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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 359 drug applications between 12 October 2023 and 18 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 101, covering 70 drug names.

2023/10/12 – 2023/10/18

Period
2023/10/12 to 2023/10/18, 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
359
Drugs with new generic filings (by drug name, de-duplicated)
70
Accepted this week, now under review
1

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

359filings, 101 of them generic

By application type

Application typeFilings
Supplement161
Generic101
New drug69
Import16
Import re-registration7
Unspecified5

By drug type

Drug typeFilings
Chemical drug247
TCM68
Therapeutic biologic40
Prophylactic biologic3
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

70 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Diquafosol Sodium Eye Drops655
2Famotidine Injection438
3Lactulose Oral Solution3234
4小儿复方氨基酸注射液(19AA-I) · No verified English name312
5Ixazomib Citrate Capsules317
6盐酸左沙丁胺醇雾化吸入溶液 · No verified English name312
7Oseltamivir Phosphate For Oral Suspension312
8Diprophylline Injection227
9Ezetimibe Tablets224
10Lidocaine and Prilocaine Cream2224

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

224 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Jin Xing Pharmaceutical Co., Ltd. romanized1090
2Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized830
3Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized636
4Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized550
5Guangxi Hong Ji Pharma Group Co., Ltd. romanized440
6Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized440
7Pfizer Europe MA EEIG430
8ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.434
9Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized420
10Wuhan Lang Lai Technology Development Co., Ltd. romanized420

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

124 this week

AcceptedDrugApplicants
2023/10/18Import · Class 1 Sisunatovir 片 · No verified English nameJXHL2300255 Pfizer Inc.; Pfizer Investment CO. Ltd
2023/10/18Generic · Class 3 富马酸酮替芬滴眼液 · No verified English nameCYHS2302799 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2023/10/18Generic · Class 3 Aminophylline InjectionCYHS2302798 Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/10/18Generic · Class 3 Calcium Acetate Oral SolutionCYHS2302797 Hebei Hua Chen Pharma Group Co., Ltd. romanized
2023/10/18Generic · Class 3 Acetylcysteine InjectionCYHS2302796 Shaanxi Li Cai Pharma Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/10/18Generic · Class 3 Diprophylline InjectionCYHS2302795 Xizang Hai Jin Pharma Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2023/10/18New drug · Class 1 BD211自体CD34+造血干细胞注射液 · No verified English nameCXSL2300710 Shanghai Ben Dao Ji Yin Technology Co., Ltd. romanized
2023/10/18New drug · Class 2.2 赛帕利单抗注射液 · No verified English nameCXSL2300709 Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2023/10/18New drug · Class 2.2 赛帕利单抗注射液 · No verified English nameCXSL2300708 Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2023/10/18New drug · Class 1 Domvanalimab注射液 · No verified English nameCXSL2300707 Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2023/10/18New drug · Class 1 Domvanalimab注射液 · No verified English nameCXSL2300706 Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2023/10/18New drug · Class 1 Tinlarebant 片 · No verified English nameCXHL2301124 Bei Liang Sheng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized
2023/10/18New drug · Class 1 TQB3909片 · No verified English nameCXHL2301123 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/10/18New drug · Class 1 TQB3909片 · No verified English nameCXHL2301122 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/10/18New drug · Class 1 TQB3702片 · No verified English nameCXHL2301121 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/10/17Generic · Class 3 Timolol Maleate Eye DropsCYHS2302790 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/10/17Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302783 Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized
2023/10/17Generic · Class 3 Famotidine InjectionCYHS2302780 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2023/10/17New drug · Class 1 ZG005粉针剂 · No verified English nameCXSL2300705 Name not romanized
2023/10/17New drug · Class 1 ZG005粉针剂 · No verified English nameCXSL2300704 Name not romanized
2023/10/17New drug · Class 1 HSK21542注射液 · No verified English nameCXHS2300094 Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2023/10/17New drug · Class 1 YR001软膏 · No verified English nameCXHL2301120 Hangzhou Yi Rui Pharmaceuticals Technology Co., Ltd. romanized
2023/10/17New drug · Class 1 YR001软膏 · No verified English nameCXHL2301119 Hangzhou Yi Rui Pharmaceuticals Technology Co., Ltd. romanized
2023/10/16Import · Class 1 DS-7011a · No verified English nameJXSL2300185 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2023/10/16New drug · Class 1 KAL-002 · No verified English nameCXSL2300703 Sichuan Yan Yang Bio Technology Co., Ltd. romanized
2023/10/16New drug · Class 1 KAL-002 · No verified English nameCXSL2300702 Sichuan Yan Yang Bio Technology Co., Ltd. romanized
2023/10/14Import · Class 1 Tarlatamab · No verified English nameJXSL2300184 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2023/10/14Import · Class 1 Tarlatamab · No verified English nameJXSL2300183 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2023/10/14Import · Class 1 Tarlatamab · No verified English nameJXSL2300182 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2023/10/14Generic · Class 3 氟[18F]化钠注射液 · No verified English nameCYHS2302776 Nanjing Jiang Yuan An Di Ke Zheng Dian Zi Research Development Co., Ltd. romanized

94 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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