YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 166 drug applications between 17 March 2021 and 23 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 17, covering 11 drug names.

2021/03/17 – 2021/03/23

Period
2021/03/17 to 2021/03/23, 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
166
Drugs with new generic filings (by drug name, de-duplicated)
11
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

166filings, 17 of them generic

By application type

Application typeFilings
Supplement90
Import24
New drug23
Generic17
Unspecified7
Import re-registration5

By drug type

Drug typeFilings
Chemical drug134
Therapeutic biologic25
TCM2
Biologic2
Prophylactic biologic2
In vitro diagnostic reagent1

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

11 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sodium Valproate Concentrated Solution for Injection310
2Argatroban Injection222
3Saxagliptin Tablets210
4Pemetrexed Disodium for Injection214
5Febuxostat Tablets2112
6头孢地尼颗粒 · No verified English name113
7Lormetazepam Injection110
8Palonosetron Hydrochloride Injection111
9Venlafaxine Hydrochloride Sustained-Release Capsules110
10Lanthanum Carbonate Chewable Tablets112

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

87 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Si Huan Biopharmaceutical Co., Ltd. romanized1010
2Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized840
3Astrazeneca UK Limited610
4Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized523
5LABORATORIOS FARMACEUTICOS ROVI S.A.510
6AstraZeneca UK Limited410
7Loxo Oncology Inc.410
8Mirum Pharmaceuticals Inc.410
9Shenzhen Ming Sai Rui Lin Pharma Co., Ltd. romanized410
10Novartis Pharma Schweiz AG320

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

40 this week

AcceptedDrugApplicants
2021/03/23Import · Class 1 注射用LNA043 · No verified English nameJXSL2100043 Novartis Pharma AG
2021/03/23Generic · Class 3 头孢地尼颗粒 · No verified English nameCYHS2100289 Hefei En Rui Te Pharma Co., Ltd. romanized; Anhui An Ke Heng Yi Pharma Co., Ltd. romanized
2021/03/23New drug · Class 3.3 重组人GLP-1-Fc融合蛋白注射液 · No verified English nameCXSL2100102 Hua Run Ang De Bio Pharma Co., Ltd. romanized
2021/03/23New drug · Class 3.3 重组人GLP-1-Fc融合蛋白注射液 · No verified English nameCXSL2100101 Hua Run Ang De Bio Pharma Co., Ltd. romanized
2021/03/23New drug · Class 1 西格列他钠片 · No verified English nameCXHL2101009 Chengdu Wei Xin Pharma Co., Ltd. romanized
2021/03/23New drug · Class 1 希列克托灵片 · No verified English nameCXHL2100197 Shenzhen Ming Sai Rui Lin Pharma Co., Ltd. romanized
2021/03/23New drug · Class 1 希列克托灵片 · No verified English nameCXHL2100196 Shenzhen Ming Sai Rui Lin Pharma Co., Ltd. romanized
2021/03/23New drug · Class 1 希列克托灵片 · No verified English nameCXHL2100195 Shenzhen Ming Sai Rui Lin Pharma Co., Ltd. romanized
2021/03/23New drug · Class 1 希列克托灵片 · No verified English nameCXHL2100194 Shenzhen Ming Sai Rui Lin Pharma Co., Ltd. romanized
2021/03/23New drug · Class 1 SYHX1903片 · No verified English nameCXHL2100193 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2021/03/23New drug · Class 1 SYHX1903片 · No verified English nameCXHL2100192 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2021/03/23New drug · Class 2.2; 2.4 乙酸避孕凝胶 · No verified English nameCXHL2100191 Shanghai Shi Ji Hua Sheng Yu Ke Xue Research Institute romanized
2021/03/23New drug · Class 1 PA9159鼻喷雾剂 · No verified English nameCXHL2100187 Anhui Bai La A Tu Pharmaceuticals Technology Co., Ltd. romanized
2021/03/23New drug · Class 1 PA9159鼻喷雾剂 · No verified English nameCXHL2100186 Anhui Bai La A Tu Pharmaceuticals Technology Co., Ltd. romanized
2021/03/22New drug · Class 1 IBI302 · No verified English nameCXSL2101006 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/03/20Import · Class 1 Maralixibat口服溶液 · No verified English nameJXHL2100100 Mirum Pharmaceuticals Inc.
2021/03/20Import · Class 1 Maralixibat口服溶液 · No verified English nameJXHL2100099 Mirum Pharmaceuticals Inc.
2021/03/20Import · Class 1 Maralixibat口服溶液 · No verified English nameJXHL2100098 Mirum Pharmaceuticals Inc.
2021/03/20Import · Class 1 Maralixibat口服溶液 · No verified English nameJXHL2100097 Mirum Pharmaceuticals Inc.
2021/03/20Import · Class 1 Atrasentan片 · No verified English nameJXHL2100096 Chinook Therapeutics U.S. Inc.
2021/03/20Import · Class 1 LOXO-305 · No verified English nameJXHL2100093 Loxo Oncology Inc.
2021/03/20Import · Class 1 LOXO-305 · No verified English nameJXHL2100092 Loxo Oncology Inc.
2021/03/20Import · Class 1 LOXO-305 · No verified English nameJXHL2100091 Loxo Oncology Inc.
2021/03/20Import · Class 1 LOXO-305 · No verified English nameJXHL2100090 Loxo Oncology Inc.
2021/03/20Import · Class 2.4 Lenvatinib Mesilate CapsulesJXHL2100089 Eisai Europe Ltd.
2021/03/20Import · Class 2.4 Lenvatinib Mesilate CapsulesJXHL2100088 Eisai Europe Ltd.
2021/03/20New drug · Class 1 阿基仑赛注射液 · No verified English nameCXSL2100098 Fu Xing Kai Te Bio Technology Co., Ltd. romanized
2021/03/19New drug · Class 2.4 Tenofovir alafenamide Fumarate TabletsCXHS2100010 Hua Bei Pharmaceutical Hua Kun Hebei Bio Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2021/03/19New drug · Class 1 ASC42片 · No verified English nameCXHL2101008 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized
2021/03/19New drug · Class 1 ASC42片 · No verified English nameCXHL2101007 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized

10 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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