YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 341 drug applications between 11 January 2026 and 17 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 53 drug names.

2026/01/11 – 2026/01/17

Period
2026/01/11 to 2026/01/17, 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
341
Drugs with new generic filings (by drug name, de-duplicated)
53
Accepted this week, now under review
77

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

341filings, 74 of them generic

By application type

Application typeFilings
Supplement176
Generic74
New drug64
Import19
Import re-registration5
Unspecified3

By drug type

Drug typeFilings
Chemical drug189
TCM88
Therapeutic biologic55
Prophylactic biologic8
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
1Loxoprofen Sodium Patches6330
2Brimonidine Tartrate Eye Drops324
3Mirogabalin Besilate Tablets3161
4Adapalene And Benzoyl Peroxide Gel2230
5Deferasirox Tablets213
6复方电解质醋酸钠葡萄糖注射液 · No verified English name2122
7Dotinurad Tablets2155
8头孢呋辛酯干混悬剂 · No verified English name215
9Brivaracetam Tablets2119
10Telmisartan Tablets214

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

192 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hunan Jiu Dian Nuo Na Pharmaceuticals Technology Co., Ltd. romanized30300
2Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized1120
3Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized910
4Boehringer Ingelheim International GmbH640
5Novo Nordisk A/S620
6Hong Ji Tang Pharmaceutical (Lai Wu Qu) Co., Ltd. romanized550
7Hunan Jiudian Pharmaceutical Co., Ltd440
8Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized440
9Novartis Europharm Limited420
10Xin Da Biopharmaceutical (Suzhou) 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

103 this week

AcceptedDrugApplicants
2026/01/17Import · Class 1 FXB0871 · No verified English nameJXSL2600005 Fosun Industrial Co. Limited; Shanghai Fosun Pharmaceutical Industrial Development Company Limited.
2026/01/17Import · Class 1 Enpatoran · No verified English nameJXHL2600015 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2026/01/17Import · Class 1 RO7771950肠溶片 · No verified English nameJXHL2600014 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/01/17Import · Class 1 RO7771950片 · No verified English nameJXHL2600013 F. Hoffmann-La Roche Ltd
2026/01/17New drug · Class 3.1 温胆汤颗粒 · No verified English nameCXZS2600003 Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized
2026/01/17New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSS2600011 Yi Dao Bio Technology (Suzhou) Co., Ltd. romanized
2026/01/17New drug · Class 1 HLXTE-HAase02重组人透明质酸酶注射液 · No verified English nameCXSL2600095 Fu Xing Han Lin (Chengdu) Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2026/01/17New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2600094 Changchun Tuo Hua Pharmaceuticals Co., Ltd. romanized
2026/01/17New drug · Class 1 注射用QLS5132 · No verified English nameCXSL2600093 Qilu Pharmaceutical Co., Ltd.
2026/01/17New drug · Class 2.2 QL2107注射液 · No verified English nameCXSL2600092 Qilu Pharmaceutical Co., Ltd.
2026/01/17New drug · Class 2.2; 2.4 ZYG24004 · No verified English nameCXHL2600085 Jiangsu Ziyond Pharmaceutical Co., Ltd.
2026/01/17New drug · Class 2.2; 2.4 ZYG24004 · No verified English nameCXHL2600084 Jiangsu Ziyond Pharmaceutical Co., Ltd.
2026/01/16Import · Class 1 Budoprutug注射液 · No verified English nameJXSL2600004 Climb Bio Inc.; Beijing Mabworks Biotech Company Limited
2026/01/16Import · Class 1 奥博雷通片 · No verified English nameJXHS2600017 Takeda Pharmaceuticals U.S.A. Inc.; Takeda GmbH; Takeda (China) International Trading Co. Ltd
2026/01/16Import · Class 1 奥博雷通片 · No verified English nameJXHS2600016 Takeda Pharmaceuticals U.S.A. Inc.; Takeda GmbH; Takeda (China) International Trading Co. Ltd
2026/01/16Import · Class 1 奥博雷通片 · No verified English nameJXHS2600015 Takeda Pharmaceuticals U.S.A. Inc.; Takeda GmbH; Takeda (China) International Trading Co. Ltd
2026/01/16Import · Class 1 BI764198 片 · No verified English nameJXHL2600016 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China)Investment Co. Ltd.
2026/01/16Import · Class 1 verducatib 片 · No verified English nameJXHL2600012 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/01/16Generic · Class 3 Sodium Acetate Ringer's InjectionCYHS2600203 CISEN PHARMACEUTICAL CO., LTD.
2026/01/16Generic · Class 3 头孢呋辛酯干混悬剂 · No verified English nameCYHS2600200 Hua Bei Pharmaceutical Hebei Hua Min Pharma Co., Ltd. romanized
2026/01/16Generic · Class 3 头孢呋辛酯干混悬剂 · No verified English nameCYHS2600199 Hua Bei Pharmaceutical Hebei Hua Min Pharma Co., Ltd. romanized
2026/01/16Generic · Class 3 Deferasirox TabletsCYHS2600193 Hunan Ou Ya Pharma Co., Ltd. romanized; Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2026/01/16Generic · Class 3 Deferasirox TabletsCYHS2600192 Hunan Ou Ya Pharma Co., Ltd. romanized; Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2026/01/16Generic · Class 3 Probucol TabletsCYHS2600190 Shanxi Hua Xia Tai Kang Pharmaceuticals Group Co., Ltd. romanized; Zhejiang Pu Li Pharma Co., Ltd. romanized
2026/01/16Generic · Class 3 薁磺酸钠片 · No verified English nameCYHS2600188 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/01/16New drug · Class 1 古莫奇单抗注射液 · No verified English nameCXSS2600010 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized; Kang Fang Pharma Co., Ltd. romanized
2026/01/16New drug · Class 1 古莫奇单抗注射液 · No verified English nameCXSS2600009 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized; Kang Fang Pharma Co., Ltd. romanized
2026/01/16New drug · Class 3.4 人干扰素α2b注射液 · No verified English nameCXSS2600008 Changchun Bio Zhi Pin Research Institute Co., Ltd. romanized
2026/01/16New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2600091 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/01/16New drug · Class 1 BY002 · No verified English nameCXSL2600090 Hangzhou Bai Yi Bio Pharma Co., Ltd. romanized

73 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.