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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 219 drug applications between 20 March 2022 and 26 March 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 27, covering 21 drug names.

2022/03/20 – 2022/03/26

Period
2022/03/20 to 2022/03/26, 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
219
Drugs with new generic filings (by drug name, de-duplicated)
21
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

219filings, 27 of them generic

By application type

Application typeFilings
Supplement118
New drug39
Generic27
Import20
Unspecified8
Import re-registration7

By drug type

Drug typeFilings
Chemical drug147
Therapeutic biologic42
TCM24
Prophylactic biologic4
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

21 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Riociguat Tablets314
2Dapoxetine Hydrochloride Tablets2120
3Exenatide Injection210
4Calcium Gluconate Injection215
5重酒石酸卡巴拉汀胶囊 · No verified English name214
6二硫化硒洗剂 · No verified English name1114
7Lidocaine and Prilocaine Cream1124
8Levofloxacin Tablets117
9Peramivir Injection117
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

123 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
4CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD510
5Janssen Research & Development LLC440
6Beijing Rui Ye Pharmaceutical Co., Ltd. romanized420
7Yi Chang Ren Fu Pharma Co., Ltd. romanized421
8Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized410
9Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized410
10Changchun Jin Sai Pharma 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
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
2022/03/24New drug · Class 1 ELPIS人脐带间充质干细胞注射液 · No verified English nameCXSL2200142 Hua Xia Yuan (Shanghai) Bio Technology Co., Ltd. romanized
2022/03/24New drug · Class 1 抗CD19/CD20嵌合抗原受体自体T细胞注射液 · No verified English nameCXSL2200141 Shanghai Sai Bi Man Bio Technology Co., Ltd. romanized
2022/03/24New drug · Class 2.2 小儿水合氯醛糖浆 · No verified English nameCXHS2200017 Hainan Peng Kang Pharma Co., Ltd. romanized; Hainan Sen Qi Pharmaceutical Co., Ltd. romanized
2022/03/24New drug · Class 1 MN-08眼用凝胶 · No verified English nameCXHL2200184 Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized
2022/03/24New drug · Class 1 MN-08眼用凝胶 · No verified English nameCXHL2200183 Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized
2022/03/24New drug · Class 1 MN-08眼用凝胶 · No verified English nameCXHL2200182 Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized
2022/03/24New drug · Class 1 MN-08眼用凝胶 · No verified English nameCXHL2200181 Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized
2022/03/24New drug · Class 2.3 Y-6舌下片 · No verified English nameCXHL2200178 Nanjing Ning Dan Xin Yao Technology Co., Ltd. romanized
2022/03/23New drug · Class 1 AK104注射液 · No verified English nameCXSL2200140 Kang Fang Pharma Co., Ltd. romanized
2022/03/23New drug · Class 1 RP903片 · No verified English nameCXHL2200180 Jun Shi Run Jia (Shanghai) Pharmaceuticals Technology 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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