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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 436 drug applications between 22 February 2026 and 28 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 104, covering 78 drug names.

2026/02/22 – 2026/02/28

Period
2026/02/22 to 2026/02/28, 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
436
Drugs with new generic filings (by drug name, de-duplicated)
78
Accepted this week, now under review
160

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

436filings, 104 of them generic

By application type

Application typeFilings
Supplement183
New drug105
Generic104
Import25
Unspecified15
Import re-registration4

By drug type

Drug typeFilings
Chemical drug285
Therapeutic biologic89
TCM53
Prophylactic biologic6
Biologic3

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

78 drugs with new generic filings; top 10 listed

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

256 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized750
2Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized740
3Novartis Pharma AG730
4The Wellcome Foundation Limited720
5Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized660
6Takeda Development Center Americas Inc.620
7Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized620
8Luo Yang Shun Shi Pharma Co., Ltd. romanized550
9Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized540
10Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized545

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

171 this week

AcceptedDrugApplicants
2026/02/28Import · Class 1 JNJ-88549968注射液 · No verified English nameJXSL2600059 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/02/28Import · Class 2.2 伊奈利珠单抗注射液 · No verified English nameJXSL2600058 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/02/28Generic · Class 3 Milnacipran Hydrochloride TabletsCYHS2600586 Zhejiang Hua Bei Pharma Co., Ltd. romanized; Le Pu Pharmaceutical Technology Co., Ltd. romanized
2026/02/28Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2600584 Beijing Sheng Yong Pharmaceutical Co., Ltd. romanized
2026/02/28Generic · Class 3 Potassium Aspartate InjectionCYHS2600583 Zhejiang Hai Han Pharma Co., Ltd. romanized
2026/02/28Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2600581 Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Zhong Tong Pharma Co., Ltd. romanized
2026/02/28Generic · Class 3 聚乙二醇钠钾散 · No verified English nameCYHS2600579 Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Hangzhou Qian Yuan Bao Ling Pharma Co., Ltd. romanized
2026/02/28Generic · Class 3 Mexiletine Hydrochloride TabletsCYHS2600575 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized
2026/02/28Generic · Class 3 Fluocinolone Acetonide,Hydroquinone And Tretinoin CreamCYHL2600032 Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized
2026/02/28New drug · Class 2.3 蒲元和胃胶囊 · No verified English nameCXZL2600024 Qingdao Hua Ren Tai Pharmaceuticals Ye Co., Ltd. romanized
2026/02/28New drug · Class 1 CRPA1A2注射液 · No verified English nameCXSL2600286 Beijing Ke Rui Bio Technology Co., Ltd. romanized
2026/02/28New drug · Class 1 注射用HS-20108 · No verified English nameCXSL2600280 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/02/28New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2600279 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/02/28New drug · Class 1 SHR-7787注射液 · No verified English nameCXSL2600278 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/02/28New drug · Class 1 SHR-7787注射液 · No verified English nameCXSL2600277 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/02/28New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2600276 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/02/28New drug · Class 1 注射用重组巴曲酶 · No verified English nameCXSL2600275 Beijing Ge Rui Te Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/02/28New drug · Class 2.2 QL2107注射液 · No verified English nameCXSL2600273 Qilu Pharmaceutical Co., Ltd.
2026/02/28New drug · Class 2.2 西妥昔单抗β注射液 · No verified English nameCXSL2600272 Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized
2026/02/28New drug · Class 1 SI-B036双特异性抗体注射液 · No verified English nameCXSL2600271 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/02/28New drug · Class 1 DB006溶瘤腺病毒注射液 · No verified English nameCXSL2600270 Hainan Ji Min Bo Ao International Hospital Co., Ltd. romanized; Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized
2026/02/28New drug · Class 1 注射用MRG001 · No verified English nameCXSL2600269 Le Pu Bio Technology Co., Ltd. romanized
2026/02/28New drug · Class 1 注射用HDM2017 · No verified English nameCXSL2600268 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2026/02/28New drug · Class 2.3 多替拉韦拉米夫定替诺福韦片 · No verified English nameCXHS2600037 Shanghai Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized
2026/02/28New drug · Class 2.2 BR170720口服混悬液 · No verified English nameCXHS2600036 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2026/02/28New drug · Class 2.4 妥拉美替尼胶囊 · No verified English nameCXHL2600245 Shanghai Ke Zhou Drug Co., Ltd. romanized
2026/02/28New drug · Class 2.4 妥拉美替尼胶囊 · No verified English nameCXHL2600244 Shanghai Ke Zhou Drug Co., Ltd. romanized
2026/02/27Import · Class 1 ECI830 · No verified English nameJXHL2600071 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/02/27Import · Class 1 ECI830 · No verified English nameJXHL2600070 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/02/27Import · Class 1 ECI830 · No verified English nameJXHL2600069 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.

141 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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