YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 326 drug applications between 5 March 2023 and 11 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 54 drug names.
2023/03/05 – 2023/03/11
- New acceptances this week
- 326
- Drugs with new generic filings (by drug name, de-duplicated)
- 54
- Accepted this week, now under review
- 9
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
326filings, 73 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 174 |
| Generic | 73 |
| New drug | 46 |
| Import | 13 |
| Import re-registration | 12 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 242 |
| TCM | 44 |
| Therapeutic biologic | 35 |
| Biologic | 3 |
| Prophylactic biologic | 2 |
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
54 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Famotidine Injection | 3 | 3 | 8 |
| 2 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 3 | 2 | 23 |
| 3 | Minoxidil Topical Solution | 3 | 2 | 0 |
| 4 | Palbociclib Capsules | 3 | 1 | 0 |
| 5 | Risperidone Orally Disintegrating Tablets | 2 | 1 | 0 |
| 6 | 吸入用布地奈德混悬液 · No verified English name | 2 | 1 | 7 |
| 7 | Dimethyl Fumarate Delayed-release Capsules | 2 | 1 | 0 |
| 8 | Empagliflozin And Linagliptin Tablets | 2 | 1 | 0 |
| 9 | Torsemide Injection | 2 | 1 | 1 |
| 10 | Dexrazoxane for Injection | 2 | 1 | 1 |
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
188 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Tianjin He Zhi Pharma Group Co., Ltd. romanized | 8 | 8 | 0 |
| 2 | Shanghai Qing Ping Pharma Co., Ltd. romanized | 8 | 5 | 0 |
| 3 | Actelion Pharmaceuticals Ltd | 8 | 1 | 0 |
| 4 | Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 7 | 6 | 0 |
| 5 | Hong Xiang (Heilongjiang) Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Shandong Run Ze Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Eurofins Analytical Science Laboratories Inc. | 5 | 5 | 0 |
| 8 | Bo Zhou Ya Ying Pharmaceuticals Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 5 | 5 | 1 |
| 10 | Guangzhou Bai Yun Shan Tian Xin Pharmaceutical Co., Ltd. romanized | 5 | 3 | 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
90 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/03/11Import · Class 3.1 | 度伐利尤单抗注射液 · No verified English nameJXSS2300025 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2023/03/11Import · Class 3.1 | 度伐利尤单抗注射液 · No verified English nameJXSS2300024 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2023/03/11Import · Class 1 | elranatamab · No verified English nameJXSL2300049 | Pfizer Inc; Pfizer Investment CO. Ltd. |
| 2023/03/11Import · Class 1 | Zavegepant鼻喷雾剂 · No verified English nameJXHL2300044 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2023/03/11Generic · Class 3 | Empagliflozin And Linagliptin TabletsCYHS2300770 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2023/03/11Generic · Class 3 | Empagliflozin And Linagliptin TabletsCYHS2300769 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2023/03/11Generic · Class 3 | Famotidine InjectionCYHS2300763 | Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2023/03/11New drug · Class 1 | HH-012注射液 · No verified English nameCXSL2300182 | Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized |
| 2023/03/11New drug · Class 2.4 | Fulvestrant InjectionCXHL2300302 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/03/11New drug · Class 2.4 | Fulvestrant InjectionCXHL2300301 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/03/11New drug · Class 1 | 替拉扎明注射液 · No verified English nameCXHL2300300 | Hangzhou Rui Zhen Pharmaceuticals Co., Ltd. romanized |
| 2023/03/11New drug · Class 1 | VC004凝胶 · No verified English nameCXHL2300299 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/03/11New drug · Class 1 | VC004凝胶 · No verified English nameCXHL2300298 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/03/11New drug · Class 1 | VC004凝胶 · No verified English nameCXHL2300297 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/03/11New drug · Class 1 | VC004凝胶 · No verified English nameCXHL2300296 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/03/11New drug · Class 1 | NRT6008注射液 · No verified English nameCXHL2300295 | Chengdu Niu Rui Te Medical Technology Co., Ltd. romanized |
| 2023/03/10Import · Class 3.1 | 注射用维恩妥尤单抗 · No verified English nameJXSS2300023 | Astellas Pharma Europe B.V.; Baxter Oncology GmbH; Astellas (China) Investment Co. Ltd. |
| 2023/03/10Import · Class 3.1 | 注射用维恩妥尤单抗 · No verified English nameJXSS2300022 | Astellas Pharma Europe B.V.; Baxter Oncology GmbH; Astellas (China) Investment Co Ltd. |
| 2023/03/10Generic · Class 3 | Famotidine InjectionCYHS2300762 | Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized |
| 2023/03/10Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2300761 | Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized |
| 2023/03/10Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2300760 | Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized |
| 2023/03/10Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2300759 | Tong Hua Wan Tong Pharma Co., Ltd. romanized |
| 2023/03/10Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2300758 | Tong Hua Wan Tong Pharma Co., Ltd. romanized |
| 2023/03/10Generic · Class 3 | Oxaliplatin InjectionCYHS2300754 | Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized |
| 2023/03/10Generic · Class 3 | Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2300753 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2023/03/10New drug · Class 1 | 恩朗苏拜单抗注射液 · No verified English nameCXSS2300010 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2023/03/10New drug · Class 1 | EA5注射液 · No verified English nameCXSL2300180 | Suzhou Bo Wei Bio Technology Co., Ltd. romanized; Shanghai Lan Yi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/03/10New drug · Class 1 | HS-20117注射液 · No verified English nameCXSL2300179 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2023/03/10New drug · Class 2.2 | 他达拉非口腔速溶膜 · No verified English nameCXHS2300037 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2023/03/10New drug · Class 1 | WT-1108片 · No verified English nameCXHL2300294 | Hangzhou Wei Tan Pharmaceuticals Technology Co., Ltd. romanized |
60 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.