YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 191 drug applications between 10 January 2021 and 16 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 43, covering 32 drug names.

2021/01/10 – 2021/01/16

Period
2021/01/10 to 2021/01/16, 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
191
Drugs with new generic filings (by drug name, de-duplicated)
32
Accepted this week, now under review
2

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

191filings, 43 of them generic

By application type

Application typeFilings
Supplement102
Generic43
New drug26
Import15
Import re-registration5

By drug type

Drug typeFilings
Chemical drug156
Therapeutic biologic30
TCM4
In vitro diagnostic reagent1

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

32 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Pregabalin Capsules3112
2Lacosamide Oral Solution220
3Voriconazole for Injection225
4Crizotinib Capsules217
5Ipratropium Bromide Inhalation Solution212
6Piperacillin Sodium And Tazobactam Sodium For Injection215
7Thiotepa for Injection210
8Duloxetine Hydrochloride Enteric Capsules214
9Citicoline Sodium Injection213
10Dabigatran Etexilate Capsules212

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

116 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novartis Pharma Schweiz AG740
2Gan Li Pharma Co., Ltd. romanized530
3GUERBET510
4Changchun Jin Sai Pharma Co., Ltd. romanized510
5Yangtze River Pharmaceutical Group Co., Ltd443
6YaoPharma Co., Ltd.420
7Sichuan Tai Ping Yang Pharma Co., Ltd. romanized410
8Shenzhen Xin Li Tai Pharma Co., Ltd. romanized410
9Xian Yang Sen Pharmaceutical Co., Ltd. romanized410
10Yunnan Sheng Qu Jing Pharma Co., Ltd. romanized330

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

44 this week

AcceptedDrugApplicants
2021/01/16Import · Class 1 JDQ443片 · No verified English nameJXHL2100017 Novartis Pharma AG
2021/01/16Import · Class 1 JDQ443片 · No verified English nameJXHL2100016 Novartis Pharma AG
2021/01/16Import · Class 1 BI 425809 片 · No verified English nameJXHL2100015 Boehringer Ingelheim International GmbH
2021/01/16New drug · Class 2 乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒(1+2型)核酸检测试剂盒(PCR-荧光法) · No verified English nameCXSS2100010 Suzhou Xin Bo Bio Technology Co., Ltd. romanized
2021/01/16New drug · Class 2.4 重组抗EGFR人鼠嵌合单克隆抗体注射液 · No verified English nameCXSL2100015 Bao Chuan Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2021/01/16New drug · Class 2.4 Posaconazole Enteric-coated TabletsCXHL2100031 Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized
2021/01/16New drug · Class 2.4 Posaconazole Enteric-coated TabletsCXHL2100030 Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized
2021/01/16New drug · Class 1 SAL0104胶囊 · No verified English nameCXHL2100022 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2021/01/15Generic · Class 3 Thiotepa for InjectionCYHS2100063 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/01/15Generic · Class 3 Thiotepa for InjectionCYHS2100062 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/01/15Generic · Class 3 Citicoline Sodium InjectionCYHS2100061 Shandong Yu Man Kun Bio Technology Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2021/01/15Generic · Class 3 Citicoline Sodium InjectionCYHS2100060 Shandong Yu Man Kun Bio Technology Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2021/01/15New drug · Class 1 SY-5007片 · No verified English nameCXHL2100028 Shou Yao Holding (Beijing) Co., Ltd. romanized
2021/01/15New drug · Class 1 SY-5007片 · No verified English nameCXHL2100027 Shou Yao Holding (Beijing) Co., Ltd. romanized
2021/01/15New drug · Class 2.2 TTYP01片 · No verified English nameCXHL2100026 Suzhou Ao Zong Bio Technology Co., Ltd. romanized
2021/01/15New drug · Class 2.2 富马酸福莫特罗吸入气雾剂 · No verified English nameCXHL2100025 Health Yuan Pharma Group Co., Ltd. romanized
2021/01/15New drug · Class 2.2 富马酸福莫特罗吸入气雾剂 · No verified English nameCXHL2100024 Health Yuan Pharma Group Co., Ltd. romanized
2021/01/14Import · Class 3.1 注射用奥马珠单抗 · No verified English nameJXSS2100003 Novartis Europharm Limited; Novartis Pharma Stein AG
2021/01/14Generic · Class 3 Magnesium Sulfate InjectionCYHS2100057 Shanghai He Feng Pharmaceutical Co., Ltd. romanized
2021/01/14New drug · Class 1 替戈拉生片 · No verified English nameCXHS2000047 Shandong Luo Xin Pharma Group Co., Ltd. romanized
2021/01/14New drug · Class 1 SAL0104胶囊 · No verified English nameCXHL2100023 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2021/01/13Import · Class 2.2 sacituzumab govitecan · No verified English nameJXSL2100007 Everest Medicines II (HK) Limited
2021/01/13Import · Class 2.4 Upadacitinib Sustained-release TabletsJXHS2100004 AbbVie Deutschland GmbH & Co.KG; AbbVie Ireland NL B.V.
2021/01/13Generic · Class 3 Desonide CreamCYHS2100046 Fu Yuan Pharma Co., Ltd. romanized
2021/01/13New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSS2100009 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/01/13New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSS2100008 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/01/13New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSS2100007 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/01/13New drug · Class 3.3 重组GLP-1受体激动剂注射液 · No verified English nameCXSL2100013 Beijing Le Pu Pharmaceuticals Technology Co., Ltd. romanized
2021/01/13New drug · Class 1 SAL0104胶囊 · No verified English nameCXHL2100021 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2021/01/13New drug · Class 1 SAL0104胶囊 · No verified English nameCXHL2100020 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized

14 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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