YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 258 drug applications between 25 October 2021 and 31 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 28 drug names.

2021/10/25 – 2021/10/31

Period
2021/10/25 to 2021/10/31, 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
258
Drugs with new generic filings (by drug name, de-duplicated)
28
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

258filings, 36 of them generic

By application type

Application typeFilings
Supplement137
New drug42
Generic36
Import24
Import re-registration15
Unspecified4

By drug type

Drug typeFilings
Chemical drug184
TCM39
Therapeutic biologic29
Prophylactic biologic5
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

28 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Moxifloxacin Hydrochloride And Sodium Chloride Injection2210
2Olaparib Tablets210
3Levofloxacin Eye Drops2116
4Torsemide Injection211
5Pregabalin Capsules2112
6Lenvatinib Mesilate Capsules214
7Oxytocin Injection218
8酒石酸伐尼克兰片 · No verified English name213
9Acetylcysteine Granules114
10Epalrestat Tablets111

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

147 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Yi Pu Bio Technology Co., Ltd. romanized990
2Dong E A Hua Medical Technology Co., Ltd. Pharma Branch romanized620
3Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized610
4Shaanxi Dong Ke Pharmaceutical Co., Ltd. romanized550
5AstraZeneca AB530
6Hainan Jiu Chang Pharmaceutical Co., Ltd. romanized530
7H. Lundbeck A/S520
8Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized520
9Sanofi-Aventis Groupe510
10Boehringer Ingelheim International GmbH420

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

71 this week

AcceptedDrugApplicants
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
2021/10/29Generic · Class 3 Folic Acid TabletsCYHS2101949 Zhejiang Bai Ao Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2021/10/29Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2101947 Hebei Chuang Jian Pharma Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2021/10/29Generic · Class 3 Epalrestat TabletsCYHS2101945 Xian Wan Long Pharmaceutical Co., Ltd. romanized
2021/10/29Generic · Class 3 Clonidine hydrochloride extended-release tabletsCYHL2101033 Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized
2021/10/29New drug · Class 1 PD-1基因定制活化T细胞注射液 · No verified English nameCXSL2101398 Anhui Ke Dun Bio Technology Co., Ltd. romanized
2021/10/29New drug · Class 1 注射用MRG003 · No verified English nameCXSL2101397 Shanghai Mei Ya Ke Bio Technology Co., Ltd. romanized
2021/10/29New drug · Class 2.1; 2.2 注射用RF16001 · No verified English nameCXHL2101621 Beijing Hui Li Technology Co., Ltd. romanized; Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/10/29New drug · Class 1 JMKX001899片 · No verified English nameCXHL2101620 Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2021/10/29New drug · Class 1 JMKX001899片 · No verified English nameCXHL2101619 Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2021/10/29New drug · Class 2.4 盐酸米托蒽醌脂质体注射液 · No verified English nameCXHL2101618 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2021/10/28Import · Class 1 MEDI3506注射液 · No verified English nameJXSL2101121 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2021/10/28Import · Class 2.2; 2.4 IVIEW-1201 · No verified English nameJXHL2101225 IVIEW Therapeutics, Inc.; Ai Wei Pharma (Zhuhai) Co., Ltd. romanized
2021/10/28Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2101219 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2021/10/28Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2101218 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2021/10/28New drug · Class 1 GT101注射液 · No verified English nameCXSL2101394 Suzhou Sha Li Bio Technology Co., Ltd. romanized
2021/10/28New drug · Class 1 D-1553片 · No verified English nameCXHL2101617 Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized
2021/10/28New drug · Class 1 D-1553片 · No verified English nameCXHL2101616 Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized
2021/10/27Import · Class 1 BI685509片 · No verified English nameJXHL2101224 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2021/10/27Import · Class 1 BI685509片 · No verified English nameJXHL2101223 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/10/27Import · Class 1 BI685509片 · No verified English nameJXHL2101222 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/10/27Import · Class 2.4 Tucatinib片 · No verified English nameJXHL2101221 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/10/27Import · Class 2.4 Tucatinib片 · No verified English nameJXHL2101220 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/10/27Generic · Class 3 Levofloxacin InjectionCYHS2101934 Jilin Si Huan Pharmaceutical Co., Ltd. romanized
2021/10/27New drug · Class 1.1 和胃解毒胶囊 · No verified English nameCXZL2101031 Changsha Xin Lin Pharmaceutical Co., Ltd. romanized
2021/10/27New drug · Class 1 首克注利单抗注射液 · No verified English nameCXSS2101042 Zhao Ke (Guangzhou) Zhong Liu Drug Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized
2021/10/27New drug · Class 1 AK112注射液 · No verified English nameCXSL2101392 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/10/27New drug · Class 1 AK117注射液 · No verified English nameCXSL2101391 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/10/27New drug · Class 2.2 注射用全氟丙烷人血白蛋白微球 · No verified English nameCXSL2101390 Xiamen Li Zhuo Pharma Co., Ltd. romanized

41 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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