YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 223 drug applications between 9 January 2021 and 15 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 37 drug names.

2021/01/09 – 2021/01/15

Period
2021/01/09 to 2021/01/15, 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
223
Drugs with new generic filings (by drug name, de-duplicated)
37
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

223filings, 48 of them generic

By application type

Application typeFilings
Supplement115
Generic48
New drug37
Import18
Import re-registration5

By drug type

Drug typeFilings
Chemical drug174
Therapeutic biologic40
TCM8
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

37 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Pregabalin Capsules3112
2Tofacitinib Citrate Tablets221
3Voriconazole for Injection225
4Crizotinib Capsules217
5Ipratropium Bromide Inhalation Solution212
6Piperacillin Sodium And Tazobactam Sodium For Injection215
7Pemetrexed Disodium for Injection214
8Thiotepa for Injection210
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

134 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novartis Pharma Schweiz AG740
2Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized610
3Qilu Pharmaceutical Co., Ltd.543
4YaoPharma Co., Ltd.531
5Pfizer Inc.520
6GUERBET510
7Changchun Jin Sai Pharma Co., Ltd. romanized510
8Yangtze River Pharmaceutical Group Co., Ltd443
9Shenzhen Xin Li Tai Pharma Co., Ltd. romanized420
10Gan Li Pharma Co., Ltd. romanized420

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

60 this week

AcceptedDrugApplicants
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
2021/01/13New drug · Class 2.3 注射用TQD3606 · No verified English nameCXHL2100019 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/01/13New drug · Class 2.2 他达拉非口溶膜 · No verified English nameCXHL2100018 Li Pin Pharma (Xiamen) Co., Ltd. romanized
2021/01/13New drug · Class 2.2 他达拉非口溶膜 · No verified English nameCXHL2100017 Li Pin Pharma (Xiamen) Co., Ltd. romanized
2021/01/12Import · Class 1 VB4-845注射液 · No verified English nameJXSL2100006 Sesen Bio Inc.
2021/01/12Import · Class 1 SHR8008胶囊 · No verified English nameJXHL2100013 eVENUS PHARMACEUTICAL LABORATORIES INC.
2021/01/11Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2100038 Suzhou Erye Pharmaceutical Co., Ltd
2021/01/11Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2100033 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2021/01/11Generic · Class 3 Salbutamol Sulfate injectionCYHS2100032 Chengdu Brilliant Pharmaceutical Co., Ltd.

30 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.