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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 173 drug applications between 1 April 2021 and 7 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 16, covering 11 drug names.

2021/04/01 – 2021/04/07

Period
2021/04/01 to 2021/04/07, 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
173
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

173filings, 16 of them generic

By application type

Application typeFilings
Supplement92
New drug28
Import24
Generic16
Unspecified7
Import re-registration6

By drug type

Drug typeFilings
Chemical drug124
Therapeutic biologic36
TCM9
Prophylactic biologic4

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
1头孢羟氨苄干混悬剂 · No verified English name212
2Olanzapine Tablets214
3Dapagliflozin Tablets2184
4Metoprolol Tartrate Tablets213
5Ranolazine Prolonged-Release Tablets213
6Ibrutinib Capsules119
7Rivaroxaban Tablets113
8Mycophenolate Mofetil Capsules114
9Torsemide Injection111
10Glycopyrronium Bromide and Neostigmine Metilsulfate Injection113

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

107 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Janssen-Cilag International NV610
2Bao Ding Jiu Hui Pharmaceuticals Zhi Zao Co., Ltd. romanized550
3Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.520
4Fo Shan De Rui Ke Pharmaceutical Co., Ltd. romanized510
5Janssen Research & Development LLC420
6Sichuan Kelun Pharmaceutical Co., Ltd.410
7Eurofins Analytical Science Laboratories Inc.330
8Pfizer Inc320
9Tong Fang Pharma Group Co., Ltd. romanized320
10Yangtze River Pharmaceutical Group Co., Ltd322

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

55 this week

AcceptedDrugApplicants
2021/04/07Import · Class 3.1 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2101001 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd.
2021/04/07Import · Class 3.1 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2101000 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd.
2021/04/07Import · Class 3.1 贝伐珠单抗注射液 · No verified English nameJXSS2100023 Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH
2021/04/07Import · Class 1 SEA-CD70 · No verified English nameJXSL2101005 BeiGene Ltd.; BeiGene(Beijing) Co. Ltd.
2021/04/07Import · Class 1 PF-06863135 · No verified English nameJXSL2101004 Pfizer Inc; Pfizer Investment CO. Ltd.
2021/04/07Import · Class 2.4 Talazoparib胶囊 · No verified English nameJXHL2101006 Pfizer Inc; Pfizer Investment CO. Ltd.
2021/04/07Import · Class 2.4 Talazoparib胶囊 · No verified English nameJXHL2101005 Pfizer Inc; Pfizer Investment CO. Ltd.
2021/04/07Import · Class 1 MK-5475吸入粉雾剂 · No verified English nameJXHL2101004 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/04/07Import · Class 1 MK-5475吸入粉雾剂 · No verified English nameJXHL2101003 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/04/07Import · Class 1 MK-5475吸入粉雾剂 · No verified English nameJXHL2101002 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/04/07Generic · Class 3 头孢羟氨苄干混悬剂 · No verified English nameCYHS2101038 Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized
2021/04/07Generic · Class 3 头孢羟氨苄干混悬剂 · No verified English nameCYHS2101037 Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized
2021/04/07New drug · Class 2.3 芩香清解口服液 · No verified English nameCXZL2101004 Yi Pin Hong Biopharmaceuticals Co., Ltd. romanized
2021/04/07New drug · Class 1 TWP-102注射液 · No verified English nameCXSL2101011 Shandong Tai Ze Hui Kang Biopharmaceuticals Co., Ltd. romanized
2021/04/07New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101010 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/04/07New drug · Class 1 SYSA1801注射液 · No verified English nameCXSL2101009 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2021/04/07New drug · Class 2.4 奥布替尼片 · No verified English nameCXHL2101025 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/04/07New drug · Class 1 KL590586胶囊 · No verified English nameCXHL2101024 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2021/04/07New drug · Class 1 KL590586胶囊 · No verified English nameCXHL2101023 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2021/04/07New drug · Class 1 FCN-098胶囊 · No verified English nameCXHL2101021 Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized
2021/04/07New drug · Class 1 FCN-098胶囊 · No verified English nameCXHL2101020 Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized
2021/04/07New drug · Class 1 BPI-16350 胶囊 · No verified English nameCXHL2101019 Bei Da Pharma Co., Ltd. romanized
2021/04/07New drug · Class 1 BPI-16350 胶囊 · No verified English nameCXHL2101018 Bei Da Pharma Co., Ltd. romanized
2021/04/07New drug · Class 1 SHR1459片 · No verified English nameCXHL2101017 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2021/04/07New drug · Class 1 CK21脂肪乳注射液 · No verified English nameCXHL2100219 Xin Kai Pharmaceuticals Chemical Zhong Jian Ti (Shanghai) Co., Ltd. romanized
2021/04/03New drug · Class 1.1 六合丹软膏 · No verified English nameCXZL2100003 Sichuan University Hua Xi Hospital romanized
2021/04/03New drug · Class 1 注射用重组人源化抗Muc1单抗-Tub201偶联剂 · No verified English nameCXSL2100114 Hangzhou Duo Xi Bio Technology Co., Ltd. romanized
2021/04/03New drug · Class 3.3 流感病毒裂解疫苗 · No verified English nameCXSL2100113 Shanxi Pei Sen Bio Technology Co., Ltd. romanized
2021/04/03New drug · Class 2.2 阿地溴铵吸入粉雾剂 · No verified English nameCXHL2100218 Health Yuan Pharma Group Co., Ltd. romanized
2021/04/02Import · Class 3.3 注射用英夫利西单抗 · No verified English nameJXSS2100022 CELLTRION Inc.

25 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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