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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 324 drug applications between 22 June 2025 and 28 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 58 drug names.

2025/06/22 – 2025/06/28

Period
2025/06/22 to 2025/06/28, 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
324
Drugs with new generic filings (by drug name, de-duplicated)
58
Accepted this week, now under review
53

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

324filings, 80 of them generic

By application type

Application typeFilings
Supplement164
Generic80
New drug52
Import re-registration15
Import10
Unspecified3

By drug type

Drug typeFilings
Chemical drug191
TCM85
Therapeutic biologic45
Prophylactic biologic2
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

58 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

217 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Jun An Pharma Group Hong Xiang Pharmaceutical Co., Ltd. romanized13130
2Da Tong Shi Li Qun Pharma Co., Ltd. romanized550
3Shanxi Hua Kang Pharma Co., Ltd. romanized550
4Hunan Tai Yang Pharma Co., Ltd. romanized440
5Topfond Pharmaceutical Co., Ltd.431
6SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED432
7Guangdong He Xiang Biopharmaceuticals Co., Ltd. romanized430
8Roche Pharma (Schweiz) AG420
9Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized410
10Pfizer Inc.330

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

87 this week

AcceptedDrugApplicants
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
2025/06/27New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSS2500070 Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized
2025/06/27New drug · Class 1 注射用QLC5508 · No verified English nameCXSL2500519 Qilu Pharmaceutical Co., Ltd.
2025/06/27New drug · Class 2.2 培集成干扰素α-2注射液 · No verified English nameCXSL2500518 Beijing Kai Yin Technology Co., Ltd. romanized
2025/06/27New drug · Class 1 QLH12016胶囊 · No verified English nameCXHL2500625 Qilu Pharmaceutical Co., Ltd.
2025/06/27New drug · Class 1 QLH12016胶囊 · No verified English nameCXHL2500624 Qilu Pharmaceutical Co., Ltd.
2025/06/27New drug · Class 1 ICP-332片 · No verified English nameCXHL2500621 Guangzhou Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2025/06/26Import · Class 3.1 注射用A型肉毒毒素 · No verified English nameJXSS2500098 AbbVie Limited; Allergan Pharmaceuticals Ireland; Allergan Information Consulting (Shanghai) Co. Ltd.
2025/06/26Import · Class 3.1 注射用A型肉毒毒素 · No verified English nameJXSS2500097 AbbVie Limited; Allergan Pharmaceuticals Ireland; Allergan Information Consulting (Shanghai) Co. Ltd.
2025/06/26Import · Class 3.1 注射用A型肉毒毒素 · No verified English nameJXSS2500096 AbbVie Limited; Allergan Pharmaceuticals Ireland; Allergan Information Consulting (Shanghai) Co. Ltd.
2025/06/26Generic · Class 3 Paracetamol and Ibuprofen TabletsCYHS2502290 Jian Min Pharma Group Co., Ltd. romanized

57 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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