YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 120 drug applications between 9 February 2021 and 15 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 23, covering 19 drug names.

2021/02/09 – 2021/02/15

Period
2021/02/09 to 2021/02/15, 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
120
Drugs with new generic filings (by drug name, de-duplicated)
19
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

120filings, 23 of them generic

By application type

Application typeFilings
Supplement46
Import25
New drug24
Generic23
Drug-device combination product1
Import re-registration1

By drug type

Drug typeFilings
Chemical drug91
Therapeutic biologic24
TCM3
Drug-device combination1
Prophylactic 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

19 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1阿普斯特片 · No verified English name310
2Naloxone Hydrochloride Injection211
3Dabigatran Etexilate Capsules212
4Dexketoprofen Trometamol Injection116
5Levetiracetam Tablets116
6Levofloxacin Injection111
7Vortioxetine Hydrobromide Tablets1110
8泊沙康唑注射液 · No verified English name111
9Somatostatin For Injection112
10Phenylephrine Hydrochloride Injection115

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

79 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Henan Ke Lun Pharma Co., Ltd. romanized920
2Novartis Pharma Schweiz AG320
3Allergan Pharmaceuticals Ireland310
4Merck Europe B.V.310
5Orion Corporation310
6Pfizer Inc.310
7Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized310
8Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized310
9Guangdong Dong Yang Guang Pharma Co., Ltd. romanized310
10Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized313

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

51 this week

AcceptedDrugApplicants
2021/02/11Import · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameJXSS2100009 Adimmune Corporation
2021/02/11Import · Class 3.1 注射用A型肉毒毒素 · No verified English nameJXSL2100025 Allergan Pharmaceuticals Ireland
2021/02/11Import · Class 3.1 注射用A型肉毒毒素 · No verified English nameJXSL2100024 Allergan Pharmaceuticals Ireland
2021/02/11Import · Class 3.1 注射用A型肉毒毒素 · No verified English nameJXSL2100023 Allergan Pharmaceuticals Ireland
2021/02/11Import · Class 1 IMG-020注射液 · No verified English nameJXSL2100022 Affibody AB
2021/02/11Import · Class 3.1 阿替利珠单抗注射液 · No verified English nameJXSL2100021 F.Hoffmann-La Roche Ltd
2021/02/11Import · Class 3.1 Eptinezumab注射用浓溶液 · No verified English nameJXSL2100019 Lundbeck
2021/02/11Import · Class 1 阿布昔替尼片 · No verified English nameJXHS2100022 Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH
2021/02/11Import · Class 1 阿布昔替尼片 · No verified English nameJXHS2100021 Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH
2021/02/11Import · Class 1 阿布昔替尼片 · No verified English nameJXHS2100020 Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH
2021/02/11Import · Class 1 Aramchol片 · No verified English nameJXHL2100052 Galmed Research and Development Ltd.
2021/02/11Import · Class 1 AZD9833片 · No verified English nameJXHL2100051 AstraZeneca AB
2021/02/11Import · Class 1 AZD9833片 · No verified English nameJXHL2100050 AstraZeneca AB
2021/02/11Import · Class 2.4 达罗他胺片 · No verified English nameJXHL2100049 Bayer HealthCare Pharmaceuticals Inc.
2021/02/11Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2100194 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2021/02/11New drug · Class 3.3 门冬胰岛素30注射液 · No verified English nameCXSS2100019 Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2021/02/11New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2100018 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized
2021/02/11New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2100017 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized
2021/02/11New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2100016 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized
2021/02/11New drug · Class 1 注射用间充质干细胞(脐带) · No verified English nameCXSL2100056 Tianjin Ang Sai Xi Bao Ji Yin Gong Cheng Co., Ltd. romanized
2021/02/11New drug · Class 2.4 BAT4706注射液 · No verified English nameCXSL2100050 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2021/02/11New drug · Class 2.4 BAT4706注射液 · No verified English nameCXSL2100049 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2021/02/10Import · Class 1 Pamrevlumab · No verified English nameJXSL2100020 FibroGen Inc
2021/02/09Import · Class 1 ZN-c3片 · No verified English nameJXHL2100048 Zentera Therapeutics HK Limited
2021/02/09Import · Class 1 ZN-c3片 · No verified English nameJXHL2100047 Zentera Therapeutics HK Limited
2021/02/09Import · Class 1 MK-8189 · No verified English nameJXHL2100046 Merck Sharp & Dohme International GmbH
2021/02/09Generic · Class 3 Dexketoprofen Trometamol InjectionCYHS2100190 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2021/02/09Generic · Class 3 Levofloxacin InjectionCYHS2100189 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2021/02/09Generic · Class 3 阿普斯特片 · No verified English nameCYHS2100187 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2021/02/09Generic · Class 3 阿普斯特片 · No verified English nameCYHS2100186 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized

21 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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