YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 227 drug applications between 9 November 2021 and 15 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 37, covering 28 drug names.

2021/11/09 – 2021/11/15

Period
2021/11/09 to 2021/11/15, 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
227
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

227filings, 37 of them generic

By application type

Application typeFilings
Supplement121
New drug41
Generic37
Import16
Import re-registration8
Unspecified4

By drug type

Drug typeFilings
Chemical drug158
Therapeutic biologic41
TCM23
Prophylactic biologic4
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
1Dexmedetomidine Hydrochloride Injection320
2泊沙康唑注射液 · No verified English name221
3Tacrolimus Capsules212
4Vonoprazan Fumarate Tablets2160
5Pregabalin Capsules2112
6盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212
7Terbutaline Sulfate Injection212
8Sugammadex Sodium Injection216
9Sodium Valproate Oral Solution111
10Lidocaine and Prilocaine Cream1124

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
1Guangxi Ge Hong Tang Fang Lve Pharmaceutical Co., Ltd. romanized980
2Hunan Wei Er Qiang Pharmaceutical Co., Ltd. romanized640
3Hunan De Kang Pharmaceutical Co., Ltd. romanized550
4Guangdong Da Zhong Pharmaceutical Co., Ltd. romanized520
5Bristol-Myers Squibb Company430
6Pfizer Inc.430
7Eli Lilly Nederland B.V.410
8Sanofi-aventis groupe410
9Takeda Manufacturing Austria AG410
10Shenzhen Wei Xin Bio Technology 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

62 this week

AcceptedDrugApplicants
2021/11/15Import · Class 1 Ritlecitinib胶囊 · No verified English nameJXHL2101244 Pfizer Inc.; Pfizer Investment CO. Ltd.
2021/11/15Import · Class 1 Ritlecitinib胶囊 · No verified English nameJXHL2101243 Pfizer Inc.; Pfizer Investment CO. Ltd.
2021/11/15Generic · Class 3 Thioctic Acid InjectionCYHS2102018 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2021/11/15New drug · Class 1.1 QA108颗粒 · No verified English nameCXZL2101033 Zhuhai Qi Wei Bio Technology Co., Ltd. romanized
2021/11/15New drug · Class 1 WJ01075片 · No verified English nameCXHL2101656 Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/15New drug · Class 1 WJ01075片 · No verified English nameCXHL2101655 Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/12Import · Class 1 BIIB059 · No verified English nameJXSL2101127 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2021/11/12New drug · Class 3.4 人凝血酶原复合物 · No verified English nameCXSS2101051 Hua Lan Bio Gong Cheng Chongqing Co., Ltd. romanized
2021/11/12New drug · Class 3.4 人凝血酶原复合物 · No verified English nameCXSS2101050 Hua Lan Bio Gong Cheng Chongqing Co., Ltd. romanized
2021/11/12New drug · Class 1 PM8002注射液 · No verified English nameCXSL2101423 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2021/11/12New drug · Class 1 注射用IAE0972 · No verified English nameCXSL2101415 Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized
2021/11/12New drug · Class 2.2 艾司奥美拉唑镁碳酸氢钠胶囊 · No verified English nameCXHS2101051 Xiamen En Cheng Pharmaceutical Co., Ltd. romanized
2021/11/12New drug · Class 1 HLX208片 · No verified English nameCXHL2101654 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2021/11/12New drug · Class 1 WXSH0057片 · No verified English nameCXHL2101653 Zhejiang Long Chuan Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/12New drug · Class 1 WXSH0057片 · No verified English nameCXHL2101652 Zhejiang Long Chuan Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/12New drug · Class 2.2 布立西坦缓释片 · No verified English nameCXHL2101651 Shanghai Bo Zhi Yan Xin Drug Technology Co., Ltd. romanized
2021/11/12New drug · Class 1 BPI-371153胶囊 · No verified English nameCXHL2101650 Bei Da Pharma Co., Ltd. romanized
2021/11/12New drug · Class 1 BPI-371153胶囊 · No verified English nameCXHL2101649 Bei Da Pharma Co., Ltd. romanized
2021/11/12New drug · Class 1 HS-10382片 · No verified English nameCXHL2101648 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/12New drug · Class 1 HS-10382片 · No verified English nameCXHL2101647 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/12New drug · Class 1 HS-10382片 · No verified English nameCXHL2101646 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/11Import · Class 1 SAR444245注射液 · No verified English nameJXSL2101126 Sanofi-aventis recherche & développement; Sanofi (China) Investment Co. Ltd.
2021/11/11Import · Class 1 Gepotidacin片 · No verified English nameJXHL2101241 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. Limited
2021/11/11Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2102009 Topfond Pharmaceutical Co., Ltd.
2021/11/11Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2102006 Hangzhou Minsheng Pharmaceutical Co., Ltd
2021/11/11Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2102005 Hangzhou Minsheng Pharmaceutical Co., Ltd
2021/11/11New drug · Class 1.1 白热斯丸 · No verified English nameCXZL2101032 Xinjiang Wei Wu Er Zi Zhi Qu Wei Wu Er Pharmaceuticals Research Institute romanized
2021/11/11New drug · Class 1 GR1803注射液 · No verified English nameCXSL2101420 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized; Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2021/11/11New drug · Class 1 STI-6129注射液 · No verified English nameCXSL2101419 Zhejiang Ai Sen Pharma Co., Ltd. romanized
2021/11/11New drug · Class 1 AK112注射液 · No verified English nameCXSL2101417 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized

32 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.