YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 558 drug applications between 6 February 2026 and 12 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 58 drug names.

2026/02/06 – 2026/02/12

Period
2026/02/06 to 2026/02/12, 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
558
Drugs with new generic filings (by drug name, de-duplicated)
58
Accepted this week, now under review
137

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

558filings, 76 of them generic

By application type

Application typeFilings
Supplement345
New drug79
Generic76
Import33
Import re-registration14
Unspecified11

By drug type

Drug typeFilings
Chemical drug286
TCM172
Therapeutic biologic89
Biologic8
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

58 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. romanized63490
2Ha Yao Group Bio Gong Cheng Co., Ltd. romanized37190
3Jiangxi Pu Li Er Pharma Co., Ltd. romanized28270
4Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized1080
5Guangzhou Wan Yi Te Medical Yong Pin Co., Ltd. romanized1060
6Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized660
7Janssen Research & Development LLC620
8Pfizer Inc.620
9Jiangsu Hao Sen Pharma Group Co., Ltd. romanized610
10AstraZeneca AB530

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

138 this week

AcceptedDrugApplicants
2026/02/12Generic · Class 3 Deferasirox TabletsCYHS2600454 Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized
2026/02/12New drug · Class 1 SHR-1918注射液 · No verified English nameCXSS2600019 Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized; Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/02/12New drug · Class 1 注射用ZL-6201 · No verified English nameCXSL2600217 Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/02/12New drug · Class 1 人前脑神经前体细胞注射液 · No verified English nameCXSL2600214 Shanghai Huo Jian De Biopharmaceuticals Co., Ltd. romanized; Zhejiang Huo De Bio Gong Cheng Co., Ltd. romanized
2026/02/12New drug · Class 1 人前脑神经前体细胞注射液 · No verified English nameCXSL2600212 Shanghai Huo Jian De Biopharmaceuticals Co., Ltd. romanized; Zhejiang Huo De Bio Gong Cheng Co., Ltd. romanized
2026/02/12New drug · Class 1 注射用SKB565 · No verified English nameCXSL2600209 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/02/12New drug · Class 2.1; 2.2 泰它西普注射液 · No verified English nameCXSL2600208 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2026/02/12New drug · Class 1 注射用SIBP-A19 · No verified English nameCXSL2600207 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2026/02/12New drug · Class 1 SHR-7590注射液 · No verified English nameCXSL2600206 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/02/12New drug · Class 1 BDHK-2009片 · No verified English nameCXHL2600184 Bo Di He Kang (Shao Xing) Bio Technology Co., Ltd. romanized
2026/02/12New drug · Class 1 BDHK-2009片 · No verified English nameCXHL2600183 Bo Di He Kang (Shao Xing) Bio Technology Co., Ltd. romanized
2026/02/12New drug · Class 1 TM471-1胶囊 · No verified English nameCXHL2600182 Zhi Wei Pharma Technology (Shanghai) Co., Ltd. romanized
2026/02/12New drug · Class 1 TM471-1胶囊 · No verified English nameCXHL2600181 Zhi Wei Pharma Technology (Shanghai) Co., Ltd. romanized
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

108 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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