YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 270 drug applications between 3 February 2021 and 9 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 40 drug names.

2021/02/03 – 2021/02/09

Period
2021/02/03 to 2021/02/09, 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
270
Drugs with new generic filings (by drug name, de-duplicated)
40
Accepted this week, now under review
3

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

270filings, 53 of them generic

By application type

Application typeFilings
Supplement101
New drug56
Generic53
Import36
Unspecified12
Import re-registration12

By drug type

Drug typeFilings
Chemical drug217
Therapeutic biologic36
TCM13
Biologic3
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

40 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Duloxetine Hydrochloride Enteric Capsules314
2阿普斯特片 · No verified English name310
3盐酸左沙丁胺醇雾化吸入溶液 · No verified English name222
4Metaraminol Tartrate Injection222
5Vortioxetine Hydrobromide Tablets2110
6Tranexamic Acid Injection2111
7Tirofiban Hydrochloride And Sodium Chloride Injection212
8Naloxone Hydrochloride Injection211
9Eldecalcitol Soft Capsules218
10莫米松福莫特罗吸入气雾剂 · No verified English name210

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

169 companies with new acceptances; top 10 listed

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

106 this week

AcceptedDrugApplicants
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
2021/02/09Generic · Class 3 阿普斯特片 · No verified English nameCYHS2100185 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2021/02/09Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2100179 Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2021/02/09Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2100178 Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2021/02/09Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2100177 Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized; Yangtze River Pharmaceutical Group Co., Ltd
2021/02/09New drug · Class 1 T3011疱疹病毒注射液 · No verified English nameCXSL2100055 Shenzhen Shi Yi Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/02/09New drug · Class 1 BGB-A1217注射液 · No verified English nameCXSL2100054 Bai Ji Shen Zhou (Guangzhou) Bio Technology Co., Ltd. romanized
2021/02/09New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2100053 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2021/02/09New drug · Class 1 靶向间皮素嵌合抗原受体NK细胞注射液 · No verified English nameCXSL2100052 Guo Jian Cheng Nuo Bio Technology (Beijing) Co., Ltd. romanized
2021/02/09New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2100051 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2021/02/09New drug · Class 2.4 注射用甲苯磺酸瑞马唑仑 · No verified English nameCXHS2100004 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/02/09New drug · Class 1 注射用BGC0228 · No verified English nameCXHL2100112 Bo Rui Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2021/02/09New drug · Class 1 SY-4835片 · No verified English nameCXHL2100111 Shou Yao Holding (Beijing) Co., Ltd. romanized
2021/02/09New drug · Class 1 SY-4835片 · No verified English nameCXHL2100110 Shou Yao Holding (Beijing) Co., Ltd. romanized
2021/02/09New drug · Class 1 SY-4835片 · No verified English nameCXHL2100109 Shou Yao Holding (Beijing) Co., Ltd. romanized
2021/02/09New drug · Class 2.2 Vilazodone Hydrochloride TabletsCXHL2100106 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2021/02/09New drug · Class 2.2 Vilazodone Hydrochloride TabletsCXHL2100105 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2021/02/09New drug · Class 2.2 Vilazodone Hydrochloride TabletsCXHL2100104 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2021/02/09New drug · Class 1 KL210122片 · No verified English nameCXHL2100103 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2021/02/09New drug · Class 1 KL210122片 · No verified English nameCXHL2100102 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2021/02/09New drug · Class 1 KL210122片 · No verified English nameCXHL2100101 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2021/02/09New drug · Class 2.2 HR20005凝胶 · No verified English nameCXHL2100100 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2021/02/08Import · Class 3.1 重组人促卵泡激素δ注射液 · No verified English nameJXSS2100014 Ferring Pharmaceuticals A/S; Vetter Pharma-Fertigung GmbH & Co.KG
2021/02/08Import · Class 3.1 重组人促卵泡激素δ注射液 · No verified English nameJXSS2100013 Ferring Pharmaceuticals A/S; Vetter Pharma-Fertigung GmbH & Co.KG

76 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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