YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 325 drug applications between 14 October 2021 and 20 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 28 drug names.

2021/10/14 – 2021/10/20

Period
2021/10/14 to 2021/10/20, 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
325
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

325filings, 44 of them generic

By application type

Application typeFilings
Supplement199
New drug51
Generic44
Import11
Unspecified10
Import re-registration10

By drug type

Drug typeFilings
Chemical drug183
TCM91
Therapeutic biologic42
Biologic7
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

28 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1阿普米司特片 · No verified English name623
2Fluconazole for Oral Suspension410
3Sitagliptin Phosphate Tablets312
4Dimethyl Fumarate Delayed-release Capsules210
5Empagliflozin Tablets2118
6Fluconazole and Sodium Chloride Injection211
7Meropenem for Injection215
8Nitroglycerin Injection217
9Esomeprazole Magnesium Enteric-Coated Capsules214
10Desonide Cream110

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

149 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Wan Hui Pharmaceutical Co., Ltd. romanized71530
2Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized23110
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized1160
4Fo Shan De Rui Ke Pharmaceutical Co., Ltd. romanized510
5Bioverativ Therapeutics Inc410
6NAPP PHARMACEUTICALS LIMITED410
7Takeda Pharmaceutical Company Limited410
8Zhejiang Pu Li Pharma Co., Ltd. romanized414
9Changchun Jin Sai Pharma Co., Ltd. romanized410
10Novo Nordisk A/S330

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

74 this week

AcceptedDrugApplicants
2021/10/20New drug · Class 1 注射用RS2102 · No verified English nameCXSL2101376 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2021/10/19Import · Class 3.1 替拉珠单抗注射液 · No verified English nameJXSS2101026 Sun Pharma Global FZE; Vetter Pharma-Fertigung GmbH & Co. KG; Shenzhen Kangzhe Biotechnology Co. Ltd.
2021/10/19Import · Class 1 SAR442168 · No verified English nameJXHL2101209 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2021/10/19Import · Class 2.4 Lorlatinib片 · No verified English nameJXHL2101208 Pfizer Inc.; Cstone Pharmaceuticals (Suzhou) Co. Ltd.
2021/10/19Import · Class 1 VIC-1911片 · No verified English nameJXHL2101207 JS INNOPHARM LIMITED; JS InnoPharm (Suzhou) Ltd.
2021/10/19Import · Class 1 VIC-1911片 · No verified English nameJXHL2101206 JS INNOPHARM LIMITED; JS InnoPharm (Suzhou) Ltd.
2021/10/19Import · Class 1 BAY 2927088溶液 · No verified English nameJXHL2101202 Bayer AG; Bayer Healthcare Company Ltd.
2021/10/19Generic · Class 3 Fluconazole for Oral SuspensionCYHS2101895 Zhejiang Pu Li Pharma Co., Ltd. romanized
2021/10/19Generic · Class 3 Fluconazole for Oral SuspensionCYHS2101894 Zhejiang Pu Li Pharma Co., Ltd. romanized
2021/10/19Generic · Class 3 Fluconazole for Oral SuspensionCYHS2101893 Zhejiang Pu Li Pharma Co., Ltd. romanized
2021/10/19Generic · Class 3 Fluconazole for Oral SuspensionCYHS2101892 Zhejiang Pu Li Pharma Co., Ltd. romanized
2021/10/19Generic · Class 3 Nitroglycerin InjectionCYHS2101891 Hui Ke De Cheng (Guangdong) Yi Xue Technology Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2021/10/19Generic · Class 3 Nitroglycerin InjectionCYHS2101888 Hui Ke De Cheng (Guangdong) Yi Xue Technology Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2021/10/19Generic · Class 3 Terbutaline Sulfate InjectionCYHS2101884 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2021/10/19New drug · Class 3.2 重组人生长激素注射液 · No verified English nameCXSS2101039 Changchun Jin Sai Pharma Co., Ltd. romanized
2021/10/19New drug · Class 3.2 重组人生长激素注射液 · No verified English nameCXSS2101038 Changchun Jin Sai Pharma Co., Ltd. romanized
2021/10/19New drug · Class 3.2 重组人生长激素注射液 · No verified English nameCXSS2101037 Changchun Jin Sai Pharma Co., Ltd. romanized
2021/10/19New drug · Class 3.2 重组人生长激素注射液 · No verified English nameCXSS2101036 Changchun Jin Sai Pharma Co., Ltd. romanized
2021/10/19New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101372 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/10/19New drug · Class 3.3 13价肺炎球菌结合疫苗 · No verified English nameCXSL2101371 Suzhou Wei Chao Bio Technology Co., Ltd. romanized
2021/10/19New drug · Class 1 重组人Ⅱ型肿瘤坏死因子受体-Fc-血小板生成素拟肽融合蛋白注射液 · No verified English nameCXSL2101370 Sichuan San Ye Cao Biopharmaceutical Co., Ltd. romanized
2021/10/19New drug · Class 1 自体记忆性淋巴细胞注射液 · No verified English nameCXSL2101360 Nuo Wei Technology (Beijing) Co., Ltd. romanized
2021/10/19New drug · Class 3.3 美泊利单抗注射液 · No verified English nameCXSL2101358 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2021/10/19New drug · Class 1 YY-20394片 · No verified English nameCXHL2101580 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/10/19New drug · Class 1 Hemay005片 · No verified English nameCXHL2101579 Gan Zhou He Mei Pharma Co., Ltd. romanized
2021/10/19New drug · Class 2.4 Apatinib Mesylate TabletsCXHL2101578 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/10/19New drug · Class 2.4 Apatinib Mesylate TabletsCXHL2101577 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/10/19New drug · Class 2.4 Apatinib Mesylate TabletsCXHL2101576 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/10/19New drug · Class 1 德立替尼胶囊 · No verified English nameCXHL2101575 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized
2021/10/19New drug · Class 1 德立替尼胶囊 · No verified English nameCXHL2101574 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized

44 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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