YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 207 drug applications between 22 March 2022 and 28 March 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 24, covering 20 drug names.

2022/03/22 – 2022/03/28

Period
2022/03/22 to 2022/03/28, 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
207
Drugs with new generic filings (by drug name, de-duplicated)
20
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

207filings, 24 of them generic

By application type

Application typeFilings
Supplement107
New drug41
Generic24
Import22
Import re-registration8
Unspecified5

By drug type

Drug typeFilings
Chemical drug143
Therapeutic biologic38
TCM22
Biologic2
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

20 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Riociguat Tablets314
2Calcium Gluconate Injection215
3重酒石酸卡巴拉汀胶囊 · No verified English name214
4Lidocaine and Prilocaine Cream1124
5Digoxin Injection113
6Doxofylline Injection115
7Levofloxacin Tablets117
8Peramivir Injection117
9Pregabalin Capsules1112
10氧(液态) · No verified English name112

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

121 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized980
2Qilu Pharmaceutical Co., Ltd.953
3AstraZeneca AB630
4Yi Chang Ren Fu Pharma Co., Ltd. romanized531
5Janssen Research & Development LLC440
6Hao Yi Sheng Pharma Group Co., Ltd. romanized440
7Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized410
8Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized410
9Henan Run Hong Pharmaceutical Co., Ltd. romanized330
10Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized330

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

64 this week

AcceptedDrugApplicants
2022/03/28Import · Class 1 Marstacimab注射液 · No verified English nameJXSL2200041 Pfizer Inc.; Pfizer Investment Co. Ltd.
2022/03/28Generic · Class 3 Digoxin InjectionCYHS2200483 Chengdu Hui De Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2022/03/28New drug · Class 1 注射用HBM7008 · No verified English nameCXSL2200148 He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized
2022/03/28New drug · Class 1 重组人血小板源生长因子凝胶 · No verified English nameCXSL2200147 Name not romanized
2022/03/28New drug · Class 1 EXG001-307注射液 · No verified English nameCXSL2200146 Hangzhou Jia Yin Bio Technology Co., Ltd. romanized
2022/03/28New drug · Class 3.2 注射用重组替度鲁肽 · No verified English nameCXSL2200130 Chongqing Pai Jin Bio Technology Co., Ltd. romanized
2022/03/28New drug · Class 1 JS116胶囊 · No verified English nameCXHL2200195 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2022/03/28New drug · Class 1 JDB383片 · No verified English nameCXHL2200194 Shanghai Jia Bao Yao Yin Pharmaceuticals Technology Co., Ltd. romanized
2022/03/28New drug · Class 1 JDB383片 · No verified English nameCXHL2200193 Shanghai Jia Bao Yao Yin Pharmaceuticals Technology Co., Ltd. romanized
2022/03/28New drug · Class 2.2 MTS004 口崩片 · No verified English nameCXHL2200192 Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized
2022/03/25Import · Class 1 AZD8205 · No verified English nameJXSL2200040 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/03/25Import · Class 1 KBP-5074片 · No verified English nameJXHL2200071 KBP BioSciences PTE. Ltd.; KBP Biosciences Co. Ltd.
2022/03/25Import · Class 1 KBP-5074片 · No verified English nameJXHL2200070 KBP Biosciences PTE. Ltd.; KBP Biosciences Co. Ltd.
2022/03/25Import · Class 2.4 阿贝西利片 · No verified English nameJXHL2200066 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/03/25Import · Class 1 Imlunestrant 片 · No verified English nameJXHL2200065 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/03/25New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2200145 Guizhou Zhong Guan Bio Technology Co., Ltd. romanized
2022/03/25New drug · Class 1 LD002注射液 · No verified English nameCXSL2200144 Zhejiang Lan Dun Pharma Co., Ltd. romanized
2022/03/25New drug · Class 2.4 单唾液酸四己糖神经节苷脂钠注射液 · No verified English nameCXHL2200188 Qilu Pharmaceutical Co., Ltd.
2022/03/25New drug · Class 2.4 单唾液酸四己糖神经节苷脂钠注射液 · No verified English nameCXHL2200187 Qilu Pharmaceutical Co., Ltd.
2022/03/25New drug · Class 2.2 丁苯酞注射液 · No verified English nameCXHL2200186 Hebei Sai Pu Rui Si Pharmaceuticals Technology Co., Ltd. romanized
2022/03/25New drug · Class 2.4 康替唑胺片 · No verified English nameCXHL2200185 Shanghai Meng Ke Pharma Co., Ltd. romanized
2022/03/25New drug · Class 1 西奥罗尼胶囊 · No verified English nameCXHL2200169 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
2022/03/25New drug · Class 1 西奥罗尼胶囊 · No verified English nameCXHL2200168 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
2022/03/24Import · Class 1 Olvi-Vec注射液 · No verified English nameJXSL2200039 Genelux Corporation; Newsoara Biopharma Co. Ltd.
2022/03/24Import · Class 2.2 Faricimab注射液 · No verified English nameJXSL2200038 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/03/24Import · Class 1 Linzagolix片 · No verified English nameJXHL2200069 Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd.
2022/03/24Import · Class 1 Linzagolix片 · No verified English nameJXHL2200068 Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd.
2022/03/24Import · Class 1 Linzagolix片 · No verified English nameJXHL2200067 Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd.
2022/03/24New drug · Class 3.4 马破伤风免疫球蛋白F(ab′)2 · No verified English nameCXSS2200031 Yu Xi Jiu Zhou Bio Technology Co., Ltd. romanized
2022/03/24New drug · Class 1 注射用LM-108 · No verified English nameCXSL2200143 Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized

34 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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