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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 357 drug applications between 3 March 2025 and 9 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 75 drug names.

2025/03/03 – 2025/03/09

Period
2025/03/03 to 2025/03/09, 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
357
Drugs with new generic filings (by drug name, de-duplicated)
75
Accepted this week, now under review
10

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

357filings, 97 of them generic

By application type

Application typeFilings
Supplement167
Generic97
New drug56
Import18
Import re-registration13
Unspecified6

By drug type

Drug typeFilings
Chemical drug269
Therapeutic biologic42
TCM40
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

75 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets5270
2Polidocanol Injection5223
3Brexpiprazole Tablets3131
4Ibuprofen Suspension2214
5洛索洛芬钠凝胶贴膏 · No verified English name229
6Loxoprofen Sodium Oral Solution226
7Acetylcysteine Granules214
8Levetiracetam Tablets216
9Baricitinib Tablets2132
10Famotidine Injection218

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

214 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized17170
2Bayer AG1130
3Shanghai Min Wei Bio Technology Co., Ltd. romanized810
4Merck Sharp & Dohme B.V.750
5Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized550
6Pfizer Inc.530
7Novo Nordisk A/S510
8Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized510
9Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized510
10Sichuan Pu Rui Te Pharma Co., Ltd. romanized421

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

105 this week

AcceptedDrugApplicants
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
2025/03/08New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2500213 Changchun Bai Ke Bio Technology Shareholding Company romanized
2025/03/08New drug · Class 1 注射用JS203 · No verified English nameCXSL2500212 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2025/03/08New drug · Class 1 DZD8586片 · No verified English nameCXHL2500261 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2025/03/08New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2500260 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/03/08New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2500259 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/03/08New drug · Class 2.1 KEM2403注射液 · No verified English nameCXHL2500258 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/03/07Generic · Class 3 Memantine Hydrochloride OD TabletsCYHS2500954 Hefei En Rui Te Pharma Co., Ltd. romanized
2025/03/07Generic · Class 3 Memantine Hydrochloride OD TabletsCYHS2500953 Hefei En Rui Te Pharma Co., Ltd. romanized
2025/03/07Generic · Class 3 Pyridostigmine Bromide TabletsCYHS2500951 Jilin Sheng Bo Da Wei Ye Pharmaceutical Co., Ltd. romanized
2025/03/07New drug · Class 1 SH006注射液 · No verified English nameCXSL2500211 Nanjing Sheng He Pharma Co., Ltd. romanized
2025/03/07New drug · Class 1 BPR-102胶囊 · No verified English nameCXSL2500210 Chengdu Bei Te Yi Kang En Biopharmaceuticals Technology Co., Ltd. romanized
2025/03/07New drug · Class 1 BPR-102胶囊 · No verified English nameCXSL2500209 Chengdu Bei Te Yi Kang En Biopharmaceuticals Technology Co., Ltd. romanized
2025/03/07New drug · Class 1.2 LVRNA015 · No verified English nameCXSL2500208 Zhuhai Li Fan Da Bio Technology Co., Ltd. romanized
2025/03/07New drug · Class 1 SHR-4712注射液 · No verified English nameCXSL2500207 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/03/07New drug · Class 1 SHR-4712注射液 · No verified English nameCXSL2500206 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/03/07New drug · Class 1 注射用CS2009 · No verified English nameCXSL2500205 Shen Shi Biopharmaceuticals (Shanghai) Co., Ltd. romanized; Ji Shi Pharma (Suzhou) Co., Ltd. romanized
2025/03/07New drug · Class 1 PRT-064040鼻喷雾剂 · No verified English nameCXHL2500257 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2025/03/07New drug · Class 1 PRT-064040鼻喷雾剂 · No verified English nameCXHL2500256 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2025/03/07New drug · Class 1 PRT-064040鼻喷雾剂 · No verified English nameCXHL2500255 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2025/03/07New drug · Class 1 TRD205片 · No verified English nameCXHL2500254 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2025/03/07New drug · Class 1 TRD205片 · No verified English nameCXHL2500253 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2025/03/07New drug · Class 2.2 KEM2418缓释直服颗粒 · No verified English nameCXHL2500252 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized

75 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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