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In September 2022, the number of new drugs approved globally increased
significantly.
FDA approved 14 new drugs (NDA/BLA), including 5 newly approved new molecular entity drugs (NDA: Type 1 - New Molecular Entity) and 5 biological product drugs (BLA); EMA has authorized 5 new drugs to be marketed, including 4 new active substances (NAS); NMPA approved 2 innovative drugs for marketing, which are traditional Chinese medicines, which are Guangqian grass total flavonoid extract and capsules
of Renfu Pharmaceutical.
significantly.
In terms of medical devices, FDA has one product
that is on the market for the first time through the premarket approval (PMA) route.
In China, 9 Class III medical devices have entered the green channel for innovation approval, 2 innovative devices have been approved for marketing, and the approval of domestic medical devices is concentrated in vitro diagnostic reagents, with a total of 909, accounting for 32.
78%.
78%.
Global drug approvals
Global drug approvals(1) US FDA approval
(1) US FDA approval
Figure 1: Changes in the number of FDA drug approvals from January to September 2022 Source: US Food and Drug Administration
As shown in Figure 1, as of October 11, 2022, the FDA's official website disclosed that in September 2022, FDA completed a total of 80 initial approvals (excluding provisional approvals), of which 14 were approved by NDA/BLA (excluding provisional approvals), see Table 1
.
These include 5 newly approved new molecular entity drugs (NDA: Type 1 - New Molecular Entity) and 5 biologics drugs (BLA).
Boehringer Ingelheim's SPEVIGO is the world's first interleukin 36 receptor (IL-36R) monoclonal antibody approved by the FDA for generalized pustular psoriasis attacks in adults; SOTYKTU is a first-in-class oral selective allosteric tyrosine kinase 2 (TYK2) inhibitor, the only TYK2 inhibitor approved in the world, and the first innovative drug for the oral treatment of moderate to severe plaque psoriasis in the past 10 years; TERLIVAZ is the first drug in the United States to treat the rapid decline in kidney function in adults with hepatorenal syndrome and is a selective vasopressin analogue; PEDMARK (sodium thiosulfate injection) is the first FDA-approved treatment to reduce cisplatin-related ototoxicity in children with cancer, helping patients reduce the risk of hearing loss; RELYVRIO is the first treatment to significantly delay the progression of ALS disease and prolong survival in randomized, placebo-controlled clinical trials, and the third FDA-approved ALS treatment in 100 years; LYTGOBI is the third FGFR-targeted drug for cholangiocarcinoma approved in the United States, which has previously obtained FDA breakthrough therapy, orphan drug and priority review designation, and has been approved for marketing
through accelerated approval.
Table 1: List of NDA/BLA drugs approved by the FDA in September 2022
Source: U.
S.
Food and Drug Administration
(2) EU EMA approval
(2) EU EMA approval As of October 11, 2022, the number of recommended drugs and new active substances (NAS) listed from January to September 2022 is shown in Figure 2
.
In September 2022, the EMA did not recommend drugs for marketing
.
Figure 2: Changes in the number of drugs recommended for marketing by the EMA from January to September 2022 Source: Firestone Creation Industry Data Center
As of October 11, 2022, EMA authorized 5 new drugs to market in September, including 4 new active substances, as shown in Table 2
.
Lupkynis is a drug developed by Aurinia Pharma and licensed by Otsuka Pharmaceutical, and the first oral drug approved in the United States and the European Union for the treatment of lupus nephritis (LN), which can significantly improve renal response; Nulibry, the first and only drug in Europe to treat patients with molybdenum type A cofactor deficiency (MoCD), is a first-of-its-kind cPMP substrate replacement therapy approved by the FDA in 2021, and its marketing will bring treatment options to patients with the ultra-rare and progressive disease type A MoCD; Bristol-Myers Squibb's Opdualag, consisting of a novel LAG-3 blocking antibody relatlimab and a PD-1 inhibitor nivolumab (nivolumab), is the first regulatory-approved combination of LAG-3 blocking antibodies for the first-line treatment of melanoma; AstraZeneca's Tezspire is a first-in-class biologic that is suitable for a wide range of asthma patients with no phenotypic/biomarker restrictions
.
Table 2: List of drugs authorized by the EMA in September 2022
Source: Firestone Creation Industry Data Center
(3) NMPA ratification
(3) NMPA ratification As of October 11, 2022, the NMPA disclosed that a total of 52 domestic first-time registered drugs were approved in September 2022
.
