YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 484 drug applications between 3 June 2026 and 9 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 67 drug names.

2026/06/03 – 2026/06/09

Period
2026/06/03 to 2026/06/09, 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
484
Drugs with new generic filings (by drug name, de-duplicated)
67
Accepted this week, now under review
144

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

484filings, 96 of them generic

By application type

Application typeFilings
Supplement261
Generic96
New drug78
Import37
Unspecified6
Import re-registration6

By drug type

Drug typeFilings
Chemical drug234
TCM166
Therapeutic biologic79
Prophylactic biologic3
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

67 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

283 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized19140
2Novo Nordisk A/S1520
3Eli Lilly and Company1320
4Eli Lilly Nederland B.V.810
5Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized620
6Celgene Corporation a Bristol-Myers Squibb Company610
7Chengdu Hua Sen Ao Rui Pharma Co., Ltd. romanized610
8Jiangsu Hao Sen Pharma Group Co., Ltd. romanized610
9Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized550
10Qilu Pharmaceutical Co., Ltd.530

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

149 this week

AcceptedDrugApplicants
2026/06/09Generic · Class 3 布洛芬去氧肾上腺素片 · No verified English nameCYHS2601350 Kang Zhi Pharma Co., Ltd. romanized
2026/06/09Generic · Class 3 Bilastine Oral SolutionCYHS2601344 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2026/06/09Generic · Class 3 Dexmethylphenidate Hydrochloride TabletsCYHL2600070 Henan Zhong Shuai Pharma Co., Ltd. romanized
2026/06/09New drug · Class 3.3 西妥昔单抗注射液 · No verified English nameCXSL2600622 Shanghai Hong Cheng Pharma Co., Ltd. romanized
2026/06/09New drug · Class 1 注射用QLS2319 · No verified English nameCXSL2600619 Qilu Pharmaceutical Co., Ltd.
2026/06/09New drug · Class 2.2 WRC2301 · No verified English nameCXHL2600684 Jinan Wei Rui Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2026/06/09New drug · Class 2.2 WRC2301 · No verified English nameCXHL2600683 Jinan Wei Rui Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2026/06/08Import · Class 2.2 注射用罗特西普 · No verified English nameJXSS2600051 Celgene Corporation a Bristol-Myers Squibb Company; Patheon Italia S.p.A.; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/06/08Import · Class 2.2 注射用罗特西普 · No verified English nameJXSS2600050 Celgene Corporation a Bristol-Myers Squibb Company; Patheon Italia S.p.A.; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/06/08Import · Class 1 GIA632注射液 · No verified English nameJXSL2600140 Novartis Pharma AG
2026/06/08Generic · Class 3 Doxepin Hydrochloride TabletsCYHS2601336 Shenyang Hua Tai Drug Research Co., Ltd. romanized
2026/06/08Generic · Class 3 Simethicone Chewable TabletsCYHS2601335 Jiangxi Shimei Pharmaceutical Co., Ltd
2026/06/08Generic · Class 3 Pregabalin Orally Disintegrating TabletsCYHS2601334 Shandong Innovation Drug Research and Development Co., Ltd. romanized; Jiangxi Shimei Pharmaceutical Co., Ltd
2026/06/08Generic · Class 3 Pregabalin Orally Disintegrating TabletsCYHS2601333 Shandong Innovation Drug Research and Development Co., Ltd. romanized; Jiangxi Shimei Pharmaceutical Co., Ltd
2026/06/08Generic · Class 3 Pregabalin Orally Disintegrating TabletsCYHS2601332 Shandong Innovation Drug Research and Development Co., Ltd. romanized; Jiangxi Shimei Pharmaceutical Co., Ltd
2026/06/08Generic · Class 3 美洛昔康注射液(III) · No verified English nameCYHS2601331 Health Yuan Pharma Group Co., Ltd. romanized; Health Yuan Hai Bin Pharma Co., Ltd. romanized
2026/06/08Generic · Class 3 Pregabalin Extended release TabletsCYHS2601329 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2026/06/08Generic · Class 3 Pregabalin Extended release TabletsCYHS2601328 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2026/06/08Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601327 Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized
2026/06/08Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2601325 Jiangxi Zhong Ze Yuan Pharmaceuticals Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2026/06/08Generic · Class 3 Timolol Maleate Eye DropsCYHS2601324 Guangdong Nan Guo Pharma Co., Ltd. romanized
2026/06/08New drug · Class 1.1 芪地通便颗粒 · No verified English nameCXZL2600054 Shandong Han Fang Pharmaceutical Co., Ltd. romanized
2026/06/08New drug · Class 1 Pumitamig注射液 · No verified English nameCXSL2600617 Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized; Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized
2026/06/08New drug · Class 1 注射用RT023 · No verified English nameCXSL2600616 Shanghai Ruo Tuo Bio Technology Co., Ltd. romanized
2026/06/08New drug · Class 2.2 西妥昔单抗β注射液 · No verified English nameCXSL2600615 Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized
2026/06/08New drug · Class 1 ZMPB-NK006注射液 · No verified English nameCXSL2600614 Beijing Mei Ou Sai Ao Jin Bio Technology Co., Ltd. romanized
2026/06/08New drug · Class 1 IBR822细胞注射液 · No verified English nameCXSL2600613 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2026/06/08New drug · Class 1 IBR822细胞注射液 · No verified English nameCXSL2600612 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2026/06/08New drug · Class 1 RG002注射液 · No verified English nameCXSL2600611 Ren Jing (Suzhou) Bio Technology Co., Ltd. romanized
2026/06/08New drug · Class 1 CA-301注射液 · No verified English nameCXHL2600682 Yuan Yan Gang Nao Ke Xue Technology (Shanghai) Co., Ltd. romanized; Yuan Yan Yao Gang Sheng Ming Ke Xue Technology (Beijing) Group Co., Ltd. romanized

119 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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