YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 347 drug applications between 10 April 2025 and 16 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 67 drug names.

2025/04/10 – 2025/04/16

Period
2025/04/10 to 2025/04/16, 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
347
Drugs with new generic filings (by drug name, de-duplicated)
67
Accepted this week, now under review
38

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

347filings, 97 of them generic

By application type

Application typeFilings
Supplement170
Generic97
New drug55
Import19
Unspecified4
Import re-registration2

By drug type

Drug typeFilings
Chemical drug231
TCM63
Therapeutic biologic47
Prophylactic biologic5
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

67 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets5270
2Dapagliflozin Tablets4284
3Cefotaxime Sodium For Injection4114
4达普司他片 · No verified English name410
5复方聚乙二醇(3350)电解质散 · No verified English name323
6Finerenone Tablets3269
7Ampicillin Sodium For Injection315
8Upadacitinib Sustained-release Tablets2243
9氟比洛芬凝胶贴膏 · No verified English name2216
10Iron Proteinsuccinylate Oral Solution2226

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

226 companies with new acceptances; top 10 listed

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

109 this week

AcceptedDrugApplicants
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.
2025/04/16Import · Class 1 BMS-986435片 · No verified English nameJXHL2500086 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/04/16Import · Class 1 BMS-986435片 · No verified English nameJXHL2500085 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/04/16Import · Class 1 BMS-986435片 · No verified English nameJXHL2500084 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/04/16Import · Class 2.4 Olaparib TabletsJXHL2500083 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/04/16Import · Class 2.4 Olaparib TabletsJXHL2500082 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/04/16Generic · Class 3 Deferasirox GranulesCYHS2501457 Xian Nuo Da Xin Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd
2025/04/16Generic · Class 3 Deferasirox GranulesCYHS2501455 Xian Nuo Da Xin Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd
2025/04/16Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2501449 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/04/16Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2501448 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/04/16Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2501446 Chengdu Giantech Hi-technology Development Co., Ltd.; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2025/04/16Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2501445 Chengdu Giantech Hi-technology Development Co., Ltd.; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2025/04/16Generic · Class 3 Cefotaxime Sodium For InjectionCYHS2501443 Guangdong Yue He Ze Drug Research Co., Ltd. romanized; Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized
2025/04/16Generic · Class 3 Cefotaxime Sodium For InjectionCYHS2501442 Guangdong Yue He Ze Drug Research Co., Ltd. romanized; Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized
2025/04/16Generic · Class 3 Cefotaxime Sodium For InjectionCYHS2501441 Guangdong Yue He Ze Drug Research Co., Ltd. romanized; Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized
2025/04/16Generic · Class 3 Cefotaxime Sodium For InjectionCYHS2501440 Guangdong Yue He Ze Drug Research Co., Ltd. romanized; Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized
2025/04/16Generic · Class 3 Sodium Cromoglicate Eye DropsCYHS2501439 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized
2025/04/16Generic · Class 3 达普司他片 · No verified English nameCYHL2500085 Qilu Pharmaceutical (Hainan) Co., Ltd
2025/04/16Generic · Class 3 达普司他片 · No verified English nameCYHL2500084 Qilu Pharmaceutical (Hainan) Co., Ltd
2025/04/16Generic · Class 3 达普司他片 · No verified English nameCYHL2500083 Qilu Pharmaceutical (Hainan) Co., Ltd
2025/04/16Generic · Class 3 达普司他片 · No verified English nameCYHL2500082 Qilu Pharmaceutical (Hainan) Co., Ltd
2025/04/16New drug · Class 2.3 小儿黄金止咳颗粒 · No verified English nameCXZL2500023 Beijing Dong Fang Yun Jia Pharma Co., Ltd. romanized
2025/04/16New drug · Class 1.1 益气活血解郁颗粒 · No verified English nameCXZL2500022 Hangzhou Hong Yu Pharmaceuticals Technology Co., Ltd. romanized
2025/04/16New drug · Class 2.4 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) · No verified English nameCXSL2500309 Suzhou Ruo Yi Bio Technology Co., Ltd. romanized
2025/04/16New drug · Class 1 DMR2301注射液 · No verified English nameCXSL2500308 Shanghai Duo Mi Rui Bio Technology Co., Ltd. romanized
2025/04/16New drug · Class 1 SCTB39G注射液 · No verified English nameCXSL2500307 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2025/04/16New drug · Class 3.3 甘精胰岛素注射液 · No verified English nameCXSL2500306 Yi Fan Pharmaceuticals (Shanghai) Co., Ltd. romanized

79 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.