After deduplication according to dosage form, a total of 37 drug varieties (different manufacturers produce the same drug according to the same variety).
This month, 2 product specifications (2 varieties) of Class 1 innovative drugs were approved, which are Chinese medicines
.
The status of Class 1 innovative drugs approved by the NMPA in September 2022 is shown in Table 3
.
Table 3: List of Class 1 innovative drugs approved by the NMPA
Source: State Drug Administration
Guangqian herb total flavonoids are innovative traditional Chinese medicine drugs independently developed by Renfu Pharmaceutical, and are the third Class 1 innovative drugs
approved by the company.
Compared with the surgical lithotripsy method used in clinical practice, the total flavonoids of Guangqiancao can reduce the damage to the body, and the launch of this drug will provide a new treatment option
for patients with diaphragm and heat syndrome in traditional Chinese medicine for ureteral stones.
(4) Consistency evaluation of generic drugs
(4) Consistency evaluation of generic drugs As of October 11, 2022, the official website of CDE disclosed that CDE has undertaken a total of 4,241 acceptance numbers for drug consistency evaluation, and a total of 69 new acceptance numbers
have been added in September 2022.
As of October 11, 2022, a total of 4,776 products of specifications have passed the consistency evaluation (including deemed to have passed the 2010 specifications), and a total of 77 specifications of drugs have passed the consistency evaluation (including deemed to have passed 5 specifications) this month, and a total of 53 drug varieties
have been deduplicated according to dosage form.
At present, a total of 1732 specifications (263 varieties) of injections have passed the consistency evaluation variety, and a total of 38 specifications (22 varieties) of injections
have been evaluated this month.
The number of conformity evaluations passed from January to September 2022 is shown in Figure 3
.
Figure 3: Changes in the number of approvals for consistency evaluation of generic drugs from January to September 2022 Source: State Medical Products Administration
Global medical device approvals
Global medical device approvals(<>) US FDA approval
(<>) US FDA approval As of October 11, 2022, the FDA approved a total of 284 510(k) pathway products in September, including 23 Class I devices, 252 Class II devices, and 9 unclassified
devices.
By classifying the devices notified before the 510(k) market use according to U.
S.
medical professional use, it was found that the most approved types of products in September were general and orthopedic instruments, orthopedic devices, radiology devices, general hospital and personal use devices, and dental instruments, as shown in Figure 4
.
Figure 4: Distribution of product types approved for marketing through FDA 510(k) in September 2022 Source: U.
S.
Food and Drug Administration
In September 2022, there was one product
that was first launched through the Premarket Approval (PMA) route.
Table 4: Devices first approved by the PMA in September 2022
Source: U.
S.
Food and Drug Administration
(2) Domestic approvals
(2) Domestic approvals As of October 11, 2022, the State Administration announced that 9 Class III medical devices entered the green channel for innovation approval in September 2022, as shown in Table 5
.
Table 5: Three types of innovative devices that entered the green channel in September 2022
Source: National Medical Device Evaluation Center
As of October 11, 2022, the State Administration announced in September 2022 that two Class III innovative devices have been approved for marketing, as shown in Table 6
.
Table 6: Three types of innovative devices approved for marketing in September 2022
Source: National Medical Device Evaluation Center
As of October 11, 2022, in September 2022, the State Administration approved a total of 187 Class III medical device products for the first registration, of which 162 were made in China and 25 were
imported.
In September, provincial drug regulatory authorities approved a total of 960 domestic Class II medical device registrations and 1,496 Class I medical devices for filing
.
Statistics show that in vitro diagnostic reagents have the largest number, with a total of 909 items, accounting for 32.
78%, basically all domestic, with 886 items
.
In addition to in vitro diagnostic reagents, the top three approved registration categories are infusion, nursing and protective equipment, clinical laboratory equipment and dental equipment
.
Table 7: Distribution of the number of approved registration categories for domestic and imported medical devices in September 2022
Source: National Medical Device Evaluation Center
In terms of geographical distribution, in September 2022, the largest number of approvals for domestic Class II and III registered products were Guangdong Province (250 cases), Hunan Province (192 cases), and Jiangsu Province (168 cases), as shown in Figure 5
.
Figure 5: Regional distribution of domestic approved devices Source: Firestone Creation Industry Data Center
