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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 228 drug applications between 30 October 2021 and 5 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 32, covering 27 drug names.

2021/10/30 – 2021/11/05

Period
2021/10/30 to 2021/11/05, 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
228
Drugs with new generic filings (by drug name, de-duplicated)
27
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

228filings, 32 of them generic

By application type

Application typeFilings
Supplement136
Generic32
New drug25
Import18
Import re-registration13
Unspecified4

By drug type

Drug typeFilings
Chemical drug168
Therapeutic biologic35
TCM20
Prophylactic biologic5

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

27 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ozagrel Sodium Injection213
2Amlodipine Besylate and Atorvastatin Calcium Tablets212
3Remifentanil Hydrochloride for Injection212
4Sodium Hyaluronate Eye Drops2130
5阿普米司特片 · No verified English name213
6ω-3 鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English name110
7丙酸氟替卡松吸入粉雾剂 · No verified English name111
8Rivaroxaban Tablets113
9Linaclotide Capsules1113
10Desogestrel and Ethinylestradiol Tablets110

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

127 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fei Sen You Si Ka Bi Hua Rui Pharmaceutical Co., Ltd. romanized810
2Guangdong Ke Lun Pharma Co., Ltd. romanized720
3Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized710
4Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized710
5Hainan Tong Yong San Yang Pharma Co., Ltd. romanized620
6Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized550
7Novartis Pharma Schweiz AG520
8UCB Pharma SA520
9Liu He Zhang Long Pharmaceutical Co., Ltd. romanized440
10Chongqing Duo Dai Pharmaceuticals Technology 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

50 this week

AcceptedDrugApplicants
2021/11/05Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSL2101125 MedImmune LLC; AstraZeneca Investment (China) Co. Limited
2021/11/05Import · Class 2.2 阿普唑仑吸入粉剂 · No verified English nameJXHL2101234 UCB Pharma SA; UCB Trading (Shanghai) Co. Ltd.
2021/11/05Import · Class 1 BBP-398 胶囊 · No verified English nameJXHL2101233 Navire Pharma Inc.; Shanghai LianBio Development Co. Ltd.
2021/11/05Import · Class 1 BBP-398胶囊 · No verified English nameJXHL2101232 Navire Pharma Inc.; Shanghai LianBio Development Co. Ltd.
2021/11/05Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2101978 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2021/11/05Generic · Class 3 丙酸氟替卡松吸入粉雾剂 · No verified English nameCYHL2101034 Run Sheng Pharma Co., Ltd. romanized
2021/11/04Generic · Class 3 ω-3 鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English nameCYHL2101035 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2021/11/04New drug · Class 3.3 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSS2101046 Beijing Min Hai Bio Technology Co., Ltd. romanized
2021/11/04New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSS2101045 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/11/04New drug · Class 1 TWP-103注射液 · No verified English nameCXSL2101402 Tai Ze Hui Kang Biopharmaceuticals Co., Ltd. romanized
2021/11/04New drug · Class 1 KN056注射液 · No verified English nameCXSL2101386 Suzhou Kang Ning Jie Rui Bio Technology Co., Ltd. romanized
2021/11/04New drug · Class 1 WTS-007胶囊 · No verified English nameCXHL2101624 Hangzhou Wu Tong Shu Pharma Co., Ltd. romanized
2021/11/04New drug · Class 1 WTS-007胶囊 · No verified English nameCXHL2101623 Hangzhou Wu Tong Shu Pharma Co., Ltd. romanized
2021/11/04New drug · Class 1 WTS-007胶囊 · No verified English nameCXHL2101622 Hangzhou Wu Tong Shu Pharma Co., Ltd. romanized
2021/11/03Import · Class 3.1 西妥昔单抗注射液 · No verified English nameJXSS2101029 Merck Europe B.V.; Merck Healthcare KGaA; Merck Serono Co. Ltd.
2021/11/03Import · Class 1 3D-197注射液 · No verified English nameJXSL2101123 3D Medicines Inc.; 3D Medicines (Shanghai) Co. Ltd.
2021/11/03Import · Class 2.1 注射用托伐普坦磷酸钠 · No verified English nameJXHL2101231 Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Insititute
2021/11/03Import · Class 2.1 注射用托伐普坦磷酸钠 · No verified English nameJXHL2101230 Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Insititute
2021/11/03Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2101958 Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2021/11/03Generic · Class 3 Remifentanil Hydrochloride for InjectionCYHL2101032 Jiangsu En Hua Pharma Co., Ltd. romanized
2021/11/03Generic · Class 3 Remifentanil Hydrochloride for InjectionCYHL2101031 Jiangsu En Hua Pharma Co., Ltd. romanized
2021/11/03New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2101408 Shanghai Mai Ke Kang Bio Technology Co., Ltd. romanized; Chengdu Mai Ke Kang Bio Technology Co., Ltd. romanized
2021/11/02Import · Class 1 Afuresertib片 · No verified English nameJXHL2101229 Laekna Limited; Laekna Therapeutics Shanghai Co. Ltd.
2021/11/02Import · Class 1 Afuresertib片 · No verified English nameJXHL2101228 Laekna Limited; Laekna Therapeutics Shanghai Co. Ltd.
2021/11/02Generic · Class 3 Trihexyphenidyl Hydrochloride TabletsCYHS2101959 Beijing Si Li An Pharma Co., Ltd. romanized
2021/11/02Generic · Class 3 Dexrazoxane for InjectionCYHS2101956 Guangdong Zhong Run Drug Research and Development Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2021/11/02Generic · Class 3 Ozagrel Sodium InjectionCYHS2101939 Guangxi Ming Lei Wei Sheng Pharmaceutical Co., Ltd. romanized
2021/11/02Generic · Class 3 Ozagrel Sodium InjectionCYHS2101938 Guangxi Ming Lei Wei Sheng Pharmaceutical Co., Ltd. romanized
2021/11/02Generic · Class 3 Bismuth subcitrate potassium, Metronidazole and Tetracycline Hydrochloride CapsulesCYHS2101929 Hubei Jing Jiang Yuan Pharmaceutical Co., Ltd. romanized
2021/11/02New drug · Class 1 IBI110 · No verified English nameCXSL2101406 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized

20 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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