YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 29 drug applications between 28 January 2025 and 3 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 10, covering 9 drug names.

2025/01/28 – 2025/02/03

Period
2025/01/28 to 2025/02/03, 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
29
Drugs with new generic filings (by drug name, de-duplicated)
9
Accepted this week, now under review
0

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

29filings, 10 of them generic

By application type

Application typeFilings
Supplement12
Generic10
New drug6
Unspecified1

By drug type

Drug typeFilings
Chemical drug21
Therapeutic biologic4
TCM2
Biologic1
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

9 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Amoxicillin Sodium and Clavulanate Potassium for Injection214
2泊沙康唑注射液 · No verified English name111
3Amiodarone Hydrochloride Injection110
4碳酸氢钠/葡萄糖2mmol/L钾电解质血滤置换液 · No verified English name110
5磷/碳酸氢钠血滤置换液 · No verified English name114
6Oseltamivir Phosphate Capsules1139
7Oxytocin Injection118
8Calcium Acetate Oral Solution111
9Alendronate Sodium Oral Solution117

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

22 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Haikou Shi Pharmaceutical Factory Co., Ltd. romanized310
2Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized222
3Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized220
4Biohaven Therapeutics Ltd210
5Shandong An Xin Pharmaceutical Co., Ltd. romanized212
6Xian Li Jun Pharmaceutical Co., Ltd. romanized210
7Terumo Corporation Kofu Factory110
8Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized110
9Huayi Pharmaceuticals (Anhui) Co., Ltd.111
10Tianjin Shi Zhong Yang Pharma Co., Ltd. romanized110

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

10 this week

AcceptedDrugApplicants
2025/01/28Generic · Class 3 Calcium Acetate Oral SolutionCYHS2500553 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/01/28Generic · Class 3 Oxytocin InjectionCYHS2500550 Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized
2025/01/28Generic · Class 3 碳酸氢钠/葡萄糖2mmol/L钾电解质血滤置换液 · No verified English nameCYHS2500549 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/01/28Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2500547 Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2025/01/28New drug · Class 3.3 吸附破伤风疫苗 · No verified English nameCXSS2500022 Kang Xi Nuo Bio Shareholding Company romanized
2025/01/28New drug · Class 1 重组抗人EGFR抗体/IL-10双特异Fc融合蛋白注射液 · No verified English nameCXSL2500098 Shi Hui Da Pharma Group (Jilin) Co., Ltd. romanized
2025/01/28New drug · Class 1 注射用SIM0686 · No verified English nameCXSL2500097 Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized
2025/01/28New drug · Class 1 BNT327 · No verified English nameCXSL2500096 Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized; Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2025/01/28New drug · Class 1 BNT326 · No verified English nameCXSL2500095 Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized; Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2025/01/28New drug · Class 1 HRS-9813胶囊 · No verified English nameCXHL2500147 Guangdong Heng Rui Pharmaceuticals 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.

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.