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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 360 drug applications between 15 April 2026 and 21 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 46 drug names.

2026/04/15 – 2026/04/21

Period
2026/04/15 to 2026/04/21, 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
360
Drugs with new generic filings (by drug name, de-duplicated)
46
Accepted this week, now under review
94

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

360filings, 57 of them generic

By application type

Application typeFilings
Supplement199
New drug65
Generic57
Import16
Unspecified12
Import re-registration11

By drug type

Drug typeFilings
Chemical drug170
TCM127
Therapeutic biologic52
Biologic10
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

46 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1注射用磷酸左奥硝唑酯二钠 · No verified English name2222
2头孢丙烯干混悬剂 · No verified English name212
3Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2123
4Imipenem and Cilastatin Sodium for Injection216
5Urapidil Hydrochloride Injection216
6盐酸氢吗啡酮片 · No verified English name210
7Azilsartan Medoxomil Potassium Tablets2135
8Amlodipine Besylate Tablets218
9Sitagliptin and Metformin Hydrochloride Extended-release Tablets2112
10Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ)215

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

236 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Janssen-Cilag International NV730
2Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
3Xinjiang Wei Wu Er Pharma Co., Ltd. romanized630
4Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized550
5Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized510
6Zhong Shan Shi Heng Sheng Pharma Co., Ltd. romanized440
7Fuzhou Min Hai Pharma Co., Ltd. romanized440
8Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized440
9Xian Bo Ai Pharmaceutical Co., Ltd. romanized440
10Yunnan Bai Yao Group Co., Ltd. romanized430

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

99 this week

AcceptedDrugApplicants
2026/04/21Import · Class 2.4 Upadacitinib Sustained-release TabletsJXHS2600042 AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V.
2026/04/21Import · Class 2.4 LOU064片 · No verified English nameJXHL2600117 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/04/21Generic · Class 3 Ketoprofen PatchesCYHS2600915 Beijing Foyou Pharma CO.,LTD; Fu Yuan Pharma Co., Ltd. romanized
2026/04/21Generic · Class 3 Ketoprofen PatchesCYHS2600914 Beijing Foyou Pharma CO.,LTD; Fu Yuan Pharma Co., Ltd. romanized
2026/04/21Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2600911 San Jin Group Hunan San Jin Pharmaceutical Co., Ltd. romanized
2026/04/21Generic · Class 3 Progesterone InjectionCYHS2600910 Hunan Xian Shi Pharmaceutical Co., Ltd. romanized
2026/04/21Generic · Class 3 Ebastine Oral SolutionCYHS2600909 Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2026/04/21Generic · Class 3 盐酸氢吗啡酮片 · No verified English nameCYHL2600055 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/04/21Generic · Class 3 盐酸氢吗啡酮片 · No verified English nameCYHL2600054 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/04/21New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2600428 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/04/21New drug · Class 1 HMBD-001 · No verified English nameCXSL2600427 Shanghai He Wei Si Te Pharmaceuticals Technology Co., Ltd. romanized
2026/04/21New drug · Class 2.2 HY-1016缓释注射液 · No verified English nameCXHL2600469 Name not romanized
2026/04/21New drug · Class 2.2 HY-1016缓释注射液 · No verified English nameCXHL2600468 Name not romanized
2026/04/21New drug · Class 2.2 HY-1016缓释注射液 · No verified English nameCXHL2600467 Name not romanized
2026/04/21New drug · Class 2.2 HY-1016缓释注射液 · No verified English nameCXHL2600466 Name not romanized
2026/04/20New drug · Class 1 CMS-F021凝胶 · No verified English nameCXHL2600472 Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized
2026/04/20New drug · Class 1 CMS-F021凝胶 · No verified English nameCXHL2600471 Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized
2026/04/20New drug · Class 1 CMS-F021凝胶 · No verified English nameCXHL2600470 Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized
2026/04/20New drug · Class 1 BG-75202片 · No verified English nameCXHL2600465 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/04/20New drug · Class 1 BG-75202片 · No verified English nameCXHL2600464 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/04/20New drug · Class 1 BG-75202片 · No verified English nameCXHL2600463 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/04/18Generic · Class 3 Methocarbamol InjectionCYHS2600895 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/04/18Generic · Class 3 头孢丙烯干混悬剂 · No verified English nameCYHS2600894 Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2026/04/18Generic · Class 3 头孢丙烯干混悬剂 · No verified English nameCYHS2600893 Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2026/04/18Generic · Class 3 Fudosteine oral solutionCYHS2600892 Jiangsu Chen Pai Bang De Pharma Co., Ltd. romanized
2026/04/18New drug · Class 2.2 HKGM-452 · No verified English nameCXHL2600462 Tianjin Han Rui Pharma Co., Ltd. romanized
2026/04/18New drug · Class 1 TT-01488片 · No verified English nameCXHL2600461 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2026/04/18New drug · Class 1 PP011胶囊 · No verified English nameCXHL2600460 Pei Tai (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2026/04/17Import · Class 2.2 特立妥单抗注射液 · No verified English nameJXSS2600039 Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.
2026/04/17Import · Class 2.2 特立妥单抗注射液 · No verified English nameJXSS2600038 Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.

69 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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