According to the latest statistics of Yaozhi Data, in May 2021, CDE has undertaken a total of 820 new drug registration applications (except for re-examination, the same below), including 614 chemical drugs, 75 traditional Chinese medicines, and 131 biological products. ; Figure 1 shows the acceptance status of various drug registration applications from January to May 2021.
Figure 1 CDE drug acceptance status from January to May 2021
Data source: Yaozhi data, Yaozhi consultation and collation
Let's look at the detailed analysis of the registration acceptance and review of chemical drugs, traditional Chinese medicines, and biological products.
一. Review of chemical drugs
In May, CDE undertook a total of 614 new chemical drug registration applications with acceptance numbers. The main types of applications were supplementary applications, the number was the same as last month, with 329 acceptance numbers, followed by imitation applications with 107 acceptance numbers. Among them, the number of new drug applications has decreased, with a total of 77 acceptance numbers; the acceptance status of each application type of CDE chemical drugs from January to May 2021 is shown in Figure 2.
Figure 2 The acceptance status of various application types of CDE chemical drugs from January to May 2021
Data source: Yaozhi data, Yaozhi consultation and collation
1. Status of domestic application for category 1 chemical drugs
In May, CDE accepted a total of 59 domestically produced Class 1 new drugs (according to the acceptance number), of which 56 were IND applications and 3 were NDA applications, involving 31 companies in 33 varieties; the following table shows the newly contracted Class 1 in May New domestic drugs.
Table 1 New domestic new drugs of category 1 of chemical drugs contracted in May 2021
Note: The queuing number ends on June 3, 2021.
Data source: Yaozhi data, Yaozhi consultation and collation
2. Application status of category 1 imported drugs
In May, a total of 29 imported chemical drugs category 1 acceptance numbers were accepted, all of which were IND applications, involving 13 companies in 13 varieties; the following table shows the category 1 imported new drugs newly undertaken in May.
Table 2 New imported chemical drugs of category 1 under the contract in May 2021
Note: The queuing number ends on June 3, 2021
Data source: Yaozhi data, Yaozhi consultation and collation
SPH5030 tablets
SPH5030 is a category 1 innovative drug independently developed by Shanghai Pharmaceuticals and has complete intellectual property rights. The project was initiated in July 2019, and the preclinical research was completed in December 2020. The total investment in research and development costs is about RMB 25,009,400; SPH5030 is a new type of drug. Small molecule inhibitors are intended to be used in the treatment of advanced solid tumors; currently, drugs similar to those of the SPH5030 project have been marketed globally.
HSK21542 injection
HSK21542 injection is a brand-new Class 1 innovative drug with independent intellectual property rights. It is intended to be used for the treatment of acute and chronic pain, pruritus and other indications. The indication for "acute and chronic pain" was approved to enter the clinic in December 2019, and the phase III clinical trial protocol was approved by the CDE in March 2021; the indication for "pruritus" was approved to enter the clinic in May 2020, this time The accepted indication is "hepatic pruritus". HSK21542 injection was launched in Australia from October 2019 to October 2020 in Phase I clinical trials; January 2020 to September 2020 in China launched Phase I clinical trials; from June 2020 to February 2021 in China China has launched a phase II clinical trial for postoperative pain relief after abdominal laparoscopic surgery, and is currently undergoing phase III clinical trials for this indication; in addition, HSK21542 is currently undergoing phase II clinical trials in hemodialysis subjects test.
SPH3127 tablets
SPH3127 was jointly developed by Shanghai Pharmaceuticals and Japan's Tanabe Mitsubishi Pharmaceutical Co., Ltd., and the two parties jointly own the intellectual property rights of a Class 1 innovative drug. The project was initiated in May 2019, and the preclinical study will be completed in October 2020. At present, the hypertension indication is undergoing phase III clinical trials in China, and the mild to moderate ulcerative colitis indication is undergoing phase II clinical trials in the United States. This drug application intends to carry out clinical trials with chronic kidney disease as the indication; currently there is no drug with the same target and the same indication on the market in the world.
ASC40 tablets
The application for the clinical trial application of ASC40 combined with bevacizumab for the treatment of patients with recurrent glioblastoma (rGBM) has been accepted; the ASC40 combined with bevacizumab treatment completed in the United States (foreign code name TVB-2640) The phase II clinical trial of patients with high-grade astrocytoma recurrence for the first time, that is, patients with recurrent glioblastoma, achieved positive results (clinical trial registration number: NCT03032484), and the phase II clinical trial data showed that ASC40 plus bevacizumab The overall response rate (ORR) is 65%, including 20% complete response (CR) and 45% partial response (PR); the 6-month progression-free survival (PFS6) observed with ASC40 combined with bevacizumab ) Was 47%. Compared with the historical data of bevacizumab monotherapy (BELOB16%), the 6-month progression-free survival (PFS6) was statistically significantly improved (P = 0.01).
