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Annual Report: 2022 Global Drug and Device Approval Report

 Last Update: 2023-02-02
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preface

In 2022, the number of new drugs approved worldwide was relatively stable, with the FDA completing a total of 802 first drug approvals (excluding provisional approvals), of which 121 new drugs (NDA/BLA) were approved, including 23 newly approved new molecular solid drugs (NDA:Type).
1 - New Molecular Entity), 25 biologics drugs (BLAs).

EMA authorized a total of 96 drugs to market, including 47 new active substance drugs
.

In 2022, the number of new drugs approved worldwide will be relatively stable.

With the real-time adjustment of the new crown epidemic prevention and control measures and the excellent performance of approved innovative drugs in 2021, the number of domestic innovative drugs approved in 2022 has fallen
off a cliff.
The NMPA approved 22 varieties of innovative drugs for marketing (excluding 4 varieties specially approved for the prevention/treatment of the new crown), including 6 traditional Chinese medicines, 10 chemical drugs and 6 biological products
.
In 2022, the NMPA approved the listing of Lingguishu Gan Granules, the first traditional Chinese medicine compound preparation (i.
e.
a new drug of Class 3.
1 in traditional Chinese medicine) managed according to the catalogue of ancient classical formulas, which is a vivid practice
to promote the transformation of new drugs in the direction of ancient classic names.
The consistency evaluation of generic drugs continued to be carried out steadily, with 1,528 product specifications evaluated in 2022, of which injections accounted for about 51%.

For medical devices in 2022, FDA had 22 products
that were first marketed through the premarket approval (PMA) route.
In China, 67 Class III medical devices have entered the green channel of innovation approval, 54 innovative devices have been approved for marketing, and the approval of domestic medical devices is concentrated in vitro diagnostic reagents, with a total of 12,628 items, accounting for 29.
14%.

For medical devices in 2022, FDA had 22 products
that were first marketed through the premarket approval (PMA) route.

01 Global drug approvals

(1) FDA approval

Figure 1 Changes in the number of FDA drug approvals from 2013 to 2022 Source: US Food and Drug Administration

As shown in Figure 1, as disclosed on the FDA's official website on January 5, 2023, the FDA has completed a total of 802 first drug approvals (excluding provisional approvals) in 2022, of which 121 NDA/BLA approvals (excluding provisional approvals).

These include 23 newly approved new molecular solid drugs (NDA:Type 1 - New Molecular Entity), see Table 1, 25 Biologics Drugs (BLAs).

Table 1 FDA approves new molecular entity drugs in 2022

Source: U.
S.
Food and Drug Administration

(2) EU EMA approval

As disclosed on the EMA official website on January 5, 2023, the number of recommended drugs and recommended new active substances (NAS) for marketing from 2013 to 2022 is shown in Figure 2
.

Figure 2 Changes in the number of drugs recommended for marketing by EMA from 2013 to 2022 Source: Firestone Creation Industry Data Center

As of January 5, 2023, EMA has authorized a total of 96 drugs to market in 2022, of which 47 new active substance drugs have been authorized, including 6 first-in-class drugs
.
Among the R&D companies, AstraZeneca AB and Novartis have the most authorized drugs, each with 4 drugs, Bristol-Myers Squibb and Eli Lilly, Genzyme, Pfizer, and Roche each have 2 drugs on the market, ranking in the second echelon
.
Details are shown in Table 2
.

Table 2 List of new active substance drugs authorized by EMA in 2022

Source: Firestone Creation Industry Data Center

(3) NMPA approval

As of January 5, 2023, the NMPA disclosed that a total of 1,001 domestically
registered drugs were approved for the first time in 2022.
After deduplication according to dosage form, a total of 428 drug varieties (different manufacturers produce the same drug according to the same variety), a total of 30 specifications (22 varieties) and Class 1 innovative drugs were approved for marketing, including 16 specifications (10 varieties) of chemical drugs, 8 specifications (6 varieties) of biological products and 6 specifications (6 varieties) of traditional Chinese medicines
.
According to product regulations, the approval of innovative drugs decreased by 43.
14%
compared with 2021.
The status of Class 1 innovative drugs approved by NMPA in 2022 is shown in Table 3
.

