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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 440 drug applications between 9 June 2025 and 15 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 122, covering 80 drug names.

2025/06/09 – 2025/06/15

Period
2025/06/09 to 2025/06/15, 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
440
Drugs with new generic filings (by drug name, de-duplicated)
80
Accepted this week, now under review
65

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

440filings, 122 of them generic

By application type

Application typeFilings
Supplement184
Generic122
New drug70
Import43
Unspecified11
Import re-registration9
Medical device (joint review)1

By drug type

Drug typeFilings
Chemical drug286
Therapeutic biologic73
TCM69
Biologic7
Prophylactic biologic3
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

80 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Injection181753
2Brexpiprazole Tablets4231
3苯磺酸左氨氯地平片 · No verified English name4245
4Carbidopa and Levodopa Sustained-release Tablets322
5Sacubitril Valsartan Sodium Tablets3270
6中性低钙腹膜透析液(碳酸氢盐-G4.25%) · No verified English name221
7Upadacitinib Sustained-release Tablets2243
8Ethyl Iosapentate Capsules2227
9Acetylcysteine Oral Solution2111
10Lactulose Oral Solution2134

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

271 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
5Qilu Pharmaceutical Co., Ltd.541
6Name not romanized530
7AstraZeneca AB520
8Pfizer Inc.520
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized520
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

145 this week

AcceptedDrugApplicants
2025/06/14Import · Class 1 注射用MK-2400 · No verified English nameJXSL2500089 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2025/06/14Import · Class 1 注射用MK-5909 · No verified English nameJXSL2500088 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2025/06/14Import · Class 2.4 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHL2500144 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd
2025/06/14Import · Class 2.4 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHL2500143 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd
2025/06/14Import · Class 1 AZD6793 · No verified English nameJXHL2500142 AstraZeneca AB
2025/06/14Import · Class 1 AZD6793 · No verified English nameJXHL2500141 AstraZeneca AB
2025/06/14Import · Class 1 AZD6793 · No verified English nameJXHL2500140 AstraZeneca AB
2025/06/14Generic · Class 3 Ketorolac Trometamol TabletsCYHS2502133 Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized
2025/06/14Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2502131 Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized
2025/06/14Generic · Class 3 Acetylcysteine Oral SolutionCYHS2502130 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2025/06/14Generic · Class 3 Acetylcysteine Oral SolutionCYHS2502129 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2025/06/14Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2502125 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/06/14Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2502123 Jiangsu Cheng Kang Pharma Co., Ltd. romanized
2025/06/14Generic · Class 3 醋酸锌颗粒 · No verified English nameCYHS2502120 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2025/06/14Generic · Class 3 醋酸锌颗粒 · No verified English nameCYHS2502119 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2025/06/14Generic · Class 3 贝美前列素涂剂 · No verified English nameCYHL2500113 Zhejiang Fu Nuo Pharmaceuticals Co., Ltd. romanized
2025/06/14New drug · Class 1 IBI343 · No verified English nameCXSL2500487 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/06/14New drug · Class 1 注射用ZG005 · No verified English nameCXSL2500486 Name not romanized; Name not romanized
2025/06/14New drug · Class 1 洛奈利单抗注射液 · No verified English nameCXSL2500485 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2025/06/14New drug · Class 2.2 兰索拉唑碳酸氢钠干混悬剂 · No verified English nameCXHS2500067 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/06/14New drug · Class 1 HP-001胶囊 · No verified English nameCXHL2500580 Shanghai Chao Yang Pharma Co., Ltd. romanized
2025/06/14New drug · Class 1 HP-001胶囊 · No verified English nameCXHL2500579 Shanghai Chao Yang Pharma Co., Ltd. romanized
2025/06/14New drug · Class 1 HP-001胶囊 · No verified English nameCXHL2500578 Shanghai Chao Yang Pharma Co., Ltd. romanized
2025/06/14New drug · Class 2.4 盐酸吉卡昔替尼片 · No verified English nameCXHL2500577 Name not romanized; Name not romanized
2025/06/14New drug · Class 1 注射用FZ-P001钠 · No verified English nameCXHL2500576 Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized
2025/06/14New drug · Class 2.2 JSS-222 · No verified English nameCXHL2500575 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/06/14New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2500574 Fujian Ji Nuo Hou Pu Bio Technology Co., Ltd. romanized
2025/06/14New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2500573 Fujian Ji Nuo Hou Pu Bio Technology Co., Ltd. romanized
2025/06/14New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2500572 Fujian Ji Nuo Hou Pu Bio Technology Co., Ltd. romanized
2025/06/14New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2500571 Fujian Ji Nuo Hou Pu Bio Technology Co., Ltd. romanized

115 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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