YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 371 drug applications between 20 January 2026 and 26 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 53 drug names.

2026/01/20 – 2026/01/26

Period
2026/01/20 to 2026/01/26, 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
371
Drugs with new generic filings (by drug name, de-duplicated)
53
Accepted this week, now under review
96

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

371filings, 72 of them generic

By application type

Application typeFilings
Supplement171
New drug80
Generic72
Import34
Unspecified10
Import re-registration4

By drug type

Drug typeFilings
Chemical drug224
Therapeutic biologic89
TCM54
Biologic2
In vitro diagnostic reagent1
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

53 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapagliflozin Tablets4284
2醋酸艾司利卡西平片 · No verified English name414
3西诺氨酯片 · No verified English name3124
4Perindopril tert-Butylamine Tablets215
5Nimodipine Oral Solution214
6Budesonide Nasal Spray213
7Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation2112
8Phenylephrine Hydrochloride Injection215
9Bromhexine Hydrochloride Oral Solution2122
10Ziprasidone Hydrochloride Capsules219

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

211 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1830
2Shaanxi Pharmaceuticals Holding Group Bio Zhi Pin (Han Zhong) Co., Ltd. romanized970
3Kashima Plant Eisai Co. Ltd.660
4Pfizer Inc.630
5Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized630
6Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized550
7Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized510
8Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized420
9Shijiazhuang Gree Pharmaceutical Co., Ltd422
10AstraZeneca AB410

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

135 this week

AcceptedDrugApplicants
2026/01/26Generic · Class 3 Lansoprazole For InjectionCYHS2600280 Shanxi De Yuan Tang Pharma Co., Ltd. romanized
2026/01/26Generic · Class 3 小儿复方氨基酸注射液(20AA) · No verified English nameCYHS2600276 Shandong Qidu Pharmaceutical Co., Ltd.
2026/01/26New drug · Class 1 BG-A3004注射液 · No verified English nameCXSL2600129 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2026/01/26New drug · Class 1 EA5注射液皮下制剂 · No verified English nameCXSL2600126 Shandong Lan Yi Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Lan Yi Pharmaceuticals Technology Co., Ltd. romanized
2026/01/26New drug · Class 2.1; 2.2 泰它西普注射液 · No verified English nameCXSL2600125 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2026/01/26New drug · Class 1 BCR-0003片 · No verified English nameCXHL2600123 Zhejiang Zhong Shen Innovation Pharmaceuticals Technology Co., Ltd. romanized
2026/01/26New drug · Class 1 BCR-0003片 · No verified English nameCXHL2600122 Zhejiang Zhong Shen Innovation Pharmaceuticals Technology Co., Ltd. romanized
2026/01/26New drug · Class 1 DC561043片 · No verified English nameCXHL2600121 Zhongguo Ke College Shanghai Drug Research Institute romanized; Lin Gang Guo Jia Laboratory romanized
2026/01/24Generic · Class 3 醋酸艾司利卡西平片 · No verified English nameCYHS2600270 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized
2026/01/24Generic · Class 3 醋酸艾司利卡西平片 · No verified English nameCYHS2600269 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized
2026/01/24Generic · Class 3 醋酸艾司利卡西平片 · No verified English nameCYHS2600268 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized
2026/01/24Generic · Class 3 醋酸艾司利卡西平片 · No verified English nameCYHS2600267 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized
2026/01/24New drug · Class 1 RSS0393乳胶 · No verified English nameCXHL2600120 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2026/01/24New drug · Class 1 RSS0393乳胶 · No verified English nameCXHL2600119 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2026/01/24New drug · Class 1 RSS0393乳胶 · No verified English nameCXHL2600118 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2026/01/24New drug · Class 1 SYH2069注射液 · No verified English nameCXHL2600117 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD.
2026/01/24New drug · Class 1 SYH2069注射液 · No verified English nameCXHL2600116 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD.
2026/01/24New drug · Class 1 SYH2069注射液 · No verified English nameCXHL2600115 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD.
2026/01/24New drug · Class 1 ACC085注射液 · No verified English nameCXHL2600114 Jiangsu Ai Di Pharma Group Co., Ltd. romanized; Lu Zhou Ai Di Pharmaceuticals Technology Co., Ltd. romanized
2026/01/24New drug · Class 1 HSK47388片(I) · No verified English nameCXHL2600113 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2026/01/24New drug · Class 1 HSK47388片(I) · No verified English nameCXHL2600112 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2026/01/23Import · Class 1 PF-08634404 · No verified English nameJXSL2600024 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/01/23Import · Class 1 PF-08634404 · No verified English nameJXSL2600023 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/01/23Import · Class 1 Bleximenib片 · No verified English nameJXHL2600029 Stichting Hemato-Oncologie voor Volwassenen Nederland; PPD Pharmaceutical Development (Beijing) Co. Ltd
2026/01/23Import · Class 1 Bleximenib片 · No verified English nameJXHL2600028 Stichting Hemato-Oncologie voor Volwassenen Nederland; PPD Pharmaceutical Development (Beijing) Co. Ltd
2026/01/23Import · Class 1 HTT227片 · No verified English nameJXHL2600027 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/01/23Generic · Class 3 Piracetam InjectionCYHS2600266 Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized
2026/01/23Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2600259 Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2026/01/23Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2600258 Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2026/01/23New drug · Class 1.1 丹元糖痹软膏 · No verified English nameCXZL2600012 Xing Lin Zhong Pharmaceuticals Technology (Guangzhou) Co., Ltd. romanized

105 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.