YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 317 drug applications between 26 June 2025 and 2 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 48 drug names.

2025/06/26 – 2025/07/02

Period
2025/06/26 to 2025/07/02, 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
317
Drugs with new generic filings (by drug name, de-duplicated)
48
Accepted this week, now under review
48

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

317filings, 67 of them generic

By application type

Application typeFilings
Supplement191
Generic67
New drug39
Import re-registration11
Import8
Unspecified1

By drug type

Drug typeFilings
Chemical drug176
TCM96
Therapeutic biologic43
Prophylactic biologic2

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

189 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Jun An Pharma Group Hong Xiang Pharmaceutical Co., Ltd. romanized13130
2Shanxi Hua Kang Pharma Co., Ltd. romanized770
3Pfizer Australia Pty Ltd720
4Guangxi Lai Bin Hu Lu Wa Pharma Co., Ltd. romanized660
5Topfond Pharmaceutical Co., Ltd.651
6Lanzhou Tai Bao Pharmaceutical Co., Ltd. romanized640
7Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized630
8Qilu Pharmaceutical Co., Ltd.530
9Celgene Corporation510
10Da Tong Shi Li Qun Pharma Co., Ltd. romanized440

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

71 this week

AcceptedDrugApplicants
2025/07/02Import · Class 1 AB248 (etakafusp alfa) 注射液 · No verified English nameJXSL2500116 Asher Biotherapeutics Inc.; PAREXEL CHINA CO. LTD
2025/07/02Import · Class 1 AZD2936 · No verified English nameJXSL2500115 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/02Generic · Class 3 Sodium Nitroprusside InjectionCYHS2502341 Sichuan Jian Lin Pharma Co., Ltd. romanized; Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2025/07/02Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2502338 Anhui Mei Lai Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized
2025/07/02Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2502334 Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2025/07/02Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2502333 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2025/07/02Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2502332 Guo Yue (Shandong) Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/07/02Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2502331 Guo Yue (Shandong) Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/07/02New drug · Class 1 个性化树突状细胞注射液 · No verified English nameCXSL2500532 Zhong Sheng Kang Yuan Bio Technology (Beijing) Co., Ltd. romanized
2025/07/02New drug · Class 1 个性化树突状细胞注射液 · No verified English nameCXSL2500531 Zhong Sheng Kang Yuan Bio Technology (Beijing) Co., Ltd. romanized
2025/07/02New drug · Class 1 个性化树突状细胞注射液 · No verified English nameCXSL2500530 Zhong Sheng Kang Yuan Bio Technology (Beijing) Co., Ltd. romanized
2025/07/02New drug · Class 1 BBT002注射液 · No verified English nameCXSL2500529 Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/02New drug · Class 1 BBT002注射液 · No verified English nameCXSL2500528 Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/02New drug · Class 2.2; 2.4 JW202313吸入粉雾剂 · No verified English nameCXHL2500632 Jewim Pharmaceutical (Shandong) Co., Ltd.
2025/07/02New drug · Class 1 SH3765片 · No verified English nameCXHL2500631 Nanjing Sheng He Pharma Co., Ltd. romanized
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.

41 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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