YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 345 drug applications between 1 March 2025 and 7 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 57 drug names.

2025/03/01 – 2025/03/07

Period
2025/03/01 to 2025/03/07, 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
345
Drugs with new generic filings (by drug name, de-duplicated)
57
Accepted this week, now under review
8

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

345filings, 76 of them generic

By application type

Application typeFilings
Supplement183
Generic76
New drug53
Import re-registration14
Import13
Unspecified6

By drug type

Drug typeFilings
Chemical drug239
TCM56
Therapeutic biologic44
Prophylactic biologic5
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

57 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Polidocanol Injection5223
2Brexpiprazole Tablets3131
3Loxoprofen Sodium Oral Solution226
4Mupirocin Ointment2230
5Acetylcysteine Granules214
6Ibrutinib Tablets210
7Levetiracetam Tablets216
8Baricitinib Tablets2132
9Famotidine Injection218
10盐酸丙卡特罗吸入溶液 · No verified English name213

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

201 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized11110
2Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized990
3Bayer AG810
4Shanghai Min Wei Bio Technology Co., Ltd. romanized810
5Merck Sharp & Dohme B.V.750
6Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized550
7Pfizer Inc.530
8Novo Nordisk A/S510
9Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized510
10Guangdong Zhong Sheng Rui Chuang Bio Technology 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

101 this week

AcceptedDrugApplicants
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
2025/03/06Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSS2500022 Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.
2025/03/06Import · Class 1 PF-07275315注射液 · No verified English nameJXSL2500035 Pfizer Inc.; Pfizer Investment CO. Ltd.
2025/03/06Import · Class 1 BI 1291583 片 · No verified English nameJXHL2500035 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/03/06Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2500941 Hebei Tian Cheng Pharma Co., Ltd. romanized
2025/03/06Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2500940 Beijing SL Pharmaceutical Co., Ltd.
2025/03/06Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2500939 Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized
2025/03/06Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2500933 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2025/03/06Generic · Class 3 咪达唑仑鼻喷雾剂 · No verified English nameCYHL2500057 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2025/03/06Generic · Class 3 Irbesartan and Amlodipine TabletsCYHL2500056 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2025/03/06New drug · Class 1 注射用维贝柯妥塔单抗 · No verified English nameCXSS2500034 Le Pu Bio Technology Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanized
2025/03/06New drug · Class 1 IMM27M注射液 · No verified English nameCXSL2500204 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/03/06New drug · Class 1 TQB2930注射液 · No verified English nameCXSL2500203 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/03/06New drug · Class 1 TQB2930注射液 · No verified English nameCXSL2500202 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/03/06New drug · Class 1 CM336注射液 · No verified English nameCXSL2500201 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized

71 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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