YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 175 drug applications between 29 September 2021 and 5 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 33, covering 23 drug names.

2021/09/29 – 2021/10/05

Period
2021/09/29 to 2021/10/05, 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
175
Drugs with new generic filings (by drug name, de-duplicated)
23
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

175filings, 33 of them generic

By application type

Application typeFilings
Supplement78
New drug34
Generic33
Import14
Import re-registration9
Unspecified7

By drug type

Drug typeFilings
Chemical drug141
TCM18
Therapeutic biologic15
Prophylactic 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

23 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lacosamide Oral Solution220
2Voriconazole for Injection225
3Linezolid and Glucose Injection213
4Topiroxostat Tablets210
5Torsemide Injection211
6Lacosamide Tablets210
7Losartan Potassium Tablets215
8Nicorandil for Injection211
9Dopamine Hydrochloride Injection213
10Butorphanol Tartrate Injection210

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

106 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized620
2Shenzhen Ke Xing Pharma Co., Ltd. romanized610
3Jiangsu Hao Sen Pharma Group Co., Ltd. romanized530
4Bayer AG510
5Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized430
6Hubei Min Kang Pharmaceutical Co., Ltd. romanized420
7Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized410
8Jiangxi Di Kang Pharma Co., Ltd. romanized330
9Hebei Wu Luo Pharma Co., Ltd. romanized330
10Shanghai Qiang Sheng Pharmaceutical Co., Ltd. romanized320

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

60 this week

AcceptedDrugApplicants
2021/09/30Import · Class 3.1 甘精胰岛素利司那肽注射液2:1 · No verified English nameJXSS2101025 Sanofi-Aventis Groupe; Sanofi-Aventis Deutschland GmbH; Sanofi (China) Investment Co. Ltd.
2021/09/30New drug · Class 1 盐酸柯诺拉赞片 · No verified English nameCXHS2101047 Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized; Nanjing Ke Fei Ping Sheng Hui Pharmaceutical Co., Ltd. romanized
2021/09/30New drug · Class 1 盐酸柯诺拉赞片 · No verified English nameCXHS2101046 Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized; Nanjing Ke Fei Ping Sheng Hui Pharmaceutical Co., Ltd. romanized
2021/09/30New drug · Class 1 培化西海马肽注射液 · No verified English nameCXHS2101045 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/09/30New drug · Class 1 培化西海马肽注射液 · No verified English nameCXHS2101044 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/09/30New drug · Class 1 培化西海马肽注射液 · No verified English nameCXHS2101043 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/09/30New drug · Class 1 ZX-101A胶囊 · No verified English nameCXHL2101537 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized
2021/09/30New drug · Class 1 ZX-101A胶囊 · No verified English nameCXHL2101536 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized
2021/09/30New drug · Class 1 ZX-101A胶囊 · No verified English nameCXHL2101535 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized
2021/09/30New drug · Class 1 OB756片 · No verified English nameCXHL2101534 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2021/09/30New drug · Class 1 IPG7236片 · No verified English nameCXHL2101533 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/30New drug · Class 1 IPG7236片 · No verified English nameCXHL2101532 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/30New drug · Class 2.2 注射用盐酸特拉唑嗪 · No verified English nameCXHL2101531 Bang En Tai (Xiamen) Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/30New drug · Class 1 IPG1094片 · No verified English nameCXHL2101521 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/30New drug · Class 1 IPG1094片 · No verified English nameCXHL2101520 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/30New drug · Class 1 SDT-102 片 · No verified English nameCXHL2101517 Suzhou Jin Sheng Pharma Co., Ltd. romanized
2021/09/30New drug · Class 1 SDT-102 片 · No verified English nameCXHL2101516 Suzhou Jin Sheng Pharma Co., Ltd. romanized
2021/09/29Import · Class 3.1 甘精胰岛素利司那肽注射液1:1 · No verified English nameJXSS2101024 Sanofi K. K.; Sanofi-Aventis Deutschland GmbH; Sanofi (China) Investment Co. Ltd.
2021/09/29Import · Class 1 TJ271 注射液 · No verified English nameJXSL2101114 I-MAB Biopharma US Limited; I-MAB Biopharm Co. Ltd
2021/09/29Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2101113 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2021/09/29Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2101112 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2021/09/29Import · Class 1 Paxalisib 胶囊 · No verified English nameJXHL2101194 KAZIA THERAPEUTICS LIMITED; Jiangsu Simcere Pharmaceutical Co. Ltd.
2021/09/29Import · Class 1 ONC201胶囊 · No verified English nameJXHL2101193 Sanjiu Healthy World Company Limited; China Resources Sanjiu Medical&Pharmaceutical Co. Ltd.
2021/09/29Import · Class 1 AM006 · No verified English nameJXHL2101192 Affamed Therapeutics (US) Inc.
2021/09/29Import · Class 1 Avacopan硬胶囊 · No verified English nameJXHL2101190 Vifor Fresenius Medical Care Renal Pharma Ltd.; Hangzhou Tigermed Consulting Co. Ltd.
2021/09/29Import · Class 1 IDX-1197 片 · No verified English nameJXHL2101189 Idience Co. Ltd.; Syneos Health (Beijing)Inc. Ltd.
2021/09/29Import · Class 1 IDX-1197 片 · No verified English nameJXHL2101188 Idience Co. Ltd.; Syneos Health (Beijing)Inc. Ltd.
2021/09/29Import · Class 1 IDX-1197 片 · No verified English nameJXHL2101187 Idience Co. Ltd.; Syneos Health (Beijing)Inc. Ltd.
2021/09/29Generic · Class 3 Torsemide InjectionCYHS2101800 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2021/09/29Generic · Class 3 Torsemide InjectionCYHS2101799 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized

30 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.