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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 323 drug applications between 1 April 2025 and 7 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 59 drug names.

2025/04/01 – 2025/04/07

Period
2025/04/01 to 2025/04/07, 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
323
Drugs with new generic filings (by drug name, de-duplicated)
59
Accepted this week, now under review
22

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

323filings, 82 of them generic

By application type

Application typeFilings
Supplement172
Generic82
New drug42
Import17
Unspecified6
Import re-registration4

By drug type

Drug typeFilings
Chemical drug178
TCM93
Therapeutic biologic51
Prophylactic 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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Brexpiprazole Tablets4231
2Tadalafil Tablets3123
3维生素B6注射液 · No verified English name2210
4低钙腹膜透析液(乳酸盐-G1.5%) · No verified English name213
5低钙腹膜透析液(乳酸盐-G2.5%) · No verified English name214
6低钙腹膜透析液(乳酸盐-G4.25%) · No verified English name213
7Dexketoprofen Trometamol Tablets210
8Tropicamide Phenylephrine Eye Drops218
9Fusidic Acid Cream2115
10Empagliflozin Tablets2118

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

175 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shaanxi Pan Long Pharma Group Co., Ltd. romanized13110
2Ningbo Tian Yi Pharma Technology Co., Ltd. romanized12612
3Guo Yao Group Beijing Hua Miao Pharma Co., Ltd. romanized11100
4Shenyang Dong Xin Pharma Co., Ltd. romanized1060
5Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized860
6Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized660
7Bayer Inc.610
8Shandong Er Ye Pharmaceutical Co., Ltd. romanized540
9Merck Healthcare KGaA530
10Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized520

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

79 this week

AcceptedDrugApplicants
2025/04/07Import · Class 2.4 英克司兰钠注射液 · No verified English nameJXHS2500043 Novartis Europharm Limited; Novartis Pharmaceutical Manufacturing GmbH; Beijing Novartis Pharma Co. Ltd.
2025/04/07Import · Class 1 Lartesertib片剂 · No verified English nameJXHL2500071 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2025/04/07Import · Class 1 Tuvusertib片剂 · No verified English nameJXHL2500070 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2025/04/07Import · Class 1 Tuvusertib片剂 · No verified English nameJXHL2500069 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2025/04/07Import · Class 1 Tuvusertib胶囊 · No verified English nameJXHL2500068 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2025/04/07Import · Class 1 Tuvusertib胶囊 · No verified English nameJXHL2500067 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2025/04/07Generic · Class 3 Acyclovir Sodium InjectionCYHS2501313 Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Henan Pu Rui Pharma Co., Ltd. romanized
2025/04/07Generic · Class 3 Acyclovir Sodium InjectionCYHS2501312 Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Henan Pu Rui Pharma Co., Ltd. romanized
2025/04/07Generic · Class 3 维生素K滴剂 · No verified English nameCYHS2501309 Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Da Lian Mei Chuang Pharma Co., Ltd. romanized
2025/04/07New drug · Class 3.1 开心散 · No verified English nameCXZS2500015 Anhui Hua Run Jin Chan Pharma Co., Ltd. romanized
2025/04/07New drug · Class 1 CM512注射液 · No verified English nameCXSL2500275 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2025/04/07New drug · Class 2.2 塔戈利单抗注射液 · No verified English nameCXSL2500271 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2025/04/07New drug · Class 1 注射用SKB315 · No verified English nameCXSL2500270 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2025/04/07New drug · Class 1 注射用SSGJ-612 · No verified English nameCXSL2500269 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/04/07New drug · Class 1 SSGJ-707注射液 · No verified English nameCXSL2500268 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/04/07New drug · Class 1 重组抗IL-1β人源化单克隆抗体注射液 · No verified English nameCXSL2500267 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2025/04/07New drug · Class 1 注射用TQB6411 · No verified English nameCXSL2500266 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/04/07New drug · Class 1 68Ga-NRT6020注射液 · No verified English nameCXHL2500358 Chengdu Niu Rui Te Medical Technology Co., Ltd. romanized
2025/04/07New drug · Class 2.1; 2.2 JMHT05 · No verified English nameCXHL2500357 Hunan Jiudian Pharmaceutical Co., Ltd
2025/04/07New drug · Class 2.1; 2.2 JMHT05 · No verified English nameCXHL2500356 Hunan Jiudian Pharmaceutical Co., Ltd
2025/04/03Import · Class 3.1 注射用德曲妥珠单抗 · No verified English nameJXSS2500041 Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2025/04/03Import · Class 3.1 本瑞利珠单抗注射液 · No verified English nameJXSS2500040 AstraZeneca AB; Name not romanized
2025/04/03Import · Class 3.1 本瑞利珠单抗注射液 · No verified English nameJXSS2500039 AstraZeneca AB; Name not romanized
2025/04/03Import · Class 2.2 Ravulizumab注射液 · No verified English nameJXSL2500052 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2025/04/03Import · Class 2.2 Ravulizumab注射液 · No verified English nameJXSL2500051 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2025/04/03Import · Class 1 Bimagrumab注射液 · No verified English nameJXSL2500050 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/03Import · Class 1 Bimagrumab注射液 · No verified English nameJXSL2500049 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/03Import · Class 2.2 注射用佐妥昔单抗 · No verified English nameJXSL2500048 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2025/04/03Generic · Class 3 Diprophylline InjectionCYHS2501299 Shandong Yi Jian Pharma Co., Ltd. romanized
2025/04/03Generic · Class 3 Acetylcysteine TabletsCYHS2501292 Hainan Sai Li Ke Pharma Co., Ltd. romanized

49 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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