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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 389 drug applications between 27 March 2026 and 2 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 36 drug names.

2026/03/27 – 2026/04/02

Period
2026/03/27 to 2026/04/02, 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
389
Drugs with new generic filings (by drug name, de-duplicated)
36
Accepted this week, now under review
101

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

389filings, 48 of them generic

By application type

Application typeFilings
Supplement240
New drug59
Generic48
Import18
Unspecified12
Import re-registration12

By drug type

Drug typeFilings
Chemical drug195
TCM138
Therapeutic biologic52
Biologic2
Prophylactic biologic2

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

36 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Mirogabalin Besilate Tablets3261
2Oxycodone Hydrochloride and Naloxone Hydrochloride Prolonged-release Tablets313
3Tacrolimus Sustained-release Capsules216
4Linagliptin and Metformin Hydrochloride Extended Release Tablets214
5Diclofenac Diethylamine Emulgel2120
6Cefditoren Pivoxil Granules2118
7Montelukast Sodium Chewable Tablets214
8Epinastine Hydrochloride Tablets212
9Labetalol Hydrochloride Tablets213
10褪黑素颗粒 · No verified English name2112

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

227 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Dong E E Jiao Co., Ltd. romanized1190
2Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized1010
3Zhejiang Guo Jing Pharma Co., Ltd. romanized920
4Jiangsu Ke Lun Pharma Co., Ltd. romanized810
5Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized660
6Henan Nuo Mei Pharma Co., Ltd. romanized550
7AstraZeneca AB540
8Ha Yao Group Bio Gong Cheng Co., Ltd. romanized520
9Takeda Development Center Americas Inc.510
10Jiangsu Fei Sen You Si Pharmaceuticals Yong Pin Co., Ltd. romanized440

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

86 this week

AcceptedDrugApplicants
2026/04/02Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600027 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S. p. A.; MSD R&D (China) Co. Ltd
2026/04/02Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600026 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/04/02Import · Class 2.2 奥妥珠单抗注射液 · No verified English nameJXSS2600025 Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH; Roche (China) Holding Ltd.
2026/04/02Import · Class 2.2 注射用德曲妥珠单抗 · No verified English nameJXSS2600024 Daiichi Sankyo Europe GmbH; Simtra Deutschland GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2026/04/02Import · Class 1 PF-08634404 · No verified English nameJXSL2600089 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/04/02Import · Class 1 AZD8965片 · No verified English nameJXHL2600098 AstraZeneca AB; Name not romanized
2026/04/02Import · Class 1 AZD8965片 · No verified English nameJXHL2600097 AstraZeneca AB; Name not romanized
2026/04/02Import · Class 2.4 硫酸瑞美吉泮口崩片 · No verified English nameJXHL2600096 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd
2026/04/02New drug · Class 1 普那利单抗注射液 · No verified English nameCXSL2600373 Tian Jing Bio Pharma (Hangzhou) Co., Ltd. romanized
2026/04/02New drug · Class 1 注射用Efimosfermin alfa · No verified English nameCXSL2600372 Ge Lan Su Shi Ke (Zhongguo) Investment Co., Ltd. romanized
2026/04/02New drug · Class 1 注射用GenSci136 · No verified English nameCXSL2600371 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/04/02New drug · Class 1 CB03-154片 · No verified English nameCXHL2600403 Shanghai Zhi Meng Pharmaceuticals Technology Co., Ltd. romanized
2026/04/01Import · Class 2.2 Depemokimab注射液 · No verified English nameJXSL2600088 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2026/04/01Import · Class 1 ASP3082注射液 · No verified English nameJXHL2600095 Astellas Pharma Global Development Inc.; Astellas (Beijing) Pharmaceutical R&D Co. Ltd.
2026/04/01Generic · Class 3 镥[177Lu]氧奥曲肽注射液 · No verified English nameCYHS2600762 Tianjin Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/04/01New drug · Class 1.1 ZYY-768颗粒 · No verified English nameCXZL2600033 Yang Zi Jiang Pharma Group Jiangsu Long Feng Tang Zhong Yao Co., Ltd. romanized; Nanjing Hai Ling Zhong Yao Pharmaceutical Gong Yi Technology Research Co., Ltd. romanized
2026/04/01New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600060 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2026/04/01New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600059 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2026/04/01New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600058 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2026/04/01New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600057 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2026/04/01New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600056 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2026/04/01New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600055 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2026/04/01New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600054 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2026/04/01New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600053 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2026/04/01New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600052 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2026/04/01New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600051 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2026/04/01New drug · Class 1 LNF2401注射液(皮下注射) · No verified English nameCXSL2600370 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2026/04/01New drug · Class 1 LNF2401注射液(静脉滴注) · No verified English nameCXSL2600369 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2026/04/01New drug · Class 1 CMG2349注射液 · No verified English nameCXSL2600368 Chengdu En Mu Bio Technology Co., Ltd. romanized
2026/04/01New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2600367 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized

56 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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