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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 378 drug applications between 2 April 2025 and 8 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 104, covering 73 drug names.

2025/04/02 – 2025/04/08

Period
2025/04/02 to 2025/04/08, 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
378
Drugs with new generic filings (by drug name, de-duplicated)
73
Accepted this week, now under review
25

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

378filings, 104 of them generic

By application type

Application typeFilings
Supplement199
Generic104
New drug43
Import21
Unspecified7
Import re-registration4

By drug type

Drug typeFilings
Chemical drug217
TCM103
Therapeutic biologic56
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

73 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets5223
2Brexpiprazole Tablets4231
3Vonoprazan Fumarate Tablets3260
4Oxacillin Sodium for Injection3113
5Letermovir Injection226
6维生素B6注射液 · No verified English name2210
7低钙腹膜透析液(乳酸盐-G1.5%) · No verified English name213
8低钙腹膜透析液(乳酸盐-G2.5%) · No verified English name214
9低钙腹膜透析液(乳酸盐-G4.25%) · No verified English name213
10Dexketoprofen Trometamol Tablets210

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

213 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shaanxi Pan Long Pharma Group Co., Ltd. romanized13110
2Ningbo Tian Yi Pharma Technology Co., Ltd. romanized12612
3Guo Yao Group Beijing Hua Miao Pharma Co., Ltd. romanized11100
4Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized860
5Shenyang Dong Xin Pharma Co., Ltd. romanized750
6Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized660
7Bayer Inc.610
8Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized550
9Shandong Er Ye Pharmaceutical Co., Ltd. romanized540
10Merck Healthcare KGaA530

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

93 this week

AcceptedDrugApplicants
2025/04/08Import · Class 1 DS-1062a · No verified English nameJXSL2500054 ASTRAZENECA AB; AstraZeneca Investment (China) Co. Limited
2025/04/08Import · Class 2.1 Isatuximab注射液(皮下注射) · No verified English nameJXSL2500053 Sanofi-Aventis Recherche & Développement
2025/04/08Import · Class 1 Imlunestrant 片 · No verified English nameJXHS2500045 Eli Lilly Nederland B.V.; RECIPHARM LEGANéS S.L.U.; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/08Import · Class 1 Imlunestrant片 · No verified English nameJXHS2500044 Eli Lilly Nederland B.V.; RECIPHARM LEGANéS S.L.U.; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/08Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2501354 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/04/08Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2501353 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/04/08Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2501336 Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized; Hangzhou Qian Yuan Bao Ling Pharma Co., Ltd. romanized
2025/04/08Generic · Class 3 Sodium Lactate Ringer's Irrigation SolutionCYHS2501332 Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2025/04/08Generic · Class 3 Voglibose Orally Dispersing TabletsCYHS2501331 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2025/04/08Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2501328 Anhui Pioneer Pharmaceutical Co., Ltd
2025/04/08Generic · Class 3 苯磺酸氨氯地平口服溶液 · No verified English nameCYHS2501327 Shandong Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized
2025/04/08Generic · Class 3 Oxacillin Sodium for InjectionCYHS2501324 Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized
2025/04/08Generic · Class 3 Oxacillin Sodium for InjectionCYHS2501323 Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized
2025/04/08Generic · Class 3 Oxacillin Sodium for InjectionCYHS2501322 Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized
2025/04/08Generic · Class 3 Peramivir InjectionCYHS2501319 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2025/04/08Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2501318 Guangdong Rui Xing Pharmaceuticals Co., Ltd. romanized; Dong Guan Shi Jin Mei Ji Pharma Co., Ltd. romanized
2025/04/08Generic · Class 3 Sodium sulfate, magnesium sulfate, and potassium chloride TabletsCYHL2500075 Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized
2025/04/08New drug · Class 2.2 冻干人用狂犬病疫苗(无血清Vero细胞) · No verified English nameCXSS2500044 Ai Mei Rong Yu (Ningbo) Biopharmaceutical Co., Ltd. romanized
2025/04/08New drug · Class 1 注射用ZG006 · No verified English nameCXSL2500279 Name not romanized; Name not romanized
2025/04/08New drug · Class 1 注射用ZG005 · No verified English nameCXSL2500278 Name not romanized; Name not romanized
2025/04/08New drug · Class 3.2 人凝血因子Ⅸ · No verified English nameCXSL2500277 Yuan Da Shu Yang Sheng Ming Ke Xue (Chengdu) Co., Ltd. romanized
2025/04/08New drug · Class 1 JD012-CEL注射液 · No verified English nameCXSL2500276 Beijing Jing Da Bio Technology Co., Ltd. romanized; Guangzhou Xi Ling Bio Technology Co., Ltd. romanized
2025/04/08New drug · Class 1 KM1溶瘤痘苗病毒注射液 · No verified English nameCXSL2500274 Shenzhen Shi Hua Yao Kang Ming Bio Pharma Co., Ltd. romanized
2025/04/08New drug · Class 1 KSD-101注射液 · No verified English nameCXSL2500273 Zhong Shan Heng Sai Bio Technology Co., Ltd. romanized
2025/04/08New drug · Class 1 注射用LY4101174 · No verified English nameCXSL2500272 Li Lai Suzhou Pharmaceutical Co., Ltd. romanized
2025/04/08New drug · Class 1 IGP-14068-TM片 · No verified English nameCXHL2500361 Hangzhou Ying Chuang Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Mei Di Xi Biopharmaceuticals Co., Ltd. romanized
2025/04/08New drug · Class 1 IGP-14068-TM片 · No verified English nameCXHL2500360 Hangzhou Ying Chuang Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Mei Di Xi Biopharmaceuticals Co., Ltd. romanized
2025/04/08New drug · Class 1 177Lu-NRT6020注射液 · No verified English nameCXHL2500359 Chengdu Niu Rui Te Medical Technology Co., Ltd. romanized
2025/04/07Import · Class 2.4 英克司兰钠注射液 · No verified English nameJXHS2500043 Novartis Europharm Limited; Novartis Pharmaceutical Manufacturing GmbH; Beijing Novartis Pharma Co. Ltd.
2025/04/07Import · Class 1 Lartesertib片剂 · No verified English nameJXHL2500071 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd

63 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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