YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 427 drug applications between 10 February 2023 and 16 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 112, covering 76 drug names.
2023/02/10 – 2023/02/16
- New acceptances this week
- 427
- Drugs with new generic filings (by drug name, de-duplicated)
- 76
- 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
427filings, 112 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 175 |
| Generic | 112 |
| New drug | 70 |
| Import re-registration | 31 |
| Import | 21 |
| Unspecified | 18 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 330 |
| TCM | 47 |
| Therapeutic biologic | 44 |
| 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
76 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 | Empagliflozin Tablets | 3 | 2 | 18 |
| 4 | Urapidil Hydrochloride Injection | 3 | 2 | 6 |
| 5 | Piperacillin Sodium And Tazobactam Sodium For Injection | 3 | 1 | 5 |
| 6 | Metoprolol Succinate Extended-release Capsules | 3 | 1 | 4 |
| 7 | Sitagliptin Phosphate Tablets | 3 | 1 | 2 |
| 8 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 9 | 地氯雷他定口服溶液 · No verified English name | 2 | 2 | 26 |
| 10 | 复方匹可硫酸钠颗粒 · No verified English name | 2 | 2 | 4 |
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
257 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 | 5 | 3 | 5 |
| 4 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 3 | 0 |
| 5 | Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A | 5 | 1 | 0 |
| 6 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 5 | 1 | 5 |
| 7 | Shijiazhuang Yu Ze Tang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Wu Hu Dao Run Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 3 | 1 |
| 10 | Name not romanized | 4 | 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
113 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2023/02/15Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2300525 | Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized |
| 2023/02/15Generic · Class 3 | Metaraminol Tartrate InjectionCYHS2300524 | Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized |
| 2023/02/15New drug · Class 3.4 | 治疗用卡介苗 · No verified English nameCXSL2300133 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2023/02/15New drug · Class 1 | AL-001眼用注射液 · No verified English nameCXSL2300132 | Beijing An Long Biopharmaceuticals Co., Ltd. romanized |
| 2023/02/15New drug · Class 1 | 注射用重组病毒巨噬细胞炎性蛋白 · No verified English nameCXSL2300131 | Guangzhou Hong Run Bio Technology Co., Ltd. romanized |
| 2023/02/15New drug · Class 2.4 | 结核菌素纯蛋白衍生物 · No verified English nameCXSL2300130 | Chengdu Ke En Bio Technology Co., Ltd. romanized |
| 2023/02/15New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2300129 | Beijing Bei Lai Bio Technology Co., Ltd. romanized; Beijing Bei Lai Pharma Co., Ltd. romanized |
| 2023/02/15New drug · Class 1 | DDCI-01胶囊 · No verified English nameCXHL2300225 | Chongqing Di Kang Er Le Pharmaceutical Co., Ltd. romanized |
| 2023/02/15New drug · Class 1 | DDCI-01胶囊 · No verified English nameCXHL2300224 | Chongqing Di Kang Er Le Pharmaceutical Co., Ltd. romanized |
| 2023/02/15New drug · Class 1 | 注射用RNK05047 · No verified English nameCXHL2300223 | Name not romanized |
| 2023/02/15New drug · Class 2.2 | 利拉鲁肽注射液 · No verified English nameCXHL2300222 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/15New drug · Class 2.2 | 利拉鲁肽注射液 · No verified English nameCXHL2300221 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/14Import · Class 3.1 | Ropeginterferon alfa-2b(P1101)注射液 · No verified English nameJXSS2300016 | PharmaEssentia Corporation; PharmaEssentia Corporation Taichung Plant; PharmaEssentia Biotechnology (Beijing) Company limited |
| 2023/02/14Generic · Class 3 | 复方匹可硫酸钠颗粒 · No verified English nameCYHS2300519 | Suzhou Erye Pharmaceutical Co., Ltd |
| 2023/02/14Generic · Class 3 | Ibuprofen GranulesCYHS2300517 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized |
| 2023/02/14Generic · Class 3 | Metoprolol Succinate Extended-release CapsulesCYHS2300512 | Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2023/02/14Generic · Class 3 | Metoprolol Succinate Extended-release CapsulesCYHS2300511 | Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2023/02/14Generic · Class 3 | Metoprolol Succinate Extended-release CapsulesCYHS2300510 | Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2023/02/14Generic · Class 3 | Vancomycin Hydrochloride For Oral SolutionCYHS2300506 | Jiangxi Qing Feng Pharma Co., Ltd. romanized; Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2023/02/14Generic · Class 3 | Vancomycin Hydrochloride For Oral SolutionCYHS2300505 | Jiangxi Qing Feng Pharma Co., Ltd. romanized; Jiangxi Ke Rui Pharma Co., Ltd. romanized |
83 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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