YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 45 drug applications between 30 September 2026 and 6 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 8, covering 7 drug names.

2026/09/30 – 2026/10/06

Period
2026/09/30 to 2026/10/06, 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
45
Drugs with new generic filings (by drug name, de-duplicated)
7
Accepted this week, now under review
33

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

45filings, 8 of them generic

By application type

Application typeFilings
Supplement24
Generic8
New drug8
Import re-registration3
Unspecified1
Import1

By drug type

Drug typeFilings
Chemical drug26
TCM10
Therapeutic 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

7 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dotinurad Tablets2155
2ω-3 Fish Oil Fat Emulsion Injection116
3Acetylcysteine Tablets118
4Sodium Ibandronate Injection114
5Levofloxacin Injection111
6氧(液态) · No verified English name1113
7Tranexamic Acid Tablets119

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

34 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AbbVie Limited310
2Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized220
3Shanghai Si Pu Rui Pharmaceuticals Technology Co., Ltd. romanized210
4Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized210
5NORTH CHINA PHARMACEUTICAL COMPANY.LTD212
6Hangzhou Du Yi Technology Co., Ltd. romanized210
7Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized210
8Shenzhen Hua Run Jiu Chuang Pharmaceuticals Co., Ltd. romanized210
9Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized210
10Chongqing Xing Chuang Pharmaceuticals Co., Ltd. romanized210

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

11 this week

AcceptedDrugApplicants
2026/09/30Import · Class 2.2 伊奈利珠单抗注射液 · No verified English nameJXSL2600262 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/09/30Generic · Class 3 Acetylcysteine TabletsCYHS2602434 Guangdong Sai Kang Pharmaceutical Factory Co., Ltd. romanized
2026/09/30Generic · Class 3 Levofloxacin InjectionCYHS2602433 Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2026/09/30New drug · Class 1 注射用AST1001 · No verified English nameCXSL2601080 Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized
2026/09/30New drug · Class 1 RG002-03注射液 · No verified English nameCXSL2601079 Ren Jing (Suzhou) Bio Technology Co., Ltd. romanized; Zhongguo Yi Xue Ke College Pharmaceuticals Bio Technology Research Institute romanized
2026/09/30New drug · Class 1 ALXN2220注射液 · No verified English nameCXSL2601078 A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized
2026/09/30New drug · Class 1 SI-B037双特异性抗体注射液 · No verified English nameCXSL2601077 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/09/30New drug · Class 2.2; 2.4 BTS1115 · No verified English nameCXHL2601220 Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized
2026/09/30New drug · Class 1 SPR2015片 · No verified English nameCXHL2601219 Shanghai Si Pu Rui Pharmaceuticals Technology Co., Ltd. romanized
2026/09/30New drug · Class 1 SPR2015片 · No verified English nameCXHL2601218 Shanghai Si Pu Rui Pharmaceuticals Technology Co., Ltd. romanized
2026/09/30New drug · Class 1 HJY-39注射液 · No verified English nameCXHL2601217 Xiamen Gan Bao Li Biopharmaceuticals Co., Ltd. romanized

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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