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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 306 drug applications between 24 May 2025 and 30 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 57 drug names.

2025/05/24 – 2025/05/30

Period
2025/05/24 to 2025/05/30, 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
306
Drugs with new generic filings (by drug name, de-duplicated)
57
Accepted this week, now under review
33

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

306filings, 76 of them generic

By application type

Application typeFilings
Supplement151
Generic76
New drug50
Import14
Unspecified8
Import re-registration6
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug196
TCM54
Therapeutic biologic45
Prophylactic biologic7
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

57 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Injection4453
2Dapagliflozin Tablets4284
3Adapalene And Benzoyl Peroxide Gel3230
4Brexpiprazole Tablets3131
5Glucosamine Sulfate Capsules2251
6维生素B6注射液 · No verified English name2210
7利伐沙班口崩片 · No verified English name214
8复方氨基酸注射液(20AA-Ⅱ) · No verified English name210
9Levothyroxine Sodium Tablets2112
10Levobupivacaine Hydrochloride Injection212

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

193 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shaanxi Pan Long Pharma Group Co., Ltd. romanized13110
2Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized730
3Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized610
4Haerbin Tong Yi Tang Pharma Co., Ltd. romanized440
5Quan Zhou Zhong Qiao Pharma Co., Ltd. romanized440
6Guizhou Sheng Shi Long Fang Pharmaceutical Co., Ltd. romanized440
7UCB Pharma S.A.410
8Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized410
9Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized410
10Jilin Sheng Qi Ke Pharma Co., Ltd. romanized330

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

82 this week

AcceptedDrugApplicants
2025/05/30Import · Class 2.2 伊奈利珠单抗注射液 · No verified English nameJXSS2500070 Horizon Therapeutics Ireland DAC; AstraZeneca Nijmegen B.V.; Changzhou Hansoh Pharmaceutical Co. Ltd.
2025/05/30Import · Class 1 PF-08046047 · No verified English nameJXSL2500085 Pfizer Inc.; Pfizer Investment CO. Ltd.
2025/05/30Import · Class 2.1 Mosunetuzumab Injection (Subcutaneous Injection) · No verified English nameJXSL2500084 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2025/05/30Import · Class 2.1 Mosunetuzumab Injection (Subcutaneous Injection) · No verified English nameJXSL2500083 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2025/05/30Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2501936 Shanghai He Feng Pharmaceutical Co., Ltd. romanized
2025/05/30Generic · Class 3 复方氨基酸注射液(20AA-Ⅱ) · No verified English nameCYHS2501930 Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2025/05/30Generic · Class 3 复方氨基酸注射液(20AA-Ⅱ) · No verified English nameCYHS2501929 Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2025/05/30Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2501927 Nanjing Hai Jing Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2025/05/30Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2501926 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/05/30Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2501925 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/05/30New drug · Class 3.3 雷珠单抗注射液 · No verified English nameCXSS2500055 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2025/05/30New drug · Class 1 注射用YL202 · No verified English nameCXSL2500437 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2025/05/30New drug · Class 1 BGB-16673片 · No verified English nameCXHL2500526 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/05/30New drug · Class 1 BGB-16673片 · No verified English nameCXHL2500525 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/05/30New drug · Class 1 SZ2001片 · No verified English nameCXHL2500524 Su Zhong Pharma Group Co., Ltd. romanized; Jiangsu Su Zhong Pharma Research Institute Co., Ltd. romanized
2025/05/30New drug · Class 1 SZ2001片 · No verified English nameCXHL2500523 Su Zhong Pharma Group Co., Ltd. romanized; Jiangsu Su Zhong Pharma Research Institute Co., Ltd. romanized
2025/05/30New drug · Class 1 HSK47388片 · No verified English nameCXHL2500522 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2025/05/30New drug · Class 1 HSK47388片 · No verified English nameCXHL2500521 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2025/05/30New drug · Class 2.2 CZ006注射液 · No verified English nameCXHL2500520 Zhejiang Cui Ze Pharmaceuticals Technology Co., Ltd. romanized
2025/05/29Import · Class 1 Giredestrant · No verified English nameJXHL2500122 Genentech Inc.; Roche (China) Holding Ltd.
2025/05/29Generic · Class 3 Ketotifen Fumarate Oral SolutionCYHS2501921 Anhui Mao Kang Pharma Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2025/05/29Generic · Class 3 中性腹膜透析液(碳酸氢盐-G4.25%) · No verified English nameCYHS2501913 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/05/29Generic · Class 3 Deoxycholic Acid InjectionCYHL2500099 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/05/29New drug · Class 1.2 JMZ-2102胶囊 · No verified English nameCXZL2500034 Jiangxi Ji Min Ke Xin Pharma Co., Ltd. romanized
2025/05/29New drug · Class 1.2 JMZ-2102 · No verified English nameCXZL2500033 Jiangxi Ji Min Ke Xin Pharma Co., Ltd. romanized
2025/05/29New drug · Class 1.1 健脾疏肝固本颗粒 · No verified English nameCXZL2500032 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2025/05/29New drug · Class 1 注射用YL201 · No verified English nameCXSL2500436 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2025/05/29New drug · Class 1 IBI363 · No verified English nameCXSL2500435 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/05/29New drug · Class 1 IBI363 · No verified English nameCXSL2500434 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/05/29New drug · Class 1 注射用MHB088C · No verified English nameCXSL2500433 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized

52 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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