BGB-15025 capsules
BGB-15025 capsule is BeiGene's first-in-class HPK1 inhibitor, which belongs to a class 1 innovative drug. The clinical application indication is the treatment of solid tumors.
GFH925 tablets
GFH925 tablet is a class 1 innovative drug applied by Jinfang Pharmaceutical for clinical trials. Its target of action is KRAS G12C. It is intended to be developed for the treatment of solid tumors such as NSCLC. At present, no targeted drug has been approved for marketing at home and abroad, but many drugs are in clinical trials, including Amgen’s sotorasib (AMG 510), Mirati Therapeutics and Novartis’s Adagrasib (MRTX849), and Eli Lilly. LY3537982, ARS-3248 from Araxes (a subsidiary of Wellspring), BPI-421286 from Betta Pharmaceuticals, etc.; among them, Amgen’s sotorasib (AMG 510) has made the fastest progress and has been in the United States and Europe in December last year. Submitted for marketing application, the indication is that it has previously received at least one systemic therapy, and the FDA-approved detection method confirms the presence of KRAS G12C mutation, locally advanced or metastatic NSCLC, which has also been granted priority review by the FDA in the United States.
HSK16149 capsules
HSK16149 capsules are independently developed by Sichuan Haisco Pharmaceutical Co., Ltd. and have the exclusive license to implement the HSK16149 patent in China. They are currently intended to be used for the treatment of diabetic peripheral neuralgia and post-herpetic neuralgia. . The variety received clinical approval for the indications of "diabetic peripheral neuralgia and post-herpetic neuralgia" in October 2019, and the indication accepted this time is "auxiliary analgesia".
Limpris tablets
Linpris tablets are a class 1 innovative drug independently developed by Shanghai Yingli Pharmaceutical Co., Ltd., which is intended to be used for the treatment of relapsed/refractory follicular lymphoma. In China, there is no marketed drug with the same target, but two drugs have obtained the priority review qualification of CDE, namely Copanlisib and Duensibu.
Compound ACC007 Tablets
Compound ACC007 is a non-nucleoside reverse transcriptase inhibitor with a brand-new structure. It is the company's first class 1 new anti-AIDS drug and has been included in the national 13th Five-Year "Major new drug creation" major science and technology project. The Phase III clinical trial has been completed, with good results and reaching the main clinical endpoint indicators.
2. Review of Traditional Chinese Medicines
In May, the CDE undertook a total of 75 acceptance numbers for new Chinese medicine registration applications, including 3 new medicines and 72 supplementary applications. The acceptance status of each application type of CDE Chinese medicine from January to May 2021 is shown in Figure 3.
Figure 3 The acceptance status of CDE Chinese medicine application types from January to May 2021
Data source: Yaozhi data, Yaozhi consultation and collation
In May, a total of 3 TCM Class 1 Innovative Drug Acceptance Numbers were accepted, all of which were IND applications. The following table shows the newly contracted TCM Class 1 Innovative Drugs in May.
Table 3 New Class 1 Innovative Medicines of Traditional Chinese Medicines Undertaken in May 2021
Note: The queuing number ends on June 1, 2021
Data source: Yaozhi data, Yaozhi consultation and collation
3. Review of biological products
In May, CDE undertook a total of 131 new application acceptance numbers for biological product registration, 53 new drugs, 56 supplementary applications, 18 imports, and 4 re-registrations; details of the acceptance status of each application type of CDE biological products from January to May in 2021 See Figure 4.
Figure 4 The acceptance status of various application types for CDE biological products from January to May 2021
Data source: Yaozhi data, Yaozhi consultation and collation
In May, 37 category 1 therapeutic biological product acceptance numbers were accepted, all of which are clinical trial applications, and have now entered the corresponding sequence for review; the following table shows the new category 1 innovative drugs for biological products under May.
Table 4 New Class 1 New Drugs for Therapeutic Biological Products Undertaken in May 2021
Note: The queuing number ends on June 3, 2021.
Data source: Yaozhi data, Yaozhi consultation and collation
4. Evaluation of the declared varieties according to consistency
In May, 74 acceptance numbers and 114 deemed acceptance numbers were added for declarations made in accordance with the consistency evaluation requirements. (The space limit only displays the consistency information. Please pay attention to the drug intelligence enterprise version drug registration and acceptance database for deemed and specific information); see Figure 5 for the number of consistency evaluation acceptances from January to May 2021; Table 5 is newly added in May Consistency evaluation acceptance number information.
Figure 5 Number of acceptances for consistency evaluation from January to May 2021
Data source: Yaozhi data, Yaozhi consultation and collation
Table 5 Newly-added acceptance data for consistency evaluation in May 2021
Data source: Yaozhi drug registration and acceptance database, Yaozhi consultation and collation
