YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 281 drug applications between 30 March 2023 and 5 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 59, covering 46 drug names.
2023/03/30 – 2023/04/05
- New acceptances this week
- 281
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- Accepted this week, now under review
- 1
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
281filings, 59 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 156 |
| Generic | 59 |
| Import | 26 |
| New drug | 23 |
| Import re-registration | 10 |
| Unspecified | 5 |
| Drug-device combination product | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 202 |
| TCM | 50 |
| Therapeutic biologic | 28 |
| 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
46 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Diprophylline Injection | 2 | 2 | 7 |
| 2 | 氧(液态) · No verified English name | 2 | 2 | 13 |
| 3 | Oseltamivir Phosphate For Oral Suspension | 2 | 2 | 2 |
| 4 | Tadalafil Tablets | 2 | 1 | 23 |
| 5 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 1 | 23 |
| 6 | Potassium Chloride Granules | 2 | 1 | 4 |
| 7 | Thiotepa for Injection | 2 | 1 | 0 |
| 8 | 注射用头孢唑肟钠 · No verified English name | 2 | 1 | 4 |
| 9 | Trimetazidine Dihydrochloride Tablets | 2 | 1 | 0 |
| 10 | Dapoxetine Hydrochloride Tablets | 2 | 1 | 20 |
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
155 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Wuhan Xiang Cao Tang Pharma Co., Ltd. romanized | 25 | 24 | 0 |
| 2 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 6 | 4 | 3 |
| 3 | Eli Lilly and Company | 6 | 1 | 0 |
| 4 | Heilongjiang Hua Xi Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 6 | Celgene Corporation | 5 | 1 | 0 |
| 7 | Chu Xiong He Chuang Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 8 | Novo Nordisk A/S | 4 | 2 | 0 |
| 9 | Xian Sheng Zai Ming Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Chongqing Rui En Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 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
61 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/04/05Import · Class 1 | AMG 451 · No verified English nameJXSL2300064 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2023/04/05Generic · Class 3 | Thiotepa for InjectionCYHS2300983 | Name not romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2023/04/05Generic · Class 3 | Thiotepa for InjectionCYHS2300982 | Name not romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2023/04/05Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2300981 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized |
| 2023/04/05Generic · Class 3 | Polyvinyl Alcohol Eye DropsCYHS2300976 | Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized |
| 2023/04/05Generic · Class 3 | Potassium Chloride GranulesCYHS2300965 | Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; Ji Chuan Pharma Group Co., Ltd. romanized |
| 2023/04/05Generic · Class 3 | Potassium Chloride GranulesCYHS2300964 | Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; Ji Chuan Pharma Group Co., Ltd. romanized |
| 2023/04/05Generic · Class 3 | 阿巴帕肽注射液 · No verified English nameCYHL2300044 | Chengdu Guo Wei Biopharmaceuticals Co., Ltd. romanized |
| 2023/04/05New drug · Class 2.2 | 舒格利单抗注射液 · No verified English nameCXSS2300016 | Hui Rui Investment Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized |
| 2023/04/05New drug · Class 3.2 | C1酯酶抑制剂 · No verified English nameCXSL2300226 | Hua Run Bo Ya Biopharmaceutical Group Co., Ltd. romanized |
| 2023/04/04Import · Class 2.4 | 达罗他胺片 · No verified English nameJXHL2300075 | Bayer HealthCare Pharmaceuticals Inc.; Bayer Healthcare Company Ltd. |
| 2023/04/04Generic · Class 3 | Pentoxifylline InjectionCYHS2300961 | Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized |
| 2023/04/04Generic · Class 3 | Minoxidil Topical SolutionCYHS2300960 | Shenzhen Shi Lang Bo Biopharmaceuticals Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd. |
| 2023/04/04Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2300958 | Beijing Si Li An Pharma Co., Ltd. romanized |
| 2023/04/04Generic · Class 3 | Multiple Electrolyte Additive For InjectionCYHS2300956 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/04/04Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2300954 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2023/04/04Generic · Class 3 | 聚乙二醇钠钾散 · No verified English nameCYHS2300952 | Ji Chuan Pharma Group Co., Ltd. romanized |
| 2023/04/04New drug · Class 1 | SENL101自体T细胞注射液 · No verified English nameCXSL2300225 | Hebei Sen Lang Bio Technology Co., Ltd. romanized |
| 2023/04/04New drug · Class 1 | 伊鲁阿克片 · No verified English nameCXHS2300042 | Qilu Pharmaceutical Co., Ltd. |
| 2023/04/04New drug · Class 1 | 伊鲁阿克片 · No verified English nameCXHS2300041 | Qilu Pharmaceutical Co., Ltd. |
| 2023/04/04New drug · Class 1 | CB06-036 · No verified English nameCXHL2300353 | Shanghai Zhi Meng Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/04New drug · Class 1 | CB06-036 · No verified English nameCXHL2300352 | Shanghai Zhi Meng Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/03Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300951 | Hefei Guo Gao Pharma Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized |
| 2023/04/03Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300950 | Hefei Guo Gao Pharma Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized |
| 2023/04/03New drug · Class 1 | TQH2929注射液 · No verified English nameCXSL2300224 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/04/01Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2300032 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2023/04/01Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2300031 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2023/04/01Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2300030 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2023/04/01Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2300029 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2023/04/01Generic · Class 3 | Pirfenidone TabletsCYHS2300947 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized |
31 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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