019 (Figure 2). While the review and approval of drugs in China has sped up notably since the regulatory reform in 2015, it is clear that reducing the long-standing drug lag will require more effort and will take a considerable time. With the new IND approval procedure in place, China will have more opportunities to participate in the global simultaneous development/application process, which will help expedite clinical development and regulatory review of innovative drugs in China.

Figure 2. Number of New Drug Approvals by US FDA and by the NMPA, 2015-2019
Source: Insight China Pharma Data

First Biosimilars Approval

In addition to innovative drug approvals, another highlight in 2019 was the first approval of biosimilars in China. On February 22, NMPA approved Rituximab Injection manufactured by a Chinese company, the first biosimilar approved in China since the release of the Technical Guidelines for Research, Development and Evaluation of Biosimilars in February 2015. In 2019, NMPA approved four biosimilars (Table 3).

Table 3. Approval of Biosimilars in 2019

Summary

NMPA approved a record-high 53 new drugs in 2019, with the highest (albeit small) number of innovative drugs ever developed by local companies. It is an indication of the growth of China’s drug innovation and development capacity and the positive outcomes of the regulatory reform.

On the other hand, there still is a considerable gap in the simultaneous global development and approval of innovative drugs in China. Further effort is needed to continue to enhance the regulatory system and to improve innovation capacity to fulfill the potential of innovation, drug development, and market access in China.

Author’s Note: All data were compiled from Insight China Pharma Data available on www.dxy.cn.

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