YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 209 drug applications between 9 April 2021 and 15 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 24, covering 20 drug names.

2021/04/09 – 2021/04/15

Period
2021/04/09 to 2021/04/15, 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
209
Drugs with new generic filings (by drug name, de-duplicated)
20
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

209filings, 24 of them generic

By application type

Application typeFilings
Supplement137
New drug25
Generic24
Import14
Import re-registration5
Unspecified3
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug155
Therapeutic biologic36
TCM9
Prophylactic biologic8
Biologic1

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

20 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Palbociclib Capsules310
2小儿复方氨基酸注射液(20AA) · No verified English name212
3Lacosamide Tablets210
4Desloratadine Tablets110
5Doxofylline Injection115
6Tenofovir alafenamide Fumarate Tablets110
7Levofloxacin and Sodium Chloride Injection1114
8Levofloxacin Injection111
9Pentoxifylline Injection113
10Dutasteride Soft Capsules110

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

102 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Qi Lu An Ti Pharmaceutical Co., Ltd. romanized40180
2Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized910
3Janssen-Cilag International NV720
4Merck Sharp & Dohme Corp.420
5Pfizer Europe MA EEIG420
6Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc410
7Ke Xing Biopharmaceutical Co., Ltd. romanized410
8Novartis Pharma AG320
9Beijing Foyou Pharma CO.,LTD321
10Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized320

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

42 this week

AcceptedDrugApplicants
2021/04/15New drug · Class 1 UB-421注射液 · No verified English nameCXSL2101027 Lian Yao (Shanghai) Bio Technology Co., Ltd. romanized
2021/04/15New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101025 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/04/15New drug · Class 1 注射用HRS3658 · No verified English nameCXHL2101034 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2021/04/15New drug · Class 1 赛沃替尼片 · No verified English nameCXHL2101033 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2021/04/15New drug · Class 1 赛沃替尼片 · No verified English nameCXHL2101032 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2021/04/15New drug · Class 2.3 阿利沙坦酯吲达帕胺缓释片 · No verified English nameCXHL2101031 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2021/04/14Import · Class 1 Efgartigimod注射液 · No verified English nameJXSL2101010 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2021/04/14Import · Class 1 Efgartigimod注射液 · No verified English nameJXSL2101009 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2021/04/14Import · Class 2.2 Benralizumab注射液 · No verified English nameJXSL2101008 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2021/04/14Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2101059 Guangzhou Nan Xin Pharmaceutical Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized
2021/04/14Generic · Class 3 Leflunomide TabletsCYHS2101058 Mei Luo Pharma Co., Ltd. romanized
2021/04/14New drug · Class 2.4 甲磺酸伏美替尼片 · No verified English nameCXHL2101030 Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized
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

12 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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