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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 255 drug applications between 29 October 2021 and 4 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 30, covering 27 drug names.

2021/10/29 – 2021/11/04

Period
2021/10/29 to 2021/11/04, 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
255
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

255filings, 30 of them generic

By application type

Application typeFilings
Supplement162
New drug31
Generic30
Import16
Import re-registration15
Unspecified1

By drug type

Drug typeFilings
Chemical drug175
TCM40
Therapeutic biologic34
Prophylactic biologic6

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
4ω-3 鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English name110
5Epalrestat Tablets111
6Rivaroxaban Tablets113
7Linaclotide Capsules1113
8Capecitabine Tablets110
9Folic Acid Tablets1112
10Ipratropium Bromide Inhalation Solution112

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

131 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Yi Pu Bio Technology Co., Ltd. romanized990
2Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized821
3Fei Sen You Si Ka Bi Hua Rui Pharmaceutical Co., Ltd. romanized810
4Novartis Pharma Schweiz AG740
5Guangdong Ke Lun Pharma Co., Ltd. romanized720
6Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized710
7Dong E A Hua Medical Technology Co., Ltd. Pharma Branch romanized620
8Hainan Tong Yong San Yang Pharma Co., Ltd. romanized620
9Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized610
10Shaanxi Dong Ke Pharmaceutical Co., Ltd. romanized550

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

56 this week

AcceptedDrugApplicants
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
2021/11/02New drug · Class 1 BYS10片 · No verified English nameCXHL2101628 Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized
2021/11/02New drug · Class 1 BYS10片 · No verified English nameCXHL2101627 Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized
2021/11/01Import · Class 1 DS-1062a · No verified English nameJXSL2101122 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2021/11/01Import · Class 1 MRTX849片 · No verified English nameJXHL2101227 Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2021/11/01Import · Class 1 MRTX849片 · No verified English nameJXHL2101226 Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2021/11/01Generic · Class 3 Tirofiban Hydrochloride InjectionCYHS2101951 Guangzhou Man Xiang Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.

26 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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