YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 260 drug applications between 27 October 2021 and 2 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 29, covering 25 drug names.

2021/10/27 – 2021/11/02

Period
2021/10/27 to 2021/11/02, 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
260
Drugs with new generic filings (by drug name, de-duplicated)
25
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

260filings, 29 of them generic

By application type

Application typeFilings
Supplement148
New drug36
Generic29
Import re-registration22
Import20
Unspecified5

By drug type

Drug typeFilings
Chemical drug187
TCM38
Therapeutic biologic26
Prophylactic biologic8
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

25 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ozagrel Sodium Injection213
2Olaparib Tablets210
3Pregabalin Capsules2112
4Lenvatinib Mesilate Capsules214
5Acetylcysteine Granules114
6Epalrestat Tablets111
7Rivaroxaban Tablets113
8Linaclotide Capsules1113
9Capecitabine Tablets110
10Folic Acid Tablets1112

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

146 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
5Dong E A Hua Medical Technology Co., Ltd. Pharma Branch romanized620
6Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized610
7Shaanxi Dong Ke Pharmaceutical Co., Ltd. romanized550
8AstraZeneca AB530
9YaoPharma Co., Ltd.522
10Sanofi-Aventis Groupe510

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

63 this week

AcceptedDrugApplicants
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.
2021/11/01New drug · Class 1.1 脑伤乐生颗粒 · No verified English nameCXZS2101005 Shenzhen Shi Sha Song Industrial Co., Ltd. romanized; Henan Tian Fang Pharma Zhong Yao Co., Ltd. romanized
2021/11/01New drug · Class 1 AK104注射液 · No verified English nameCXSL2101405 Kang Fang Pharma Co., Ltd. romanized
2021/11/01New drug · Class 1 AK104注射液 · No verified English nameCXSL2101404 Kang Fang Pharma Co., Ltd. romanized
2021/11/01New drug · Class 1 AK112注射液 · No verified English nameCXSL2101403 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/11/01New drug · Class 1 GR1501注射液 · No verified English nameCXSL2101401 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2021/11/01New drug · Class 1 重组人源化抗PD-1单克隆抗体注射液 · No verified English nameCXSL2101400 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2021/11/01New drug · Class 1 ASKG712注射液 · No verified English nameCXSL2101396 Suzhou Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized
2021/11/01New drug · Class 1 重组人源化抗PD-1单克隆抗体注射液 · No verified English nameCXSL2101395 Tai Zhou Han Zhong Biopharmaceuticals Co., Ltd. romanized
2021/11/01New drug · Class 2.2 吸附无细胞百(组分)白破联合疫苗 · No verified English nameCXSL2101393 Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized
2021/11/01New drug · Class 1 HLX35 · No verified English nameCXSL2101389 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2021/11/01New drug · Class 1 SHR3680片 · No verified English nameCXHS2101050 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/11/01New drug · Class 1 CBP-307胶囊 · No verified English nameCXHL2101612 Suzhou Kang Nai De Biopharmaceuticals Co., Ltd. romanized
2021/11/01New drug · Class 1 CBP-307胶囊 · No verified English nameCXHL2101611 Suzhou Kang Nai De Biopharmaceuticals Co., Ltd. romanized
2021/11/01New drug · Class 2.4 Apatinib Mesylate TabletsCXHL2101607 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/10/29Import · Class 3.1 纳武利尤单抗注射液 · No verified English nameJXSS2101028 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China)Investment Co. Ltd
2021/10/29Import · Class 3.1 纳武利尤单抗注射液 · No verified English nameJXSS2101027 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China)Investment Co. Ltd

33 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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