YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 130 drug applications between 2 April 2021 and 8 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 10, covering 8 drug names.

2021/04/02 – 2021/04/08

Period
2021/04/02 to 2021/04/08, 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
130
Drugs with new generic filings (by drug name, de-duplicated)
8
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

130filings, 10 of them generic

By application type

Application typeFilings
Supplement61
New drug30
Import21
Generic10
Unspecified7
Import re-registration1

By drug type

Drug typeFilings
Chemical drug101
Therapeutic biologic21
TCM5
Prophylactic biologic3

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

8 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
3Ibrutinib Capsules119
4Rivaroxaban Tablets113
5Mycophenolate Mofetil Capsules114
6Torsemide Injection111
7Glycopyrronium Bromide and Neostigmine Metilsulfate Injection113
8Vildagliptin Tablets110

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

85 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bao Ding Jiu Hui Pharmaceuticals Zhi Zao Co., Ltd. romanized550
2Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.520
3Fo Shan De Rui Ke Pharmaceutical Co., Ltd. romanized510
4Eurofins Analytical Science Laboratories Inc.330
5Pfizer Inc320
6Loxo Oncology Inc.310
7You Shi Bi (Zhuhai) Pharmaceutical Co., Ltd. romanized310
8Shanxi Kang Bao Bio Zhi Pin Co., Ltd. romanized310
9Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized310
10Hui Rui Pharmaceutical Co., Ltd. romanized310

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

50 this week

AcceptedDrugApplicants
2021/04/08Import · Class 1 注射用Loncastuximab tesirine · No verified English nameJXSL2100051 ADC Therapeutics SA
2021/04/08Import · Class 1 LOXO-305片 · No verified English nameJXHL2100115 Loxo Oncology Inc.
2021/04/08Import · Class 1 LOXO-305片 · No verified English nameJXHL2100114 Loxo Oncology Inc.
2021/04/08Import · Class 1 LOXO-305片 · No verified English nameJXHL2100113 Loxo Oncology Inc.
2021/04/08New drug · Class 1 恩沃利单抗注射液 · No verified English nameCXSL2100116 Sichuan Si Lu Kang Rui Pharma Co., Ltd. romanized
2021/04/08New drug · Class 1 恩沃利单抗注射液 · No verified English nameCXSL2100115 Sichuan Si Lu Kang Rui Pharma Co., Ltd. romanized
2021/04/08New drug · Class 1 XNW1011胶囊 · No verified English nameCXHL2100223 Xing Lian Pharma (Suzhou) Co., Ltd. romanized
2021/04/08New drug · Class 1 XNW1011胶囊 · No verified English nameCXHL2100222 Xing Lian Pharma (Suzhou) Co., Ltd. romanized
2021/04/08New drug · Class 1 QR052107B片 · No verified English nameCXHL2100221 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2021/04/08New drug · Class 1 QR052107B片 · No verified English nameCXHL2100220 Wuhan Lang Lai Technology Development Co., Ltd. romanized
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

20 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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