YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 659 drug applications between 7 May 2026 and 13 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 66 drug names.

2026/05/07 – 2026/05/13

Period
2026/05/07 to 2026/05/13, 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
659
Drugs with new generic filings (by drug name, de-duplicated)
66
Accepted this week, now under review
161

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

659filings, 92 of them generic

By application type

Application typeFilings
Supplement373
New drug110
Generic92
Import53
Unspecified21
Import re-registration10

By drug type

Drug typeFilings
Chemical drug311
TCM229
Therapeutic biologic99
Biologic17
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

66 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

365 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized23200
2AstraZeneca AB2130
3Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized1280
4Karuna Therapeutics Inc. a Bristol Myers Squibb Company820
5Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized660
6Pfizer Inc.650
7Eli Lilly and Company630
8Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
9Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized610
10Novo Nordisk A/S550

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

187 this week

AcceptedDrugApplicants
2026/05/13Import · Class 2.2 萨特利珠单抗注射液 · No verified English nameJXSS2600042 Roche Pharma (Schweiz) AG; Utsunomiya Plant of Chugai Pharma Manufacturing Co. Ltd.; Roche (China) Holding Ltd.
2026/05/13Import · Class 1 Seltorexant薄膜包衣片 · No verified English nameJXHL2600175 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/05/13Import · Class 2.2; 2.4 BMS-986519肠溶胶囊 · No verified English nameJXHL2600174 Karuna Therapeutics Inc. a Bristol Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/05/13Import · Class 2.2; 2.4 BMS-986519肠溶胶囊 · No verified English nameJXHL2600173 Karuna Therapeutics Inc. a Bristol Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/05/13Import · Class 2.2; 2.4 BMS-986519肠溶胶囊 · No verified English nameJXHL2600172 Karuna Therapeutics Inc. a Bristol Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/05/13Import · Class 2.2; 2.4 BMS-986519肠溶胶囊 · No verified English nameJXHL2600171 Karuna Therapeutics Inc. a Bristol Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/05/13Import · Class 1 FOG-001注射液 · No verified English nameJXHL2600170 Parabilis Medicines Inc.; Parabilis Medicines (Shanghai) Ltd. Co
2026/05/13Import · Class 2.4 BMS-986510胶囊 · No verified English nameJXHL2600169 Karuna Therapeutics Inc. a Bristol Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/05/13Import · Class 2.4 BMS-986510胶囊 · No verified English nameJXHL2600168 Karuna Therapeutics Inc. a Bristol Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/05/13Import · Class 2.4 BMS-986510胶囊 · No verified English nameJXHL2600167 Karuna Therapeutics Inc. a Bristol Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/05/13Import · Class 2.4 BMS-986510胶囊 · No verified English nameJXHL2600166 Karuna Therapeutics Inc. a Bristol Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/05/13Import · Class 1 Olomorasib胶囊 · No verified English nameJXHL2600165 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/05/13Import · Class 1 Olomorasib胶囊 · No verified English nameJXHL2600164 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/05/13Generic · Class 3 Sodium Lactate Ringer's Irrigation SolutionCYHS2601118 Guangdong Ke Hong Pharma Co., Ltd. romanized
2026/05/13Generic · Class 3 Amisulpride InjectionCYHS2601115 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2026/05/13Generic · Class 3 比拉斯汀口崩片 · No verified English nameCYHS2601114 Zhejiang Kang De Pharma Group Co., Ltd. romanized
2026/05/13Generic · Class 3 Ibuprofen InjectionCYHS2601110 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2026/05/13Generic · Class 3 Ibuprofen InjectionCYHS2601109 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2026/05/13Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2601108 Zhejiang Di Er Pharma Co., Ltd. romanized
2026/05/13Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2601107 Zhejiang Di Er Pharma Co., Ltd. romanized
2026/05/13Generic · Class 3 Epalrestat TabletsCYHS2601105 Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized
2026/05/13New drug · Class 1.1 柴芪固溺丸 · No verified English nameCXZL2600043 Shanghai Shou Zheng Zhong Pharmaceuticals Research Co., Ltd. romanized
2026/05/13New drug · Class 1 注射用IMD1828 · No verified English nameCXSL2600517 Shanghai Ying Mai De Medical Technology Co., Ltd. romanized
2026/05/13New drug · Class 1 注射用SHR-A2009 · No verified English nameCXSL2600515 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/05/13New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2600514 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/05/13New drug · Class 1 IBR900细胞注射液 · No verified English nameCXSL2600513 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2026/05/13New drug · Class 1 IBR900细胞注射液 · No verified English nameCXSL2600512 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2026/05/13New drug · Class 1 IBR900细胞注射液 · No verified English nameCXSL2600511 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2026/05/13New drug · Class 1 IBR900细胞注射液 · No verified English nameCXSL2600510 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2026/05/13New drug · Class 1 IBR900细胞注射液 · No verified English nameCXSL2600509 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized

157 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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