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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 361 drug applications between 5 September 2023 and 11 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 64 drug names.

2023/09/05 – 2023/09/11

Period
2023/09/05 to 2023/09/11, 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
361
Drugs with new generic filings (by drug name, de-duplicated)
64
Accepted this week, now under review
0

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

361filings, 78 of them generic

By application type

Application typeFilings
Supplement185
Generic78
New drug47
Import24
Import re-registration21
Unspecified6

By drug type

Drug typeFilings
Chemical drug268
TCM62
Therapeutic biologic25
Prophylactic biologic5
In vitro diagnostic reagent1

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

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Amoxicillin Sodium for Injection520
2Lidocaine and Prilocaine Cream2224
3复方聚乙二醇电解质散(儿童型) · No verified English name222
4Formoterol Fumarate Inhalation Solution225
5Pentoxifylline Injection223
6Eltrombopag Olamine Tablets221
7Metaraminol Tartrate Injection222
8Phloroglucinol Injection222
9Nicorandil for Injection211
10Bromfenac Sodium Eye Drops217

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

220 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1NAPP PHARMACEUTICALS LIMITED1510
2Haerbin Tong Yi Tang Pharma Co., Ltd. romanized11110
3Shanxi Zhen Dong Wu He Tang Pharmaceutical Co., Ltd. romanized660
4Shen Wei Pharma Group Co., Ltd. romanized660
5Eli Lilly and Company610
6Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized550
7Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized550
8Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized530
9Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized510
10Guangxi Zhuang Zu Zi Zhi Qu Drug Research Institute 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

97 this week

AcceptedDrugApplicants
2023/09/11Import · Class 2.2 Talquetamab注射液 · No verified English nameJXSL2300168 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/09/11Import · Class 2.2 Talquetamab注射液 · No verified English nameJXSL2300167 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/09/11Import · Class 2.2 Teclistamab 注射液 · No verified English nameJXSL2300166 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/09/11Import · Class 2.2 Teclistamab 注射液 · No verified English nameJXSL2300165 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/09/11Generic · Class 3 立他司特滴眼液 · No verified English nameCYHS2302444 Chengdu Kang Hong Pharma Group Co., Ltd. romanized; Chengdu Pusch Pharmaceutical Co., Ltd.
2023/09/11Generic · Class 3 Pentoxifylline InjectionCYHS2302437 Hua Zhong Pharma Co., Ltd. romanized
2023/09/11Generic · Class 3 Pirfenidone TabletsCYHS2302435 Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized
2023/09/11New drug · Class 1 注射用IAE0972 · No verified English nameCXSL2300602 Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized
2023/09/11New drug · Class 1 GS1-144片 · No verified English nameCXHL2300977 Changchun Jin Sai Pharma Co., Ltd. romanized
2023/09/11New drug · Class 1 GS1-144片 · No verified English nameCXHL2300976 Changchun Jin Sai Pharma Co., Ltd. romanized
2023/09/11New drug · Class 1 GS1-144片 · No verified English nameCXHL2300975 Changchun Jin Sai Pharma Co., Ltd. romanized
2023/09/11New drug · Class 1 BL0020注射液 · No verified English nameCXHL2300974 Shanghai Bi Ling Bio Technology Co., Ltd. romanized
2023/09/11New drug · Class 1 GK201胶囊 · No verified English nameCXHL2300973 Suzhou Guo Kuang Pharmaceuticals Technology Co., Ltd. romanized
2023/09/11New drug · Class 1 GK201胶囊 · No verified English nameCXHL2300972 Suzhou Guo Kuang Pharmaceuticals Technology Co., Ltd. romanized
2023/09/09Import · Class 1 GDC-9545 · No verified English nameJXHL2300209 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/09/09Generic · Class 3 Pentoxifylline InjectionCYHS2302430 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2023/09/09Generic · Class 3 复方匹可硫酸钠颗粒 · No verified English nameCYHS2302428 Jiangxi Ke Rui Pharma Co., Ltd. romanized
2023/09/09Generic · Class 3 Epalrestat TabletsCYHS2302427 Hebei Rui Sen Pharma Co., Ltd. romanized
2023/09/09Generic · Class 3 Indobufen TabletsCYHS2302426 Beijing Wei Lin Heng Chang Pharmaceuticals Technology Co., Ltd. romanized; Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/09/09New drug · Class 3.3 西妥昔单抗注射液 · No verified English nameCXSS2300075 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2023/09/09New drug · Class 1 HSK36357胶囊 · No verified English nameCXHL2300971 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2023/09/09New drug · Class 1 HSK36357胶囊 · No verified English nameCXHL2300970 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2023/09/09New drug · Class 2.2 盐酸达泊西汀口溶膜 · No verified English nameCXHL2300969 Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized
2023/09/09New drug · Class 1 注射用XCCS605B · No verified English nameCXHL2300968 Shanghai Hua Yu Bio Technology Co., Ltd. romanized
2023/09/08Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSS2300078 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2023/09/08Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSS2300077 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2023/09/08Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300208 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/09/08Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300207 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/09/08Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300206 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/09/08Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300205 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.

67 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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