YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 478 drug applications between 11 February 2023 and 17 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 129, covering 87 drug names.
2023/02/11 – 2023/02/17
- New acceptances this week
- 478
- Drugs with new generic filings (by drug name, de-duplicated)
- 87
- 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
478filings, 129 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 200 |
| Generic | 129 |
| New drug | 74 |
| Import re-registration | 31 |
| Import | 25 |
| Unspecified | 19 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 366 |
| TCM | 56 |
| Therapeutic biologic | 50 |
| Prophylactic biologic | 5 |
| 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
87 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Gadoteric Acid Meglumine Salt Injection | 5 | 1 | 1 |
| 2 | Oxycodone Hydrochloride and Naloxone Hydrochloride Prolonged-release Tablets | 4 | 1 | 3 |
| 3 | 瑞巴派特片 · No verified English name | 3 | 3 | 4 |
| 4 | Lactulose Oral Solution | 3 | 2 | 34 |
| 5 | Empagliflozin Tablets | 3 | 2 | 18 |
| 6 | Urapidil Hydrochloride Injection | 3 | 2 | 6 |
| 7 | Piperacillin Sodium And Tazobactam Sodium For Injection | 3 | 1 | 5 |
| 8 | Metoprolol Succinate Extended-release Capsules | 3 | 1 | 4 |
| 9 | Sitagliptin Phosphate Tablets | 3 | 1 | 2 |
| 10 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
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
289 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Name not romanized | 9 | 7 | 0 |
| 2 | NAPP PHARMACEUTICALS LIMITED | 9 | 1 | 0 |
| 3 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 6 | 4 | 5 |
| 4 | Pfizer Inc. | 6 | 2 | 0 |
| 5 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 6 | 2 | 6 |
| 6 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 3 | 0 |
| 7 | Jiangsu Hui Ju Pharma Co., Ltd. romanized | 5 | 3 | 1 |
| 8 | Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A | 5 | 1 | 0 |
| 9 | Shijiazhuang Yu Ze Tang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Wu Hu Dao Run Pharma Co., Ltd. romanized | 4 | 4 | 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
131 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/02/17Import · Class 1 | PF-07220060 · No verified English nameJXHL2300027 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2023/02/17Import · Class 1 | PF-07220060 · No verified English nameJXHL2300026 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2023/02/17Import · Class 1 | PF-07248144片 · No verified English nameJXHL2300025 | 235 East 42nd Street New York N.Y. 10017 USA; Pfizer Investment CO. Ltd. |
| 2023/02/17Import · Class 1 | PF-07248144片 · No verified English nameJXHL2300024 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2023/02/17Generic · Class 3 | Mannitol-S InjectionCYHS2300551 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2023/02/17Generic · Class 3 | Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2300548 | Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/02/17Generic · Class 3 | Acyclovir Sodium InjectionCYHS2300547 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized |
| 2023/02/17Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2300546 | Shanxi Pu De Pharma Co., Ltd. romanized |
| 2023/02/17Generic · Class 3 | Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2300545 | Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/02/17Generic · Class 3 | Pentoxifylline InjectionCYHS2300543 | Jiangsu Hui Ju Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2023/02/17Generic · Class 3 | Amoxicillin Sodium for InjectionCYHS2300540 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2023/02/17Generic · Class 3 | Amoxicillin Sodium for InjectionCYHS2300539 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2023/02/17Generic · Class 3 | Elagolix TabletsCYHL2300022 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2023/02/17Generic · Class 3 | Elagolix TabletsCYHL2300021 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2023/02/17New drug · Class 2.3 | 儿童小柴胡颗粒 · No verified English nameCXZL2300011 | Guangzhou Bai Yun Shan Guang Hua Pharmaceutical Co., Ltd. romanized |
| 2023/02/17New drug · Class 1 | SHR-1905注射液 · No verified English nameCXSL2300139 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/02/17New drug · Class 1 | BM012注射液 · No verified English nameCXSL2300138 | Suzhou Bo Ao Ming Sai Biopharmaceutical Co., Ltd. romanized |
| 2023/02/17New drug · Class 1 | 重组抗PD-L1和TGF-β双功能融合蛋白注射液 · No verified English nameCXSL2300137 | Hua Lan Ji Yin Gong Cheng (Henan) Co., Ltd. romanized |
| 2023/02/17New drug · Class 2.4 | 氢溴酸氘瑞米德韦干混悬剂 · No verified English nameCXHL2300228 | Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhongguo Ke College Wuhan Bing Du Research Institute romanized |
| 2023/02/17New drug · Class 2.4 | 氢溴酸氘瑞米德韦干混悬剂 · No verified English nameCXHL2300227 | Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhongguo Ke College Wuhan Bing Du Research Institute romanized |
| 2023/02/16Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2300537 | Sichuan He Zong Ze Hui Pharmaceuticals Technology Co., Ltd. romanized; Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2023/02/16Generic · Class 3 | Mannitol-S InjectionCYHS2300536 | Hubei Xin Ze Fei Pharma Co., Ltd. romanized; Hubei Hua Ren Tong Ji Pharma Co., Ltd. romanized |
| 2023/02/16Generic · Class 3 | Ornidazole InjectionCYHS2300531 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2023/02/16Generic · Class 3 | Ornidazole InjectionCYHS2300530 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2023/02/16Generic · Class 3 | Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2300526 | Zhejiang Nord Pharmaceutical Co., Ltd |
| 2023/02/16New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2300136 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2023/02/16New drug · Class 1 | 注射用MR001双特异性抗体 · No verified English nameCXSL2300135 | Shenzhen Shi Mai Jia Rui Bio Technology Co., Ltd. romanized |
| 2023/02/16New drug · Class 1 | 注射用PRO1160 · No verified English nameCXSL2300134 | Pu Fang Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2023/02/16New drug · Class 1 | PG-011凝胶 · No verified English nameCXHL2300226 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/15Import · Class 2.4 | Inclisiran注射液 · No verified English nameJXHL2300023 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
101 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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