In 2022, 21 innovative drugs will be listed on the market, of which Bayer and Wuhan Optics Valley Renfu Company will be the most approved, both of which have been approved for 2 varieties of innovative drugs
。 Bayer's velicigat tablets, which were approved by priority review and marketing in May 2022, are guanylate cyclase (sGC) agonists jointly developed by Bayer and Merck, which were approved by the FDA on January 20, 2021, and are the world's first innovative drug (first-in-class), which has also been approved for marketing in China after more than a year, and its listing provides a new treatment option for adult patients with symptomatic chronic heart failure; In June, Bayer launched another drug for the treatment of chronic kidney disease associated with type 2 diabetes: fenelidone, a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, which has been marketed
in many countries and regions, including the United States and Europe, before the NMPA was approved.

Wuhan Optics Valley Renfu Company (Renfu Pharmaceutical) was also approved to market two varieties of innovative traditional Chinese medicine drugs in 2022, namely Guangqian Grass Total Flavonoid Extract and Guangqian Grass Total Flavonoid Capsules, compared with the surgical lithotripsy method currently used in clinical practice, Guangqian Grass Total Flavonoids can reduce the damage
to the body.
Guangqian Grass Total Flavonoid Capsule is the world's first new Chinese medicine drug for the prevention and treatment of urinary stones, and it is also the third Class 1 innovative drug
approved by Renfu Pharmaceutical after the Class 1 chemical drugs remazolam besylate and fopropofol disodium disodium

In 2022, the NMPA approved the marketing of a total of 6 varieties of innovative traditional Chinese medicine drugs, in addition to the above 2 varieties of Renfu Pharmaceutical, namely Icariin and Icariin Softgels approved in January, Anbang Pharmaceutical's Qi Jiao Meadian Granules, and Huachun Bio Ginseng Kidney Supplement Capsules
approved in December 。 In addition to these Class 1 innovative drugs, the NMPA also announced on December 28, 2022 to approve the listing of Lingguishu Gan Granules, the first traditional Chinese medicine compound preparation (i.
e.
Class 3.
1 new drugs of Chinese medicine) managed according to the Catalogue of Ancient Classic Formulas, which is derived from Han Zhang Zhongjing's "Essentials of Jin Kuang" and has been listed in the Catalogue of Ancient Classic Formulas (First Batch), and the marketing authorization holder is Jiangsu Kangyuan Pharmaceutical
.
In recent years, the State Food and Drug Administration has actively implemented the relevant provisions and spirit of the Law of the People's Republic of China on Traditional Chinese Medicine and other documents, and actively cooperated with the State Administration of Traditional Chinese Medicine in issuing the catalogue of ancient classic recipes and their key information research opinions
.
At the same time, the State Food and Drug Administration formulated and issued the Administrative Provisions on the Simplified Registration and Approval of Ancient Classic Prescription Chinese Medicine Compound Preparations, and implemented various measures to promote the research and development of
ancient classic Chinese medicine compound preparations.
The listing of Linggui Shugan granules is a vivid practice
to deeply explore the essence of the treasure house of traditional Chinese medicine and promote the transformation of new drugs in ancient classics.

Among the Class 1 innovative drugs approved for marketing in 2022, 5 varieties belong to the world's first innovative drugs (first-in-class), in addition to the above-mentioned Bayer Vericiguan tablets, Cannoki Pharmaceutical's icariin softgels, Renfu Pharmaceutical's Guangqian Grass total flavonoid capsules, as well as Akeso bio cardunilimab injection and Hua Medicine Docagliatin tablets
。 Akeso's self-developed cardonilimab injection is the world's first CRLA4/PD-1 dual antibody for the treatment of recurrent or metastatic cervical cancer, filling the market gap in the research and development of domestic bispecific antibody drugs, and Akeso's other PD-1/VEGF bispecific antibody evocimab was recently licensed to Summit in the United States, Canada, Europe and Japan Therapeutics, which will pay a $500 million down payment and up to $5 billion in total transaction value, will become the second largest overseas licensing deal (License) for domestic new drugs in 2022 out）； The dogliatin tablets developed by Hua Medicine is the world's first approved glucokinase activator drug, the first original innovative drug with a new mechanism in the field of diabetes in the past decade, and the world's first innovative drug
for type 2 diabetes launched in China.

