YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 507 drug applications between 6 May 2023 and 12 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 68 drug names.
2023/05/06 – 2023/05/12
- New acceptances this week
- 507
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- Accepted this week, now under review
- 2
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
507filings, 93 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 273 |
| Generic | 93 |
| New drug | 87 |
| Import | 31 |
| Import re-registration | 12 |
| Unspecified | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 335 |
| TCM | 110 |
| Therapeutic biologic | 61 |
| Prophylactic biologic | 1 |
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
68 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 硝普钠氯化钠注射液 · No verified English name | 4 | 1 | 3 |
| 2 | Dasatinib Tablets | 4 | 1 | 4 |
| 3 | Levofloxacin Eye Drops | 3 | 3 | 16 |
| 4 | 吸入用七氟烷 · No verified English name | 3 | 1 | 0 |
| 5 | Arginine and Ibuprofen Granules | 3 | 1 | 11 |
| 6 | Famotidine Injection | 2 | 2 | 8 |
| 7 | Minoxidil Liniment | 2 | 2 | 52 |
| 8 | Crisaborole Ointment | 2 | 1 | 26 |
| 9 | Carbazochrome Sodium Sulfonate Injection | 2 | 1 | 1 |
| 10 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
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
234 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | An Yang Guang Sheng Heng Pharmaceutical Co., Ltd. romanized | 62 | 50 | 0 |
| 2 | Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized | 28 | 23 | 0 |
| 3 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 15 | 14 | 0 |
| 4 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized | 12 | 1 | 0 |
| 5 | Novo Nordisk A/S | 8 | 2 | 0 |
| 6 | Bard Pharmaceuticals Limited | 7 | 3 | 0 |
| 7 | Qilu Pharmaceutical (Hainan) Co., Ltd | 6 | 2 | 4 |
| 8 | AbbVie Limited | 6 | 1 | 0 |
| 9 | Eli Lilly and Company | 6 | 1 | 0 |
| 10 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 5 | 5 | 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
145 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/12Import · Class 3.1 | Nirsevimab注射液 · No verified English nameJXSS2300038 | AstraZeneca AB; Patheon Manufacturing Services LLC; Name not romanized |
| 2023/05/12Import · Class 3.1 | Nirsevimab注射液 · No verified English nameJXSS2300037 | AstraZeneca AB; Patheon Manufacturing Services LLC; Name not romanized |
| 2023/05/12Import · Class 2.2 | Anifrolumab注射液 · No verified English nameJXSL2300092 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2023/05/12Generic · Class 3 | Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2301300 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2023/05/12Generic · Class 3 | Formoterol Fumarate Inhalation SolutionCYHS2301297 | Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2023/05/12Generic · Class 3 | 硝普钠氯化钠注射液 · No verified English nameCYHS2301295 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized |
| 2023/05/12Generic · Class 3 | 硝普钠氯化钠注射液 · No verified English nameCYHS2301294 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized |
| 2023/05/12Generic · Class 3 | 硝普钠氯化钠注射液 · No verified English nameCYHS2301293 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized |
| 2023/05/12Generic · Class 3 | 硝普钠氯化钠注射液 · No verified English nameCYHS2301292 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized |
| 2023/05/12New drug · Class 3.3 | SAL023注射液 · No verified English nameCXSL2300332 | Xin Li Tai (Chengdu) Bio Technology Co., Ltd. romanized; Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2023/05/12New drug · Class 1 | 注射用QLS31905 · No verified English nameCXSL2300331 | Qilu Pharmaceutical Co., Ltd. |
| 2023/05/12New drug · Class 1 | 镥[177Lu]JH020002注射液 · No verified English nameCXHL2300514 | Jing He Biopharmaceuticals Technology (Nanjing) Co., Ltd. romanized; Jing He Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/05/12New drug · Class 1 | KH607片 · No verified English nameCXHL2300513 | Chengdu Kang Hong Pharma Group Co., Ltd. romanized |
| 2023/05/12New drug · Class 1 | KH607片 · No verified English nameCXHL2300512 | Chengdu Kang Hong Pharma Group Co., Ltd. romanized |
| 2023/05/12New drug · Class 1 | KH607片 · No verified English nameCXHL2300511 | Chengdu Kang Hong Pharma Group Co., Ltd. romanized |
| 2023/05/12New drug · Class 2.3 | 海博麦布阿托伐他汀钙片 · No verified English nameCXHL2300510 | Han Hui Pharmaceutical Co., Ltd. romanized |
| 2023/05/12New drug · Class 2.3 | 海博麦布阿托伐他汀钙片 · No verified English nameCXHL2300509 | Han Hui Pharmaceutical Co., Ltd. romanized |
| 2023/05/11Import · Class 1 | EYP-1901玻璃体内植入剂 · No verified English nameJXHL2300114 | EyePoint Pharmaceuticals Inc.; Betta Pharmaceuticals Co. Ltd. |
| 2023/05/11Import · Class 1 | EYP-1901玻璃体内植入剂 · No verified English nameJXHL2300113 | EyePoint Pharmaceuticals Inc.; Betta Pharmaceuticals Co. Ltd. |
| 2023/05/11Import · Class 1 | BRII-835 (VIR-2218) 注射液 · No verified English nameJXHL2300112 | Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited |
| 2023/05/11Generic · Class 3 | Famotidine InjectionCYHS2301278 | Shaanxi Li Cai Pharma Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2023/05/11Generic · Class 3 | Famotidine InjectionCYHS2301277 | Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized |
| 2023/05/11Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2301276 | Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/05/11Generic · Class 3 | 阿瑞匹坦注射液 · No verified English nameCYHS2301274 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/05/11Generic · Class 3 | Peramivir InjectionCYHS2301271 | Hubei Min Kang Pharma Group Co., Ltd. romanized; Hubei Mei Lin Pharma Co., Ltd. romanized |
| 2023/05/11New drug · Class 1 | 注射用A166 · No verified English nameCXSS2300034 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2023/05/11New drug · Class 1 | FL115注射液 · No verified English nameCXSL2300329 | Suzhou Fu Rong Bio Technology Co., Ltd. romanized |
| 2023/05/11New drug · Class 1 | ReT01 ACT 注射液 · No verified English nameCXSL2300328 | Beijing An Wei Sen Biopharmaceuticals Co., Ltd. romanized |
| 2023/05/11New drug · Class 1 | ISM8207胶囊 · No verified English nameCXHL2300508 | Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized |
| 2023/05/11New drug · Class 1 | ISM8207胶囊 · No verified English nameCXHL2300507 | Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized |
115 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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