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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 453 drug applications between 11 June 2025 and 17 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 125, covering 88 drug names.

2025/06/11 – 2025/06/17

Period
2025/06/11 to 2025/06/17, 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
453
Drugs with new generic filings (by drug name, de-duplicated)
88
Accepted this week, now under review
71

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

453filings, 125 of them generic

By application type

Application typeFilings
Supplement182
Generic125
New drug71
Import52
Unspecified12
Import re-registration10
Medical device (joint review)1

By drug type

Drug typeFilings
Chemical drug282
Therapeutic biologic85
TCM75
Biologic7
Prophylactic biologic2
In vitro diagnostic reagent1
Unspecified1

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

88 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Injection151553
2Brexpiprazole Tablets4231
3苯磺酸左氨氯地平片 · No verified English name4245
4Sacubitril Valsartan Sodium Tablets3270
5中性低钙腹膜透析液(碳酸氢盐-G4.25%) · No verified English name221
6Upadacitinib Sustained-release Tablets2243
7Acetylcysteine Oral Solution2111
8Lactulose Oral Solution2134
9Carbidopa and Levodopa Sustained-release Tablets212
10Perindopril tert-Butylamine Tablets215

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

273 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Merck Sharp & Dohme B.V.2210
2Henan Ying Feng Pharmaceuticals Co., Ltd. romanized880
3Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized770
4Rui Yang Pharmaceutical Co., Ltd. romanized720
5AstraZeneca AB630
6Amgen Inc.610
7Shijiazhuang No.4 Pharmaceutical Co., Ltd.554
8Name not romanized530
9Pfizer Inc.520
10Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized510

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

157 this week

AcceptedDrugApplicants
2025/06/17Import · Class 1 AMG 133 · No verified English nameJXSL2500096 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/17Import · Class 1 AMG 133 · No verified English nameJXSL2500095 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/17Import · Class 1 AMG 133 · No verified English nameJXSL2500094 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/17Import · Class 1 AMG 133 · No verified English nameJXSL2500093 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/17Import · Class 1 AMG 133 · No verified English nameJXSL2500092 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/17Import · Class 1 AMG 133 · No verified English nameJXSL2500091 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/17Import · Class 1 AZD6621 · No verified English nameJXSL2500090 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd
2025/06/17Import · Class 1 BI 907828片 · No verified English nameJXHL2500147 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/06/17Import · Class 1 BI 907828片 · No verified English nameJXHL2500146 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/06/17Import · Class 1 BI 907828片 · No verified English nameJXHL2500145 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/06/17Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2502162 Wuhan Yi Bo Yuan Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2025/06/17Generic · Class 3 Vincriscristine Sulfate InjectionCYHS2502160 Hainan Brilliant Pharmaceutical Co., Ltd.
2025/06/17Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2502158 Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized
2025/06/17Generic · Class 3 小儿复方氨基酸注射液(19AA-I) · No verified English nameCYHS2502157 Ran Dian (Nanjing) Biopharmaceuticals Technology Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2025/06/17Generic · Class 3 Gabapentin Oral SolutionCYHS2502156 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2025/06/17Generic · Class 3 Acetylcysteine TabletsCYHS2502155 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/06/17Generic · Class 3 盐酸精氨酸注射液 · No verified English nameCYHS2502154 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/06/17Generic · Class 3 Amisulpride Oral SolutionCYHS2502146 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2025/06/17Generic · Class 3 Ferrous Succinate TabletsCYHS2502145 Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized
2025/06/17Generic · Class 3 甲磺酸酚妥拉明滴眼液 · No verified English nameCYHL2500114 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized
2025/06/17New drug · Class 1.1 通窍静眩颗粒 · No verified English nameCXZL2500040 Jiu Hua Hua Yuan Pharma Co., Ltd. romanized
2025/06/17New drug · Class 3.3 德谷门冬双胰岛素注射液 · No verified English nameCXSS2500066 Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2025/06/17New drug · Class 3.3 德谷门冬双胰岛素注射液 · No verified English nameCXSS2500065 Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2025/06/17New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2500495 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/06/17New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2500494 Beijing Zai Sheng Bio Technology Research Institute Co., Ltd. romanized
2025/06/17New drug · Class 2.2 怡培生长激素注射液 · No verified English nameCXSL2500493 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2025/06/17New drug · Class 1 脐带间充质干细胞注射液 · No verified English nameCXSL2500492 Zhong Ke Ju Yan (Beijing) Bio Technology Co., Ltd. romanized
2025/06/17New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500491 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/06/17New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2500490 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2025/06/17New drug · Class 1 SY-005注射液 · No verified English nameCXSL2500489 Suzhou Ya Bao Drug Research and Development Co., Ltd. romanized

127 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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