YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 640 drug applications between 5 February 2026 and 11 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 63 drug names.

2026/02/05 – 2026/02/11

Period
2026/02/05 to 2026/02/11, 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
640
Drugs with new generic filings (by drug name, de-duplicated)
63
Accepted this week, now under review
149

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

640filings, 86 of them generic

By application type

Application typeFilings
Supplement401
New drug87
Generic86
Import33
Import re-registration17
Unspecified16

By drug type

Drug typeFilings
Chemical drug306
TCM237
Therapeutic biologic84
Biologic10
Prophylactic 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

63 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

273 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized123950
2Ha Yao Group Bio Gong Cheng Co., Ltd. romanized37190
3Jiangxi Pu Li Er Pharma Co., Ltd. romanized28270
4Jiangsu Hao Sen Pharma Group Co., Ltd. romanized1220
5Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized1080
6Guangzhou Wan Yi Te Medical Yong Pin Co., Ltd. romanized1060
7AstraZeneca AB950
8Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized880
9Janssen Research & Development LLC620
10Ai Min Pharma Group Co., Ltd. romanized550

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

152 this week

AcceptedDrugApplicants
2026/02/11Import · Class 1 Pegozafermin注射液 · No verified English nameJXSL2600052 89bio Inc.; Roche (China) Holding Ltd.
2026/02/11Import · Class 1 Pegozafermin注射液 · No verified English nameJXSL2600051 89bio Inc.; Roche (China) Holding Ltd.
2026/02/11Import · Class 1 Pegozafermin注射液 · No verified English nameJXSL2600050 89bio Inc.; Roche (China) Holding Ltd.
2026/02/11Import · Class 1 PF-08634404 · No verified English nameJXSL2600049 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/02/11Import · Class 1 PF-08634404 · No verified English nameJXSL2600048 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/02/11Import · Class 2.1 Nipocalimab注射液 · No verified English nameJXSL2600047 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/02/11Import · Class 2.1 Nipocalimab注射液 · No verified English nameJXSL2600046 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/02/11Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600045 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/02/11Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600044 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/02/11Import · Class 1 PF-08634404 · No verified English nameJXSL2600043 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/02/11Import · Class 1 PF-08634404 · No verified English nameJXSL2600042 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/02/11Import · Class 1 JDQ443片 · No verified English nameJXHL2600043 Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd
2026/02/11Import · Class 1 TAK-360片 · No verified English nameJXHL2600042 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2026/02/11Import · Class 1 TAK-360片 · No verified English nameJXHL2600041 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2026/02/11Import · Class 1 TAK-360片 · No verified English nameJXHL2600040 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2026/02/11Import · Class 1 TAK-360片 · No verified English nameJXHL2600039 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2026/02/11Import · Class 1 TAK-360片 · No verified English nameJXHL2600038 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2026/02/11Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2600450 Hainan Wan Wei Pharmaceutical Co., Ltd. romanized
2026/02/11Generic · Class 3 Cisplatin InjectionCYHS2600446 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2026/02/11Generic · Class 3 Cisplatin InjectionCYHS2600445 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2026/02/11Generic · Class 3 多种微量元素注射液(IV) · No verified English nameCYHS2600443 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2026/02/11Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2600442 Heng Yan Biopharmaceuticals Technology (Xiamen) Co., Ltd. romanized; Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized
2026/02/11Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2600441 Heng Yan Biopharmaceuticals Technology (Xiamen) Co., Ltd. romanized; Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized
2026/02/11Generic · Class 3 替普瑞酮颗粒 · No verified English nameCYHS2600440 Zhejiang He Li Xin Jian Pharma Co., Ltd. romanized
2026/02/11Generic · Class 3 盐酸羟甲唑啉滴鼻液 · No verified English nameCYHS2600439 Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized
2026/02/11Generic · Class 3 Nafamostat Mesilate for InjectionCYHL2600023 Name not romanized
2026/02/11New drug · Class 2.2 注射用瑞康曲妥珠单抗 · No verified English nameCXSS2600018 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Name not romanized
2026/02/11New drug · Class 1 HB0056注射液 · No verified English nameCXSL2600205 Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/02/11New drug · Class 1 XP-P01 · No verified English nameCXSL2600204 Shanghai Xin Pu Biopharmaceuticals Technology Co., Ltd. romanized
2026/02/11New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2600203 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized

122 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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