YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 230 drug applications between 10 November 2021 and 16 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 40, covering 27 drug names.

2021/11/10 – 2021/11/16

Period
2021/11/10 to 2021/11/16, 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
230
Drugs with new generic filings (by drug name, de-duplicated)
27
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

230filings, 40 of them generic

By application type

Application typeFilings
Supplement117
New drug44
Generic40
Import re-registration14
Import9
Unspecified6

By drug type

Drug typeFilings
Chemical drug167
Therapeutic biologic32
TCM26
Biologic3
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

27 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dexmedetomidine Hydrochloride Injection320
2Sodium Valproate Concentrated Solution for Injection210
3Tacrolimus Capsules212
4Ozagrel Sodium Injection213
5Obeticholic Acid Tablets210
6Vonoprazan Fumarate Tablets2160
7Bisoprolol Fumarate Tablets216
8Pregabalin Capsules2112
9Cytarabine for Injection212
10盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212

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

140 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
3Upjohn Manufacturing Ireland Unlimited610
4Da Lian Tian Shan Pharma Co., Ltd. romanized550
5Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized420
6Fujian Sheng Fu Kang Pharma Co., Ltd. romanized420
7Sanofi-aventis groupe410
8Takeda Manufacturing Austria AG410
9Upjohn US 2 LLC410
10Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized410

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

66 this week

AcceptedDrugApplicants
2021/11/16Import · Class 2.2 奥妥珠单抗注射液 · No verified English nameJXSL2101130 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2021/11/16Generic · Class 3 Ozagrel Sodium InjectionCYHS2102031 Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2021/11/16Generic · Class 3 Ozagrel Sodium InjectionCYHS2102030 Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2021/11/16Generic · Class 3 Pentoxifylline InjectionCYHS2102029 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2021/11/16Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2102025 Ji Chuan Pharma Group Co., Ltd. romanized
2021/11/16Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2102024 Ji Chuan Pharma Group Co., Ltd. romanized
2021/11/16Generic · Class 3 Obeticholic Acid TabletsCYHL2101040 Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized
2021/11/16Generic · Class 3 Obeticholic Acid TabletsCYHL2101039 Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized
2021/11/16New drug · Class 1 AK104注射液 · No verified English nameCXSL2101425 Kang Fang Pharma Co., Ltd. romanized
2021/11/16New drug · Class 1 注射用DR30303 · No verified English nameCXSL2101424 Zhejiang Dao Er Bio Technology Co., Ltd. romanized
2021/11/16New drug · Class 1 ASK120067片 · No verified English nameCXHS2101052 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2021/11/16New drug · Class 1 BIOS-0618片 · No verified English nameCXHL2101665 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2021/11/16New drug · Class 1 BIOS-0618片 · No verified English nameCXHL2101664 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2021/11/16New drug · Class 1 JAB-3312胶囊 · No verified English nameCXHL2101663 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/11/16New drug · Class 1 JAB-3312胶囊 · No verified English nameCXHL2101662 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/11/16New drug · Class 1 JAB-21822片 · No verified English nameCXHL2101661 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/11/16New drug · Class 1 JAB-21822片 · No verified English nameCXHL2101660 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/11/16New drug · Class 1 TSN084片 · No verified English nameCXHL2101659 Tai Li Bio Technology (Shanghai) Co., Ltd. romanized
2021/11/16New drug · Class 1 TSN084片 · No verified English nameCXHL2101658 Tai Li Bio Technology (Shanghai) Co., Ltd. romanized
2021/11/16New drug · Class 1 TSN084片 · No verified English nameCXHL2101657 Tai Li Bio Technology (Shanghai) Co., Ltd. romanized
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

36 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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