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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 365 drug applications between 13 February 2023 and 19 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 101, covering 67 drug names.

2023/02/13 – 2023/02/19

Period
2023/02/13 to 2023/02/19, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
365
Drugs with new generic filings (by drug name, de-duplicated)
67
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

365filings, 101 of them generic

By application type

Application typeFilings
Supplement167
Generic101
New drug52
Import re-registration22
Import16
Unspecified7

By drug type

Drug typeFilings
Chemical drug268
TCM52
Therapeutic biologic40
Prophylactic biologic4
Biologic1

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

67 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Gadoteric Acid Meglumine Salt Injection511
2Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution4323
3Lidocaine and Prilocaine Cream3324
4Lactulose Oral Solution3234
5Tranexamic Acid Injection3111
6Metoprolol Succinate Extended-release Capsules314
7复方匹可硫酸钠颗粒 · No verified English name224
8氧 · No verified English name2215
9Roxatidine Acetate Hydrochloride For Injection225
10瑞巴派特片 · No verified English name224

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)FilingsDrugsGeneric
1Name not romanized970
2An Qing Hui Yin Bi Pharmaceutical Co., Ltd. romanized650
3Hainan Pu Li Pharmaceutical Co., Ltd. romanized626
4NAPP PHARMACEUTICALS LIMITED610
5Shijiazhuang Yu Ze Tang Pharmaceutical Co., Ltd. romanized550
6Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized440
7Bai Yin Zhen Ya Wei Sheng Cai Liao Co., Ltd. romanized430
8Shijiazhuang No.4 Pharmaceutical Co., Ltd.431
9Actelion Pharmaceuticals Ltd410
10BIOTON S.A.410

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

102 this week

AcceptedDrugApplicants
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
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.

72 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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