YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 306 drug applications between 23 September 2021 and 29 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 36 drug names.

2021/09/23 – 2021/09/29

Period
2021/09/23 to 2021/09/29, 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
306
Drugs with new generic filings (by drug name, de-duplicated)
36
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

306filings, 53 of them generic

By application type

Application typeFilings
Supplement158
Generic53
New drug48
Import21
Import re-registration15
Unspecified11

By drug type

Drug typeFilings
Chemical drug232
Therapeutic biologic41
TCM27
Biologic4
Prophylactic biologic2

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

36 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dopamine Hydrochloride Injection433
2Clindamycin Injection314
3Esomeprazole Magnesium for Delayed-release Oral Suspension314
4Lacosamide Oral Solution220
5Bromfenac Sodium Eye Drops227
6Linezolid and Glucose Injection213
7Ibuprofen Suspension2114
8Topiroxostat Tablets210
9Torsemide Injection211
10Lacosamide Tablets210

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

163 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized19100
2Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized1010
3Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized810
4Hubei Ye Zhen Tang Pharma Co., Ltd. romanized770
5Kyowa Kirin Co. Ltd610
6Shenzhen Ke Xing Pharma Co., Ltd. romanized610
7Jiangxi Di Kang Pharma Co., Ltd. romanized550
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized520
9Bayer AG510
10Bristol-Myers Squibb Pharma EEIG510

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

89 this week

AcceptedDrugApplicants
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
2021/09/29Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2101796 Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized
2021/09/29Generic · Class 3 Venlafaxine Hydrochloride Extended Release TabletsCYHS2101794 Hefei Li Fang Pharmaceutical Co., Ltd. romanized
2021/09/29Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2101793 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2021/09/29Generic · Class 3 Nicorandil for InjectionCYHS2101792 Tianjin Tian Shi Li Zhi Jiao Pharma Co., Ltd. romanized
2021/09/29Generic · Class 3 Nicorandil for InjectionCYHS2101791 Tianjin Tian Shi Li Zhi Jiao Pharma Co., Ltd. romanized
2021/09/29Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2101790 Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized
2021/09/29Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2101789 Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized
2021/09/29Generic · Class 3 Butorphanol Tartrate InjectionCYHS2101774 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2021/09/29Generic · Class 3 Butorphanol Tartrate InjectionCYHS2101773 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2021/09/29Generic · Class 3 Vasopressin InjectionCYHL2101029 Chengdu Guo Wei Biopharmaceuticals Co., Ltd. romanized
2021/09/29Generic · Class 3 Topiroxostat TabletsCYHL2101028 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized
2021/09/29Generic · Class 3 Topiroxostat TabletsCYHL2101027 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized
2021/09/29New drug · Class 1 镓[68Ga]纳坦重组PD-L1单域抗体注射液 · No verified English nameCXSL2101344 Suzhou Zhi He Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/29New drug · Class 2.2 盐酸右美托咪定鼻喷剂 · No verified English nameCXHS2101042 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/09/29New drug · Class 1 注射用BGC0228 · No verified English nameCXHL2101529 Bo Rui Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2021/09/29New drug · Class 2.2 布立西坦缓释片 · No verified English nameCXHL2101527 Tai Zhou Yue Yang Pharmaceuticals Kai Fa Co., Ltd. romanized
2021/09/29New drug · Class 1 ETH-155008片 · No verified English nameCXHL2101526 Cheng Ke Pharma (Jiangsu) Co., Ltd. romanized

59 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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