Table 3 List of Class 1 innovative drugs approved by NMPA in 2022

Source: State Drug Administration

In terms of geographical distribution, the largest number of approved innovative drug companies in 2022 are Shanghai (4 enterprises, holding 4 varieties of drugs), Shandong Province (3 enterprises, holding 3 varieties of drugs), and Beijing/Jiangsu Province (2 enterprises, holding 2 varieties of drugs), see Figure 3
.

Figure 3 Regional distribution of approved innovative drugs in 2022 Source: NMPA

As of January 5, 2023, with the adjustment of epidemic prevention and control policies, in order to prevent/treat COVID-19 new coronavirus, the NMPA conducted emergency review and approval in 2022 in accordance with the special approval procedure for drugs, and conditionally approved the marketing of vaccines/drugs of 5 product specifications (4 varieties), see Table 4; At the same time, on December 30, the NMPA approved the listing of 12 symptomatic treatment drugs for new coronavirus infection, including ibuprofen suspension
, through the rapid review channel.

Table 4 List of drugs specially approved by NMPA in 2022

Source: State Drug Administration

(4) Evaluation of the consistency of generic drugs

(<>) Evaluation of the consistency of generic drugs

As of January 5, 2023, CDE's official website disclosed that CDE has undertaken a total of 4,426 acceptance numbers for drug consistency evaluation, and a total of 835 new acceptance numbers
will be added in 2022.
As of January 5, 2023, a total of 5,110 listed drugs have passed the consistency evaluation (including 2,199 specifications deemed to have passed), and a total of 1,528 drugs with specifications in 2022 have passed the consistency evaluation (including 703 specifications deemed to have passed the specifications), and a total of 492 drug varieties
have been deduplicated according to dosage forms.

At present, a total of 1901 specifications (273 varieties) of injectables have passed the consistency evaluation varieties, and a total of 777 specifications (196 varieties) of injectables
have been evaluated in 2022.
The number of consensus evaluations passed from 2018 to 2022 is shown in Figure 4
.

Figure 4 Changes in the number of approvals for consistency evaluation of generic drugs from 2018 to 2022 Source: NMPA

02 Global medical device approval

(<>) FDA approval

As of January 5, 2023, FDA approved a total of 3,229 products in the 510(k) pathway in 2022, including 262 Class I devices, 2,895 Class II devices, and 72 unclassified
.
A total of 22 IPOs were made through pre-market approval (PMA) in 2022
.

By classifying the 510(k) premarket notification devices according to the US medical specialty use, it was found that the most approved types of products in 2022 were general and plastic surgical instruments, orthopedic instruments, radiology instruments, general hospital and personal use devices, and cardiovascular devices, as shown in Figure 5
.

Figure 5 Distribution of product types approved for marketing through FDA 510(k) in 2022 Source: U.
S.
Food and Drug Administration

Table 5 Devices first approved by PMA in 2022

Source: U.
S.
Food and Drug Administration

(2) Domestic approvals

As of January 5, 2023, the State Administration announced that 67 Class III medical devices have entered the green channel for innovation approval in 2022, as shown in Table 6
.

Table 6 Three types of innovative devices that will enter the green channel in 2022

Source: National Medical Device Evaluation Center

As of January 5, 2023, the State Administration announced that 54 Class III innovative devices had been approved for marketing in 2022, as shown in Table 7
.

Table 7 Three types of innovative devices approved for marketing in 2022

Source: National Medical Device Evaluation Center

As of January 5, 2023, in 2022, the State Administration approved the first registration of 2,172 Class III medical device products, of which 1,818 were made in China and 354 were imported
.
In 2022, provincial drug regulatory authorities approved a total of 13,063 domestic Class II medical device registrations and 27,117 Class I medical devices for recordation
.

Statistics show that the number of in vitro diagnostic reagents is the largest, with a total of 12628, accounting for 29.
14%, basically all domestic, 12415 items
.
In addition to in vitro diagnostic reagents, the top three approved registration categories are infusion, nursing and protective devices, clinical testing devices and stomatological devices
.

Table 8 Distribution of the number of approved registration categories of domestically produced and imported medical devices in 2022

Source: National Medical Device Evaluation Center

In terms of geographical distribution, the three regions with the largest number of approvals for domestic Class II and III registered products in 2022 were Guangdong Province (2,290), Hunan Province (2,277), and Jiangsu Province (2,187), as shown in Figure 6
.

Figure 6 Regional distribution of domestically produced approved devices Source: Firestone Creation Industry Data Center

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