YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 295 drug applications between 25 June 2025 and 1 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 63, covering 48 drug names.

2025/06/25 – 2025/07/01

Period
2025/06/25 to 2025/07/01, 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
295
Drugs with new generic filings (by drug name, de-duplicated)
48
Accepted this week, now under review
45

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

295filings, 63 of them generic

By application type

Application typeFilings
Supplement173
Generic63
New drug34
Import re-registration15
Import7
Unspecified3

By drug type

Drug typeFilings
Chemical drug166
TCM85
Therapeutic biologic42
Biologic1
Prophylactic 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

48 drugs with new generic filings; top 10 listed

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

190 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Jun An Pharma Group Hong Xiang Pharmaceutical Co., Ltd. romanized13130
2Topfond Pharmaceutical Co., Ltd.651
3Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized630
4Shanxi Hua Kang Pharma Co., Ltd. romanized550
5Qilu Pharmaceutical Co., Ltd.530
6Da Tong Shi Li Qun Pharma Co., Ltd. romanized440
7Lanzhou Tai Bao Pharmaceutical Co., Ltd. romanized430
8Guangdong He Xiang Biopharmaceuticals Co., Ltd. romanized430
9Shen Wei Pharma Group Co., Ltd. romanized430
10Pfizer Australia Pty Ltd420

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

61 this week

AcceptedDrugApplicants
2025/07/01Generic · Class 3 硫酸特布他林口服溶液 · No verified English nameCYHS2502326 Zhengzhou Da Ruo Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2025/07/01New drug · Class 1.1 小儿便通颗粒 · No verified English nameCXZS2500026 Ji Chuan Pharma Group Co., Ltd. romanized
2025/07/01New drug · Class 1 HF001脐带间充质干细胞注射液 · No verified English nameCXSL2500527 Beijing Heng Feng Ming Cheng Bio Technology Co., Ltd. romanized
2025/07/01New drug · Class 2.2 舒格利单抗注射液 · No verified English nameCXSL2500526 Ji Shi Pharma (Suzhou) Co., Ltd. romanized
2025/07/01New drug · Class 1 注射用CS5001 · No verified English nameCXSL2500525 Ji Shi Pharma (Suzhou) Co., Ltd. romanized
2025/07/01New drug · Class 1 9MW4611注射液 · No verified English nameCXSL2500524 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2025/07/01New drug · Class 1 JAB-8263片 · No verified English nameCXHL2500630 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2025/07/01New drug · Class 1 JAB-8263片 · No verified English nameCXHL2500629 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2025/06/30Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2502325 Tong Hua Wan Tong Pharma Co., Ltd. romanized
2025/06/30New drug · Class 1 注射用DXC014 · No verified English nameCXSL2500523 Hangzhou Duo Xi Bio Technology Co., Ltd. romanized
2025/06/28Import · Class 1 PF-07868489 · No verified English nameJXSL2500114 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/06/28Import · Class 1 VAY736注射液 · No verified English nameJXSL2500113 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/06/28Generic · Class 3 Pregabalin Extended release TabletsCYHS2502317 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/06/28Generic · Class 3 Pregabalin Extended release TabletsCYHS2502316 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/06/28Generic · Class 3 Pregabalin Extended release TabletsCYHS2502315 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/06/28Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide Tablets(II)CYHS2502312 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/06/28Generic · Class 3 坎地沙坦酯氢氯噻嗪片(Ⅰ) · No verified English nameCYHS2502311 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/06/28Generic · Class 3 Lidocaine and Tetracaine CreamCYHS2502305 Zhejiang Fu Nuo Pharmaceuticals Co., Ltd. romanized
2025/06/28Generic · Class 3 Relugolix TabletsCYHL2500122 Chengdu Brilliant Pharmaceutical Co., Ltd.
2025/06/28New drug · Class 1.1 补肾痹通丸 · No verified English nameCXZL2500042 Xinjiang Wei Wu Er Zi Zhi Qu Zhong Yi Hospital romanized
2025/06/28New drug · Class 1 重组乙型肝炎治疗性疫苗 · No verified English nameCXSL2500522 Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized
2025/06/28New drug · Class 1 重组乙型肝炎治疗性疫苗 · No verified English nameCXSL2500521 Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized
2025/06/28New drug · Class 1 注射用MHB048C · No verified English nameCXSL2500520 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2025/06/28New drug · Class 1 ALK2401片 · No verified English nameCXHL2500628 Ai Li Kang (Hefei) Pharmaceuticals Technology Co., Ltd. romanized
2025/06/28New drug · Class 1 ALK2401片 · No verified English nameCXHL2500627 Ai Li Kang (Hefei) Pharmaceuticals Technology Co., Ltd. romanized
2025/06/28New drug · Class 1 64Cu-TR2205注射液 · No verified English nameCXHL2500626 Tong Rui Biopharmaceutical (Chengdu) Co., Ltd. romanized
2025/06/27Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2502300 Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized; Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized
2025/06/27Generic · Class 3 Amisulpride Oral SolutionCYHS2502294 Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2025/06/27Generic · Class 3 Ebastine Oral SolutionCYHS2502291 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2025/06/27New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSS2500071 Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized

31 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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