YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 337 drug applications between 11 April 2025 and 17 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 64 drug names.

2025/04/11 – 2025/04/17

Period
2025/04/11 to 2025/04/17, 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
337
Drugs with new generic filings (by drug name, de-duplicated)
64
Accepted this week, now under review
31

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

337filings, 90 of them generic

By application type

Application typeFilings
Supplement155
Generic90
New drug57
Import17
Import re-registration12
Unspecified4
Drug-device combination2

By drug type

Drug typeFilings
Chemical drug233
TCM54
Therapeutic biologic46
Prophylactic biologic3
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

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets5270
2Cefotaxime Sodium For Injection4114
3达普司他片 · No verified English name410
4复方聚乙二醇(3350)电解质散 · No verified English name323
5Finerenone Tablets3269
6Riociguat Tablets314
7Ampicillin Sodium For Injection315
8Upadacitinib Sustained-release Tablets2243
9氟比洛芬凝胶贴膏 · No verified English name2216
10Deferasirox Granules212

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
1Shenyang Dong Xin Pharma Co., Ltd. romanized850
2AstraZeneca AB750
3Kowa Company Ltd.510
4Sichuan Kelun Pharmaceutical Co., Ltd.510
5Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized510
6Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized440
7Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized421
8AstraZeneca UK Limited410
9Guangdong Yue He Ze Drug Research Co., Ltd. romanized414
10Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized410

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

112 this week

AcceptedDrugApplicants
2025/04/17Generic · Class 3 Calcium Carbonate TabletsCYHS2501473 Zhong He Pharmaceuticals (Hubei) Co., Ltd. romanized; Beijing Bai Mei Te Biopharmaceutical Co., Ltd. romanized
2025/04/17Generic · Class 3 Bumetanide InjectionCYHS2501471 Shandong Hui Cheng Pharma Co., Ltd. romanized
2025/04/17Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2501466 Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2025/04/17Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2501465 Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2025/04/17Generic · Class 3 Indobufen TabletsCYHS2501464 Hunan Qian Jin Xie Li Pharma Co., Ltd. romanized
2025/04/17Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2501463 Hebei Hong Xin Tang Pharma Co., Ltd. romanized; Jiangsu Cheng Kang Pharma Co., Ltd. romanized
2025/04/17Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2501461 Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized
2025/04/17New drug · Class 1 注射用HY05350 · No verified English nameCXSL2500316 Name not romanized
2025/04/17New drug · Class 1 J002 · No verified English nameCXSL2500315 Wen Zhou Yi Ke University romanized; Hua Run Zi Zhu Pharma Co., Ltd. romanized
2025/04/17New drug · Class 1 J002 · No verified English nameCXSL2500314 Wen Zhou Yi Ke University romanized; Hua Run Zi Zhu Pharma Co., Ltd. romanized
2025/04/17New drug · Class 1 YOLT-101注射液 · No verified English nameCXSL2500313 Yao Tang (Nanjing) Bio Technology Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2025/04/17New drug · Class 1 HF158K1 · No verified English nameCXSL2500312 Hangzhou Gao Tian Biopharmaceuticals Co., Ltd. romanized
2025/04/17New drug · Class 1 HFK2 · No verified English nameCXSL2500311 Hangzhou Gao Tian Biopharmaceuticals Co., Ltd. romanized
2025/04/17New drug · Class 1 SSS55注射液 · No verified English nameCXSL2500310 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/04/17New drug · Class 1 PTT-621片 · No verified English nameCXHL2500399 Beijing Yan Ming Bio Technology Co., Ltd. romanized
2025/04/17New drug · Class 1 PTT-621片 · No verified English nameCXHL2500398 Beijing Yan Ming Bio Technology Co., Ltd. romanized
2025/04/17New drug · Class 1 WBD156胶囊 · No verified English nameCXHL2500397 Wei En Bio Technology Co., Ltd. romanized
2025/04/17New drug · Class 1 WBD156胶囊 · No verified English nameCXHL2500396 Wei En Bio Technology Co., Ltd. romanized
2025/04/17New drug · Class 1 WBD156胶囊 · No verified English nameCXHL2500395 Wei En Bio Technology Co., Ltd. romanized
2025/04/17New drug · Class 2.2 CX001缓释片 · No verified English nameCXHL2500394 Chongqing Hua Sen Pharmaceutical Co., Ltd. romanized
2025/04/17New drug · Class 2.2 CX001缓释片 · No verified English nameCXHL2500393 Chongqing Hua Sen Pharmaceutical Co., Ltd. romanized
2025/04/17New drug · Class 2.2 CX001缓释片 · No verified English nameCXHL2500392 Chongqing Hua Sen Pharmaceutical Co., Ltd. romanized
2025/04/17New drug · Class 1 HSK45030分散片 · No verified English nameCXHL2500391 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2025/04/17New drug · Class 1 HSK45030分散片 · No verified English nameCXHL2500390 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2025/04/17New drug · Class 1 102D-6干混悬剂 · No verified English nameCXHL2500389 Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized
2025/04/17New drug · Class 1 BW-20507注射液 · No verified English nameCXHL2500388 Shanghai Bo Wang Pharmaceutical Co., Ltd. romanized
2025/04/16Import · Class 3.4 注射用A型肉毒毒素 · No verified English nameJXSS2500048 inibio co. ltd.; Beijing Yuzhuo Biotechnology Co. Ltd.
2025/04/16Import · Class 3.1 米吉珠单抗注射液 · No verified English nameJXSS2500047 Eli Lilly and Company; BSP Pharmaceuticals S.p.A.; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/16Import · Class 3.1 米吉珠单抗注射液(皮下注射) · No verified English nameJXSS2500046 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/16Import · Class 3.1 米吉珠单抗注射液(皮下注射) · No verified English nameJXSS2500045 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.

82 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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