YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 263 drug applications between 22 October 2021 and 28 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 34, covering 26 drug names.

2021/10/22 – 2021/10/28

Period
2021/10/22 to 2021/10/28, 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
263
Drugs with new generic filings (by drug name, de-duplicated)
26
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

263filings, 34 of them generic

By application type

Application typeFilings
Supplement134
New drug47
Generic34
Import25
Import re-registration17
Unspecified6

By drug type

Drug typeFilings
Chemical drug181
TCM38
Therapeutic biologic37
Prophylactic biologic4
Biologic3

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

26 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
10Furosemide Injection116

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

149 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Gansu Fu Ge Zang Yao Co., Ltd. romanized21190
2AstraZeneca AB530
3Hainan Jiu Chang Pharmaceutical Co., Ltd. romanized530
4Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized520
5Sanofi-Aventis Groupe510
6Boehringer Ingelheim International GmbH420
7Shanghai Jia Bao Yao Yin Pharmaceuticals Technology Co., Ltd. romanized420
8Shandong An Xin Pharmaceutical Co., Ltd. romanized420
9Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized420
10Changchun Jin Sai Pharma Co., Ltd. romanized420

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

77 this week

AcceptedDrugApplicants
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
2021/10/27New drug · Class 2.4 泽布替尼胶囊 · No verified English nameCXHL2101615 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2021/10/27New drug · Class 1 SYHX2001片 · No verified English nameCXHL2101614 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2021/10/27New drug · Class 1 SYHX2001片 · No verified English nameCXHL2101613 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2021/10/27New drug · Class 1 NIP001片 · No verified English nameCXHL2101610 Zhongguo Pharmaceuticals Research Kai Fa Center Co., Ltd. romanized
2021/10/27New drug · Class 1 NIP001片 · No verified English nameCXHL2101609 Zhongguo Pharmaceuticals Research Kai Fa Center Co., Ltd. romanized
2021/10/26Import · Class 2.2 Emapalumab · No verified English nameJXSL2101120 Swedish Orphan Biovitrum AG; Sobi Pharma(Guangzhou)Co. Limited
2021/10/26Import · Class 2.4 度维利塞胶囊 · No verified English nameJXHL2101214 Secura Bio Inc.; CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY (SJZ) CO. LTD.
2021/10/26Import · Class 2.4 度维利塞胶囊 · No verified English nameJXHL2101213 Secura Bio Inc.; CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY (SJZ) CO. LTD.
2021/10/26Import · Class 2.4 紫杉醇口服溶液 · No verified English nameJXHL2101205 DAEHWA PHARMACEUTICAL CO. LTD; Shanghai RMX Biopharma Co. Ltd
2021/10/26Import · Class 2.4 紫杉醇口服溶液 · No verified English nameJXHL2101204 DAEHWA PHARMACEUTICAL CO. LTD; Shanghai RMX Biopharma Co. Ltd
2021/10/26Import · Class 2.4 紫杉醇口服溶液 · No verified English nameJXHL2101203 DAEHWA PHARMACEUTICAL CO. LTD; Shanghai RMX Biopharma Co. Ltd
2021/10/26Generic · Class 3 Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2101924 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized

47 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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