YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 325 drug applications between 5 March 2025 and 11 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 70 drug names.

2025/03/05 – 2025/03/11

Period
2025/03/05 to 2025/03/11, 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
325
Drugs with new generic filings (by drug name, de-duplicated)
70
Accepted this week, now under review
9

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

325filings, 97 of them generic

By application type

Application typeFilings
Supplement140
Generic97
New drug49
Import18
Import re-registration12
Unspecified9

By drug type

Drug typeFilings
Chemical drug252
Therapeutic biologic36
TCM31
Prophylactic biologic6

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

70 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Brexpiprazole Tablets5231
2Sacubitril Valsartan Sodium Tablets5270
3Polidocanol Injection5223
4Bisoprolol Fumarate and Amlodipine Besylate Tablets229
5洛索洛芬钠凝胶贴膏 · No verified English name229
6Loxoprofen Sodium Oral Solution226
7Glucosamine Sulfate Capsules2251
8Acipimox Capsules222
9Multiple Vitamins Injection214
10Levetiracetam Tablets216

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

197 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized17170
2Fresenius Kabi Deutschland GmbH910
3Bayer AG630
4Novo Nordisk A/S510
5Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized510
6Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized510
7Qilu Pharmaceutical Co., Ltd.430
8Sichuan Pu Rui Te Pharma Co., Ltd. romanized421
9Bayer Vital GmbH410
10CHEPLAPHARM Schweiz GmbH410

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

90 this week

AcceptedDrugApplicants
2025/03/11Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2500036 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2025/03/11Generic · Class 3 Multiple Vitamins InjectionCYHS2501006 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2025/03/11Generic · Class 3 Multiple Vitamins InjectionCYHS2501005 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2025/03/11Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2501002 Guangdong Sunho Pharmaceutical Co., Ltd.
2025/03/11Generic · Class 3 甲氧氯普胺片 · No verified English nameCYHS2500997 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2025/03/11Generic · Class 3 甲氧氯普胺片 · No verified English nameCYHS2500996 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2025/03/11New drug · Class 2.1; 2.2 泰它西普注射液 · No verified English nameCXSL2500219 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2025/03/11New drug · Class 2.2 帕尼单抗注射液 · No verified English nameCXSL2500218 Qilu Pharmaceutical Co., Ltd.
2025/03/11New drug · Class 2.2 QL2107注射液 · No verified English nameCXSL2500217 Qilu Pharmaceutical Co., Ltd.
2025/03/11New drug · Class 2.2 注射用MK-2870 · No verified English nameCXSL2500216 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2025/03/11New drug · Class 1 RGT-274-CR胶囊 · No verified English nameCXHL2500268 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2025/03/11New drug · Class 1 RGT-274-CR胶囊 · No verified English nameCXHL2500267 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2025/03/11New drug · Class 1 RGT-274-CR胶囊 · No verified English nameCXHL2500266 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2025/03/11New drug · Class 1 GCJ490-A片 · No verified English nameCXHL2500265 Yan Tai Drug Research Institute romanized; Yan Tai Xin Yao Chuang Zhi Shandong Sheng Laboratory romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized
2025/03/11New drug · Class 1 GCJ490-A片 · No verified English nameCXHL2500264 Yan Tai Drug Research Institute romanized; Yan Tai Xin Yao Chuang Zhi Shandong Sheng Laboratory romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized
2025/03/11New drug · Class 1 QLC1101胶囊 · No verified English nameCXHL2500263 Qilu Pharmaceutical Co., Ltd.
2025/03/11New drug · Class 1 QLC1101胶囊 · No verified English nameCXHL2500262 Qilu Pharmaceutical Co., Ltd.
2025/03/10Import · Class 2.4 钇[90Y]微球注射液 · No verified English nameJXHL2500037 Sirtex Medical Pty Ltd
2025/03/10Generic · Class 3 Sucralfate Oral SuspensionCYHS2500989 Anhui Rui Qi Pharma Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2025/03/10Generic · Class 3 Aminophylline TabletsCYHS2500988 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized
2025/03/10Generic · Class 3 奥泽沙星洗剂 · No verified English nameCYHL2500058 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2025/03/10New drug · Class 1 XH001注射液 · No verified English nameCXSL2500215 Beijing Xin He Rui En Bio Medical Technology Co., Ltd. romanized
2025/03/09New drug · Class 1 JMT106注射液 · No verified English nameCXSL2500214 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2025/03/08Import · Class 1 BMS-986365胶囊 · No verified English nameJXHL2500036 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/03/08Generic · Class 3 Buspirone Hydrochloride TabletsCYHS2500983 Hebei Long Hai Pharma Co., Ltd. romanized
2025/03/08Generic · Class 3 盐酸多沙普仑注射液 · No verified English nameCYHS2500976 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2025/03/08Generic · Class 3 Propafenone Hydrochloride InjectionCYHS2500968 Nan Yang Pu Kang Heng Wang Pharma Co., Ltd. romanized; Nan Yang Pu Kang Pharma Co., Ltd. romanized
2025/03/08Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2500967 Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2025/03/08Generic · Class 3 维生素K滴剂 · No verified English nameCYHS2500965 Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Tianjin Shi Zhong Yang Pharma Co., Ltd. romanized
2025/03/08Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2500964 Wuhan Shi Jin Heng Tai Pharma Co., Ltd. romanized; Henan Pu Rui Pharma Co., Ltd. romanized

60 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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