YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 357 drug applications between 24 March 2025 and 30 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 88, covering 60 drug names.

2025/03/24 – 2025/03/30

Period
2025/03/24 to 2025/03/30, 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
357
Drugs with new generic filings (by drug name, de-duplicated)
60
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

357filings, 88 of them generic

By application type

Application typeFilings
Supplement186
Generic88
New drug46
Import28
Import re-registration6
Unspecified3

By drug type

Drug typeFilings
Chemical drug250
Therapeutic biologic52
TCM51
Prophylactic biologic4

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

60 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Glucosamine Sulfate Capsules4451
2Upadacitinib Sustained-release Tablets4243
3Sodium Nitroprusside Injection3315
4Paliperidone Palmitate Injection318
5Sacubitril Valsartan Sodium Tablets3170
6Polidocanol Injection3123
7Ferrous Succinate Tablets2220
8维生素B6注射液 · No verified English name2210
9Apalutamide Tablets2218
10Calcitriol Injection220

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

205 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Qi Ke Pharma Co., Ltd. romanized990
2Amgen Inc.930
3Eli Lilly and Company720
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
5Novo Nordisk A/S610
6Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized550
7Shenyang Dong Xin Pharma Co., Ltd. romanized540
8Sanofi Winthrop Industrie520
9Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized440
10Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized444

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

107 this week

AcceptedDrugApplicants
2025/03/29Generic · Class 3 Trimebutine Maleate TabletsCYHS2501232 Zhejiang Dong Ya Pharma Co., Ltd. romanized
2025/03/29Generic · Class 3 Trimebutine Maleate TabletsCYHS2501231 Zhejiang Dong Ya Pharma Co., Ltd. romanized
2025/03/29Generic · Class 3 厄贝沙坦氨氯地平片(III) · No verified English nameCYHS2501230 Zhejiang AngLiKang Pharmaceutical CO.,LTD.
2025/03/29Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2501229 Hunan Xian Shi Pharmaceutical Co., Ltd. romanized
2025/03/29Generic · Class 3 厄贝沙坦氨氯地平片(I) · No verified English nameCYHS2501228 Zhejiang AngLiKang Pharmaceutical CO.,LTD.
2025/03/29Generic · Class 3 Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2501227 Hainan Hai He Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/03/29Generic · Class 3 Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2501226 Hainan Hai He Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/03/29New drug · Class 2.2 AKZ002直服颗粒 · No verified English nameCXHL2500343 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2025/03/28Import · Class 3.1 度伐利尤单抗注射液 · No verified English nameJXSS2500038 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/03/28Import · Class 3.1 度伐利尤单抗注射液 · No verified English nameJXSS2500037 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/03/28Import · Class 1 Empasiprubart注射用浓溶液 · No verified English nameJXSL2500047 argenx BV; PPD Pharmaceutical Development(Beijing)Co.,Ltd.
2025/03/28Import · Class 1 PF-07985045片 · No verified English nameJXHL2500066 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/03/28Import · Class 1 PF-07985045片 · No verified English nameJXHL2500065 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2500064 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2500063 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2500062 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2500061 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2500060 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2500059 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Generic · Class 3 Epinastine Hydrochloride Eye DropsCYHS2501218 Can Tian Pharmaceutical (Zhongguo) Co., Ltd. romanized
2025/03/28Generic · Class 3 Famotidine InjectionCYHS2501216 Shanxi Ming Yu Bio Technology Co., Ltd. romanized; Gansu Cheng Ji Bio Pharma Co., Ltd. romanized
2025/03/28Generic · Class 3 Famotidine InjectionCYHS2501215 Shanxi Ming Yu Bio Technology Co., Ltd. romanized; Gansu Cheng Ji Bio Pharma Co., Ltd. romanized
2025/03/28Generic · Class 3 Dyclonine Topical SolutionCYHL2500073 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/03/28Generic · Class 3 溴莫尼定凝胶 · No verified English nameCYHL2500072 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/03/28New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2500026 Nan Tong Hui Ju Pharmaceutical Co., Ltd. romanized
2025/03/28New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2500025 Nan Tong Hui Ju Pharmaceutical Co., Ltd. romanized
2025/03/28New drug · Class 1 DZD6008片 · No verified English nameCXHL2500342 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Di Zhe (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/03/28New drug · Class 1 DZD6008片 · No verified English nameCXHL2500341 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Di Zhe (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/03/28New drug · Class 1 DZD6008片 · No verified English nameCXHL2500340 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Di Zhe (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/03/28New drug · Class 1 AOD113408注射液 · No verified English nameCXHL2500339 Chengdu Ao Da Bio Technology Co., Ltd. romanized

77 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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