YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 184 drug applications between 6 April 2021 and 12 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 18, covering 16 drug names.

2021/04/06 – 2021/04/12

Period
2021/04/06 to 2021/04/12, 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
184
Drugs with new generic filings (by drug name, de-duplicated)
16
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

184filings, 18 of them generic

By application type

Application typeFilings
Supplement92
New drug37
Import27
Generic18
Unspecified7
Import re-registration3

By drug type

Drug typeFilings
Chemical drug124
Therapeutic biologic41
TCM10
Prophylactic biologic9

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

16 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
2小儿复方氨基酸注射液(20AA) · No verified English name212
3Ibrutinib Capsules119
4Rivaroxaban Tablets113
5Mycophenolate Mofetil Capsules114
6Doxofylline Injection115
7Levofloxacin Injection111
8Pentoxifylline Injection113
9欧米加-3-酸乙酯90软胶囊 · No verified English name110
10Terlipressin for Injection111

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

109 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized910
2Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized530
3Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.520
4Fo Shan De Rui Ke Pharmaceutical Co., Ltd. romanized510
5Pfizer Inc430
6Shanxi Kang Bao Bio Zhi Pin Co., Ltd. romanized420
7Janssen-Cilag International NV410
8Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc410
9Ke Xing Biopharmaceutical Co., Ltd. romanized410
10Eurofins Analytical Science Laboratories Inc.330

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

65 this week

AcceptedDrugApplicants
2021/04/12Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2101007 Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd.
2021/04/12New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101023 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/04/12New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101022 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/04/12New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101021 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/04/12New drug · Class 1 SKB336注射液 · No verified English nameCXSL2101020 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2021/04/12New drug · Class 1 D-0120-NA片 · No verified English nameCXHL2101029 Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized
2021/04/12New drug · Class 1 KL280006注射液 · No verified English nameCXHL2101028 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2021/04/12New drug · Class 1 KL280006注射液 · No verified English nameCXHL2101027 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2021/04/12New drug · Class 2.4 Lenvatinib Mesilate CapsulesCXHL2101026 Xian Sheng Pharma Co., Ltd. romanized
2021/04/10Import · Class 3.1 奥马珠单抗注射液 · No verified English nameJXSS2101003 Novartis Europharm Limited; Vetter Pharma-Fertigung GmbH & Co. KG; Beijing Novartis Pharma Co. Ltd.
2021/04/10Import · Class 3.1 奥马珠单抗注射液 · No verified English nameJXSS2101002 Novartis Europharm Limited; Vetter Pharma-Fertigung GmbH & Co. KG; Beijing Novartis Pharma Co. Ltd.
2021/04/10Import · Class 1 BI655130注射液 · No verified English nameJXSL2101006 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/04/10Import · Class 1 LNP023胶囊 · No verified English nameJXHL2101008 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2021/04/10Import · Class 1 LNP023胶囊 · No verified English nameJXHL2101007 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2021/04/10Generic · Class 3 小儿复方氨基酸注射液(20AA) · No verified English nameCYHS2101053 Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2021/04/10Generic · Class 3 小儿复方氨基酸注射液(20AA) · No verified English nameCYHS2101052 Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2021/04/10Generic · Class 3 Pentoxifylline InjectionCYHS2101051 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2021/04/10Generic · Class 3 Levofloxacin InjectionCYHS2101048 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2021/04/10Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2101046 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/04/10Generic · Class 3 欧米加-3-酸乙酯90软胶囊 · No verified English nameCYHS2101042 Yangtze River Pharmaceutical Group Co., Ltd
2021/04/10New drug · Class 1.2 阿可拉定软胶囊 · No verified English nameCXZS2101001 Name not romanized; Beijing Kang Er Fu Pharma Co., Ltd. romanized
2021/04/10New drug · Class 1.2 阿可拉定 · No verified English nameCXZS2101000 Name not romanized
2021/04/10New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101018 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/04/10New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101017 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/04/10New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101016 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/04/10New drug · Class 2.2 人干扰素α2b喷雾剂 · No verified English nameCXSL2101015 Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized
2021/04/10New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101014 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/04/10New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101013 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/04/10New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101012 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/04/10New drug · Class 2.2 盐酸帕洛诺司琼口颊膜 · No verified English nameCXHL2101022 Li Pin Pharma (Xiamen) Co., Ltd. romanized

35 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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