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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 463 drug applications between 10 October 2023 and 16 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 118, covering 82 drug names.

2023/10/10 – 2023/10/16

Period
2023/10/10 to 2023/10/16, 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
463
Drugs with new generic filings (by drug name, de-duplicated)
82
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

463filings, 118 of them generic

By application type

Application typeFilings
Supplement219
Generic118
New drug87
Import26
Import re-registration7
Unspecified6

By drug type

Drug typeFilings
Chemical drug332
TCM70
Therapeutic biologic53
Prophylactic biologic7
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

82 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Diquafosol Sodium Eye Drops655
2Edoxaban Tosilate Tablets629
3Oseltamivir Phosphate For Oral Suspension422
4Lactulose Oral Solution3234
5Famotidine Injection328
6Nicorandil for Injection321
7Minoxidil Liniment3252
8小儿复方氨基酸注射液(19AA-I) · No verified English name312
9盐酸左沙丁胺醇雾化吸入溶液 · No verified English name312
10Ezetimibe Tablets224

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

262 companies with new acceptances; top 10 listed

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

156 this week

AcceptedDrugApplicants
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
2023/10/14Generic · Class 3 Lanthanum Carbonate Hydrate GranulesCYHS2302774 Hunan Ming Rui Pharmaceutical Co., Ltd. romanized
2023/10/14Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2302769 Sui Cheng Pharma Co., Ltd. romanized; Zhengzhou Zhi He Pharma Co., Ltd. romanized
2023/10/14Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2302768 Sui Cheng Pharma Co., Ltd. romanized; Zhengzhou Zhi He Pharma Co., Ltd. romanized
2023/10/14Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2302767 Sui Cheng Pharma Co., Ltd. romanized; Zhengzhou Zhi He Pharma Co., Ltd. romanized
2023/10/14Generic · Class 3 Timolol Maleate Eye DropsCYHS2302766 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2023/10/14Generic · Class 3 小儿复方氨基酸注射液(19AA-I) · No verified English nameCYHS2302763 Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2023/10/14Generic · Class 3 小儿复方氨基酸注射液(19AA-I) · No verified English nameCYHS2302762 Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2023/10/14Generic · Class 3 小儿复方氨基酸注射液(19AA-I) · No verified English nameCYHS2302761 Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2023/10/14Generic · Class 3 Minoxidil LinimentCYHS2302758 Guangdong Yi Kang Na Si Biopharmaceuticals Technology Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2023/10/14Generic · Class 3 Minoxidil LinimentCYHS2302757 Guangdong Yi Kang Na Si Biopharmaceuticals Technology Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2023/10/14New drug · Class 2.1 万通筋骨巴布膏 · No verified English nameCXZS2300021 Tong Hua Wan Tong Pharma Co., Ltd. romanized
2023/10/14New drug · Class 1 注射用ZHB114 · No verified English nameCXSL2300701 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized; Changzhou Qian Hong Sheng Hua Pharmaceutical Co., Ltd. romanized
2023/10/14New drug · Class 1 IBI343 · No verified English nameCXSL2300700 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/10/14New drug · Class 1 KL003细胞注射液 · No verified English nameCXSL2300699 Kang Lin Bio Technology (Hangzhou) Co., Ltd. romanized
2023/10/14New drug · Class 1 ZX2010注射液 · No verified English nameCXSL2300698 Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized
2023/10/14New drug · Class 1 SC0011片 · No verified English nameCXHL2301118 Wuxi Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized
2023/10/14New drug · Class 2.2 LPC-013口溶膜 · No verified English nameCXHL2301117 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/10/14New drug · Class 2.2 LPC-013口溶膜 · No verified English nameCXHL2301116 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/10/14New drug · Class 1 BT-114143注射液 · No verified English nameCXHL2301115 Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized
2023/10/14New drug · Class 1 TNP-2092软膏 · No verified English nameCXHL2301114 Dan Nuo Pharmaceuticals (Zhong Shan) Co., Ltd. romanized
2023/10/14New drug · Class 1 BT-114143注射液 · No verified English nameCXHL2301113 Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized
2023/10/14New drug · Class 1 DA818胶囊 · No verified English nameCXHL2301112 Chengdu Di Ao Jiu Hong Pharmaceutical Factory romanized
2023/10/14New drug · Class 1 DA818胶囊 · No verified English nameCXHL2301111 Chengdu Di Ao Jiu Hong Pharmaceutical Factory romanized

126 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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