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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 404 drug applications between 28 March 2026 and 3 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 34 drug names.

2026/03/28 – 2026/04/03

Period
2026/03/28 to 2026/04/03, 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
404
Drugs with new generic filings (by drug name, de-duplicated)
34
Accepted this week, now under review
97

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

404filings, 48 of them generic

By application type

Application typeFilings
Supplement257
New drug64
Generic48
Import15
Unspecified11
Import re-registration9

By drug type

Drug typeFilings
Chemical drug179
TCM164
Therapeutic biologic58
Biologic2
Prophylactic biologic1

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

34 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Mirogabalin Besilate Tablets3261
2Tadalafil Tablets3123
3Arginine and Ibuprofen Granules3111
4Linagliptin and Metformin Hydrochloride Extended Release Tablets214
5Carboplatin Injection2110
6Diclofenac Diethylamine Emulgel2120
7Cefditoren Pivoxil Granules2118
8Montelukast Sodium Chewable Tablets214
9Epinastine Hydrochloride Tablets212
10Labetalol Hydrochloride Tablets213

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

235 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized10100
2Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized1010
3Ha Yao Group Bio Gong Cheng Co., Ltd. romanized830
4Jiangsu Ke Lun Pharma Co., Ltd. romanized810
5Hubei Tai Zi Pharma Co., Ltd. romanized770
6Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized660
7Zhejiang Guo Jing Pharma Co., Ltd. romanized610
8Henan Nuo Mei Pharma Co., Ltd. romanized550
9AstraZeneca AB540
10Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized540

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

87 this week

AcceptedDrugApplicants
2026/04/03Import · Class 2.2 注射用维恩妥尤单抗 · No verified English nameJXSL2600091 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2026/04/03Import · Class 2.2 注射用维恩妥尤单抗 · No verified English nameJXSL2600090 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2026/04/03Import · Class 1 Baxdrostat片 · No verified English nameJXHL2600099 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/04/03Generic · Class 3 Ketotifen Fumarate Oral SolutionCYHS2600784 Anhui Yuan Wang Le Huan Pharma Co., Ltd. romanized
2026/04/03New drug · Class 1 GT307注射液 · No verified English nameCXSL2600379 Beijing Sha Li Biopharmaceuticals Co., Ltd. romanized
2026/04/03New drug · Class 1 SAR445877注射用浓溶液 · No verified English nameCXSL2600378 Sai Nuo Fei (Zhongguo) Investment Co., Ltd. romanized
2026/04/03New drug · Class 1 ATTO-1310注射液 · No verified English nameCXSL2600377 Ai Tuo Wei Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/04/03New drug · Class 1 9MW5211注射液 · No verified English nameCXSL2600376 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2026/04/03New drug · Class 1 注射用DXC018 · No verified English nameCXSL2600375 Hangzhou Duo Xi Bio Technology Co., Ltd. romanized
2026/04/03New drug · Class 1 注射用SIM0689 · No verified English nameCXSL2600374 Shanghai Xian Wei Pharmaceuticals Technology Co., Ltd. romanized
2026/04/03New drug · Class 1 艾普美妥司他片 · No verified English nameCXHS2600047 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2026/04/03New drug · Class 1 艾普美妥司他片 · No verified English nameCXHS2600046 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2026/04/03New drug · Class 1 伊托法替布软膏 · No verified English nameCXHS2600045 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2026/04/03New drug · Class 1 D-0120-NA片 · No verified English nameCXHL2600406 Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized
2026/04/03New drug · Class 1 VC005凝胶 · No verified English nameCXHL2600405 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2026/04/03New drug · Class 2.2 优替德隆胶囊 · No verified English nameCXHL2600404 Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized; Beijing Hua Hao Zhong Tian Biopharmaceuticals Co., Ltd. romanized
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.

57 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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