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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 451 drug applications between 5 June 2026 and 11 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 57 drug names.

2026/06/05 – 2026/06/11

Period
2026/06/05 to 2026/06/11, 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
451
Drugs with new generic filings (by drug name, de-duplicated)
57
Accepted this week, now under review
136

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

451filings, 90 of them generic

By application type

Application typeFilings
Supplement246
Generic90
New drug77
Import27
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug229
TCM143
Therapeutic biologic78
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

57 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

264 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1520
2Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized870
3Eli Lilly and Company830
4Jiangsu En Hua Pharma Co., Ltd. romanized833
5Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized660
6Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized623
7Amgen Inc.610
8Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized550
9Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized550
10Shen Zhou Xi Bao Gong Cheng 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

137 this week

AcceptedDrugApplicants
2026/06/11Import · Class 2.4 Elafibranor片 · No verified English nameJXHL2600215 Ipsen Bioscience Inc.; Ipsen (Shanghai) Innovation Pharmaceutical Co. Ltd
2026/06/11Generic · Class 3 Chloroprocaine Hydrochloride InjectionCYHS2601393 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2026/06/11Generic · Class 3 Chloroprocaine Hydrochloride InjectionCYHS2601392 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2026/06/11Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2601389 Anhui Kang Rong Pharma Co., Ltd. romanized
2026/06/11Generic · Class 3 Bumetanide InjectionCYHS2601384 Dan Dong Yi Chuang Pharma Co., Ltd. romanized
2026/06/11Generic · Class 3 Bumetanide InjectionCYHS2601382 Dan Dong Yi Chuang Pharma Co., Ltd. romanized
2026/06/11Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2601380 Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2026/06/11Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2601379 Jiangsu Shen Hua Pharma Co., Ltd. romanized
2026/06/11New drug · Class 3.1 苓桂术甘汤颗粒 · No verified English nameCXZS2600031 Changsha Xin Lin Pharmaceutical Co., Ltd. romanized
2026/06/11New drug · Class 3.3 德谷门冬双胰岛素注射液 · No verified English nameCXSS2600092 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2026/06/11New drug · Class 3.3 德谷门冬双胰岛素注射液 · No verified English nameCXSS2600091 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2026/06/11New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSS2600090 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized
2026/06/11New drug · Class 1 HS-IT101注射液 · No verified English nameCXSL2600631 Qingdao Zhong Sai Bo Man Bio Technology Co., Ltd. romanized
2026/06/11New drug · Class 1 SCTB10注射液 · No verified English nameCXSL2600630 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/06/11New drug · Class 1 注射用AK157D1 · No verified English nameCXSL2600629 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2026/06/11New drug · Class 1 HY001N细胞注射液 · No verified English nameCXSL2600628 He Yuan Bio Technology Co., Ltd. romanized; Guangdong He Yuan Biopharmaceuticals Co., Ltd. romanized
2026/06/11New drug · Class 1 BGM0504注射液 · No verified English nameCXHS2600089 Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2026/06/11New drug · Class 1 BGM0504注射液 · No verified English nameCXHS2600088 Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2026/06/11New drug · Class 1 BGM0504注射液 · No verified English nameCXHS2600087 Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2026/06/11New drug · Class 1 BGM0504注射液 · No verified English nameCXHS2600086 Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2026/06/11New drug · Class 1 YKYY033注射液 · No verified English nameCXHL2600704 Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized
2026/06/11New drug · Class 1 YKYY033注射液 · No verified English nameCXHL2600703 Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized
2026/06/11New drug · Class 1 YKYY033注射液 · No verified English nameCXHL2600702 Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized
2026/06/11New drug · Class 2.2; 2.4 WTITD003片 · No verified English nameCXHL2600701 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized
2026/06/11New drug · Class 2.2; 2.4 WTITD003片 · No verified English nameCXHL2600700 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized
2026/06/11New drug · Class 2.2; 2.4 甲硝唑滴眼液 · No verified English nameCXHL2600699 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2026/06/11New drug · Class 2.2; 2.4 甲硝唑滴眼液 · No verified English nameCXHL2600698 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2026/06/11New drug · Class 1 TB-B002D注射液 · No verified English nameCXHL2600697 Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized
2026/06/11New drug · Class 1 TB-B002D注射液 · No verified English nameCXHL2600696 Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized
2026/06/11New drug · Class 2.4 Pantoprazole Sodium For InjectionCXHL2600695 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized

107 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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