YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 361 drug applications between 14 February 2023 and 20 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 98, covering 68 drug names.
2023/02/14 – 2023/02/20
- New acceptances this week
- 361
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- Accepted this week, now under review
- 0
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
361filings, 98 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 166 |
| Generic | 98 |
| New drug | 48 |
| Import re-registration | 26 |
| Import | 16 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 268 |
| TCM | 52 |
| Therapeutic biologic | 39 |
| Biologic | 1 |
| 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 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 4 | 3 | 23 |
| 2 | Lidocaine and Prilocaine Cream | 3 | 3 | 24 |
| 3 | Lactulose Oral Solution | 3 | 2 | 34 |
| 4 | Tranexamic Acid Injection | 3 | 1 | 11 |
| 5 | Metoprolol Succinate Extended-release Capsules | 3 | 1 | 4 |
| 6 | 复方匹可硫酸钠颗粒 · No verified English name | 2 | 2 | 4 |
| 7 | 氧 · No verified English name | 2 | 2 | 15 |
| 8 | Roxatidine Acetate Hydrochloride For Injection | 2 | 2 | 5 |
| 9 | 瑞巴派特片 · No verified English name | 2 | 2 | 4 |
| 10 | Mannitol-S Injection | 2 | 2 | 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
229 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Name not romanized | 9 | 7 | 0 |
| 2 | An Qing Hui Yin Bi Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 3 | NAPP PHARMACEUTICALS LIMITED | 6 | 1 | 0 |
| 4 | Shijiazhuang Yu Ze Tang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 4 | 2 |
| 6 | Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Bai Yin Zhen Ya Wei Sheng Cai Liao Co., Ltd. romanized | 4 | 3 | 0 |
| 8 | Actelion Pharmaceuticals Ltd | 4 | 1 | 0 |
| 9 | BIOTON S.A. | 4 | 1 | 0 |
| 10 | Novartis Pharma Schweiz AG | 4 | 1 | 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
98 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/02/20New drug · Class 1 | ZT002注射液 · No verified English nameCXSL2300142 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/20New drug · Class 2.4 | 替戈拉生片 · No verified English nameCXHS2300034 | Shandong Luo Xin Pharma Group Co., Ltd. romanized |
| 2023/02/18Import · Class 2.3 | IBD98-M缓释胶囊 · No verified English nameJXHL2300028 | Holy Stone Healthcare Co. Ltd.; Clinical Service Center Co. Ltd |
| 2023/02/18Generic · Class 3 | Methotrexate TabletsCYHS2300574 | Jiangsu Bai Ao Xin Kang Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized |
| 2023/02/18Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300572 | Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized |
| 2023/02/18Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300568 | Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jiangsu Yun Yang Group Pharma Co., Ltd. romanized |
| 2023/02/18Generic · Class 3 | Levetiracetam extended-release tabletsCYHS2300567 | Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized |
| 2023/02/18Generic · Class 3 | Levetiracetam extended-release tabletsCYHS2300565 | Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized |
| 2023/02/18Generic · Class 3 | Isoniazid InjectionCYHS2300564 | Hubei Mei Lin Pharma Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized |
| 2023/02/18Generic · Class 3 | Indocyaninegreen for InjectionCYHS2300560 | Nanjing Ya Dong Qi Tian Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/02/18Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300557 | Hubei Wu Shi Pharmaceuticals Research Institute Co., Ltd. romanized; Hubei Wu Shi Pharma Co., Ltd. romanized |
| 2023/02/18Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300556 | Hubei Wu Shi Pharmaceuticals Research Institute Co., Ltd. romanized; Hubei Wu Shi Pharma Co., Ltd. romanized |
| 2023/02/18Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2300554 | Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2023/02/18New drug · Class 1 | 个性化树突状细胞注射液 · No verified English nameCXSL2300141 | Zhong Sheng Kang Yuan Bio Technology (Beijing) Co., Ltd. romanized |
| 2023/02/18New drug · Class 1 | 注射用人源抗IL-17A单克隆抗体冻干粉针 · No verified English nameCXSL2300140 | Shandong Fang Tan Si Biopharmaceutical Co., Ltd. romanized |
| 2023/02/18New drug · Class 2.3 | 盐酸左旋沙丁胺醇异丙托溴铵雾化吸入溶液 · No verified English nameCXHL2300232 | Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized |
| 2023/02/18New drug · Class 1 | AC-003胶囊 · No verified English nameCXHL2300231 | Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2023/02/18New drug · Class 1 | AC-003胶囊 · No verified English nameCXHL2300230 | Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2023/02/18New drug · Class 1 | SHR7280干混悬剂 · No verified English nameCXHL2300229 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 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 |
68 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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