YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 154 drug applications between 19 May 2022 and 25 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 24, covering 18 drug names.
2022/05/19 – 2022/05/25
- New acceptances this week
- 154
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- Accepted this week, now under review
- 0
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
154filings, 24 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 69 |
| New drug | 33 |
| Generic | 24 |
| Import | 15 |
| Import re-registration | 9 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 118 |
| Therapeutic biologic | 21 |
| TCM | 12 |
| Biologic | 3 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
18 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Piperacillin Sodium for Injection | 5 | 2 | 16 |
| 2 | Budesonide Nasal Spray | 2 | 1 | 3 |
| 3 | Mirabegron Extended-release Tablets | 2 | 1 | 1 |
| 4 | Candesartan Cilexetil Tablets | 1 | 1 | 0 |
| 5 | Levetiracetam Oral Solution | 1 | 1 | 3 |
| 6 | Saxagliptin and Metformin Hydrochloride Sustained-release Tablets | 1 | 1 | 2 |
| 7 | Saxagliptin and Metformin Hydrochloride Sustained-release Tablets | 1 | 1 | 2 |
| 8 | Lopinavir and Ritonavir Tablets | 1 | 1 | 0 |
| 9 | Phentolamine Mesilate Injection | 1 | 1 | 3 |
| 10 | Urapidil Hydrochloride Injection | 1 | 1 | 6 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
87 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bo Zhou Ya Ying Pharmaceuticals Technology Co., Ltd. romanized | 6 | 6 | 0 |
| 2 | Qilu Pharmaceutical Co., Ltd. | 6 | 3 | 0 |
| 3 | ASPEN PHARMA TRADING LIMITED | 5 | 1 | 0 |
| 4 | Jilin Sheng Dou Bang Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 5 | Ren He Yi Kang Group Co., Ltd. romanized | 4 | 3 | 1 |
| 6 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Santen Pharmaceutical Co. Ltd. | 4 | 1 | 0 |
| 8 | Karuna Therapeutics Inc. | 3 | 1 | 0 |
| 9 | Kyowa Kirin Co. Ltd. | 3 | 1 | 0 |
| 10 | Merck Serono S.p.A | 3 | 1 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
54 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/05/25Import · Class 3.1 | Netakimab注射液 · No verified English nameJXSL2200061 | Joint Stock Company “BIOCAD”,(JSC “BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd. |
| 2022/05/25Import · Class 1 | SQZ-AAC-HPV · No verified English nameJXSL2200060 | SQZ Biotechnologies Company; ICON Clinical Research (Beijing No.2) Co. Ltd. |
| 2022/05/25Import · Class 1 | ALXN2050片 · No verified English nameJXHL2200120 | Alexion Pharmaceuticals Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2022/05/25Generic · Class 3 | 维氟醌乳膏 · No verified English nameCYHS2200748 | Zhejiang Fu Nuo Pharmaceuticals Co., Ltd. romanized |
| 2022/05/25New drug · Class 2.2 | 注射用右兰索拉唑 · No verified English nameCXHS2200027 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized |
| 2022/05/25New drug · Class 2.2 | 盐酸美金刚颗粒 · No verified English nameCXHL2200330 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2022/05/25New drug · Class 2.2 | 盐酸美金刚颗粒 · No verified English nameCXHL2200329 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2022/05/25New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2200326 | Qilu Pharmaceutical Co., Ltd. |
| 2022/05/25New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2200325 | Qilu Pharmaceutical Co., Ltd. |
| 2022/05/25New drug · Class 1 | BB102片 · No verified English nameCXHL2200324 | Beijing Bo Hui Bio Technology Co., Ltd. romanized |
| 2022/05/25New drug · Class 1 | BB102片 · No verified English nameCXHL2200323 | Beijing Bo Hui Bio Technology Co., Ltd. romanized |
| 2022/05/25New drug · Class 1 | 注射用MT1011 · No verified English nameCXHL2200322 | Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized |
| 2022/05/24Import · Class 1 | AZD7789 · No verified English nameJXSL2200059 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/05/24Import · Class 1 | Relatlimab注射液 · No verified English nameJXSL2200058 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2022/05/24Import · Class 1 | CAN1012注射液 · No verified English nameJXHL2200119 | CanWell Pharma Inc. |
| 2022/05/24Import · Class 2.4 | Rimegepant口崩片 · No verified English nameJXHL2200115 | Biohaven Pharmaceutical Ireland Designated Activity Company; BioShin (Shanghai) Co. Ltd. |
| 2022/05/24Import · Class 2.4 | Rimegepant口崩片 · No verified English nameJXHL2200114 | Biohaven Pharmaceutical Ireland Designated Activity Company; BioShin (Shanghai) Co. Ltd. |
| 2022/05/24Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2200757 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2022/05/24Generic · Class 3 | Piperacillin Sodium for InjectionCYHS2200756 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2022/05/24Generic · Class 3 | Piperacillin Sodium for InjectionCYHS2200755 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2022/05/24Generic · Class 3 | Piperacillin Sodium for InjectionCYHS2200754 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2022/05/24Generic · Class 3 | Piperacillin Sodium for InjectionCYHS2200750 | Nanjing Feng Kai Si Drug Research and Development Co., Ltd. romanized; Jiangsu Hai Hong Pharmaceutical Co., Ltd. romanized |
| 2022/05/24Generic · Class 3 | Piperacillin Sodium for InjectionCYHS2200749 | Nanjing Feng Kai Si Drug Research and Development Co., Ltd. romanized; Jiangsu Hai Hong Pharmaceutical Co., Ltd. romanized |
| 2022/05/24Generic · Class 3 | Magnesium Sulfate InjectionCYHS2200746 | Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized |
| 2022/05/24Generic · Class 3 | 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2200744 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2022/05/24Generic · Class 3 | Memantine Hydrochloride Oral SolutionCYHS2200742 | Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2022/05/24New drug · Class 1.1 | 柴芩通淋片 · No verified English nameCXZL2200024 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2022/05/24New drug · Class 1 | Domvanalimab注射液 · No verified English nameCXSL2200221 | Shanghai Bai Li Jia Sheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/05/24New drug · Class 3.3 | CMAB015注射液 · No verified English nameCXSL2200220 | Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized |
| 2022/05/24New drug · Class 1 | MG-ZG122人源化单抗注射液 · No verified English nameCXSL2200219 | Shanghai Mai Ji Bio Technology Co., Ltd. romanized |
24 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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