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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 380 drug applications between 26 January 2026 and 1 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 63, covering 47 drug names.

2026/01/26 – 2026/02/01

Period
2026/01/26 to 2026/02/01, 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
380
Drugs with new generic filings (by drug name, de-duplicated)
47
Accepted this week, now under review
91

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

380filings, 63 of them generic

By application type

Application typeFilings
Supplement225
Generic63
New drug63
Import16
Unspecified8
Import re-registration5

By drug type

Drug typeFilings
Chemical drug206
TCM105
Therapeutic biologic61
Prophylactic biologic5
Biologic2
In vitro diagnostic reagent1

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

47 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cefmetazole Sodium for Injection317
2莫立司他钠片 · No verified English name310
3褪黑素颗粒 · No verified English name2212
4Diclofenac Diethylamine Emulgel2120
5Perindopril tert-Butylamine Tablets215
6复方氨基酸注射液(17AA-Ⅲ) · No verified English name212
7左羟丙哌嗪口服溶液 · No verified English name218
8Empagliflozin Tablets2118
9Galantamine Hydrobromide Tablets212
10注射用头孢他啶/氯化钠注射液 · 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

217 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized14140
2Ha Yao Group Bio Gong Cheng Co., Ltd. romanized1470
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
4Shen Wei Pharma Group Co., Ltd. romanized660
5Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized660
6Novo Nordisk A/S610
7Pfizer Inc.440
8Dan Dong Pharma Group Co., Ltd. romanized440
9Jiangxi Wang Shi Pharma Co., Ltd. romanized440
10Sanofi Winthrop Industrie430

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

102 this week

AcceptedDrugApplicants
2026/01/31Import · Class 1 PF-08634404 · No verified English nameJXSL2600036 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/01/31Import · Class 1 PF-08046047 · No verified English nameJXSL2600035 Pfizer Inc.; Pfizer Investment CO. Ltd.
2026/01/31Import · Class 1 PF-08046054 (注射用冻干粉针) · No verified English nameJXSL2600034 Pfizer Inc.; Pfizer Investment CO. Ltd.
2026/01/31Import · Class 1 BMS-986504片 · No verified English nameJXHL2600031 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/01/31Generic · Class 3 Galantamine Hydrobromide TabletsCYHS2600329 Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized; Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized
2026/01/31Generic · Class 3 Galantamine Hydrobromide TabletsCYHS2600328 Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized; Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized
2026/01/31Generic · Class 3 Etoposide InjectionCYHS2600327 Wuxi Zi Shan Pharma Co., Ltd. romanized; Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2026/01/31Generic · Class 3 Doxycycline Hyclate for InjectionCYHS2600321 Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized
2026/01/31Generic · Class 3 Carbocisteine Oral SolutionCYHS2600320 Chengdu Giantech Hi-technology Development Co., Ltd.; Hunan Jiudian Pharmaceutical Co., Ltd
2026/01/31Generic · Class 3 Doxycycline Hyclate for InjectionCYHS2600319 Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized
2026/01/31Generic · Class 3 莫立司他钠片 · No verified English nameCYHL2600019 Shanghai Bo Zhi Yan Xin Drug Research Co., Ltd. romanized
2026/01/31Generic · Class 3 莫立司他钠片 · No verified English nameCYHL2600018 Shanghai Bo Zhi Yan Xin Drug Research Co., Ltd. romanized
2026/01/31Generic · Class 3 莫立司他钠片 · No verified English nameCYHL2600017 Shanghai Bo Zhi Yan Xin Drug Research Co., Ltd. romanized
2026/01/31New drug · Class 1.1 金柴胶囊 · No verified English nameCXZS2600010 Shen Wei Pharma Group Co., Ltd. romanized
2026/01/31New drug · Class 3.1 清金化痰颗粒 · No verified English nameCXZS2600009 Jiang Yin Tian Jiang Pharma Co., Ltd. romanized
2026/01/31New drug · Class 3.1 黄芪桂枝五物汤颗粒 · No verified English nameCXZS2600008 Shen Wei Pharma Group Co., Ltd. romanized
2026/01/31New drug · Class 1.1 地黄宝源颗粒 · No verified English nameCXZL2600020 Jing Yi He Sheng Pharmaceuticals (Guangdong Heng Qin Yue Ao Shen Du He Zuo Qu) Co., Ltd. romanized; Beijing Jing Yi He Sheng Pharmaceuticals Technology Co., Ltd. romanized
2026/01/31New drug · Class 1.1 地黄宝源颗粒 · No verified English nameCXZL2600019 Jing Yi He Sheng Pharmaceuticals (Guangdong Heng Qin Yue Ao Shen Du He Zuo Qu) Co., Ltd. romanized; Beijing Jing Yi He Sheng Pharmaceuticals Technology Co., Ltd. romanized
2026/01/31New drug · Class 1.1 茯苓运化颗粒 · No verified English nameCXZL2600018 Jing Yi He Sheng Pharmaceuticals (Guangdong Heng Qin Yue Ao Shen Du He Zuo Qu) Co., Ltd. romanized; Beijing Jing Yi He Sheng Pharmaceuticals Technology Co., Ltd. romanized
2026/01/31New drug · Class 1 GS3-007a干混悬剂 · No verified English nameCXHL2600135 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/01/30Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2600316 Henan Run Hong Pharmaceutical Co., Ltd. romanized
2026/01/30New drug · Class 3.1 清骨散颗粒 · No verified English nameCXZS2600007 Shen Wei Pharma Group Co., Ltd. romanized
2026/01/30New drug · Class 1 CMG2349注射液 · No verified English nameCXSL2600156 Chengdu En Mu Bio Technology Co., Ltd. romanized
2026/01/30New drug · Class 1 注射用MK-1045 · No verified English nameCXSL2600155 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2026/01/30New drug · Class 1 注射用MK-1045 · No verified English nameCXSL2600154 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2026/01/30New drug · Class 1 SG301注射液 · No verified English nameCXSL2600152 Hangzhou Shang Jian Bio Technology Co., Ltd. romanized
2026/01/30New drug · Class 1 SYS6051 · No verified English nameCXSL2600151 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/01/30New drug · Class 1 注射用LY4170156 · No verified English nameCXSL2600149 Li Lai Suzhou Pharmaceutical Co., Ltd. romanized
2026/01/30New drug · Class 2.4 注射用磷罗拉匹坦帕洛诺司琼 · No verified English nameCXHS2600019 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/01/30New drug · Class 2.4 氟[18F]妥司特注射液 · No verified English nameCXHL2600134 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized

72 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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