YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 451 drug applications between 7 January 2026 and 13 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 119, covering 78 drug names.

2026/01/07 – 2026/01/13

Period
2026/01/07 to 2026/01/13, 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
451
Drugs with new generic filings (by drug name, de-duplicated)
78
Accepted this week, now under review
160

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

451filings, 119 of them generic

By application type

Application typeFilings
Supplement172
New drug133
Generic119
Import18
Unspecified6
Import re-registration3

By drug type

Drug typeFilings
Chemical drug279
TCM86
Therapeutic biologic80
Prophylactic biologic5
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

78 drugs with new generic filings; top 10 listed

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

240 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hunan Jiu Dian Nuo Na Pharmaceuticals Technology Co., Ltd. romanized23230
2Shenzhen Xin Li Tai Pharma Co., Ltd. romanized1320
3Eli Lilly Nederland B.V.1210
4Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized1210
5Bayer Vital GmbH840
6Gan Li Pharma Shandong Co., Ltd. romanized810
7Jiangsu Hao Sen Pharma Group Co., Ltd. romanized740
8ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.737
9Name not romanized610
10Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized550

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

184 this week

AcceptedDrugApplicants
2026/01/13Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2600163 Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2026/01/13Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2600162 Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2026/01/13Generic · Class 3 维生素K?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2600155 Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2026/01/13Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2600153 Henan Shuang He Hua Li Pharma Co., Ltd. romanized
2026/01/13Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2600152 Henan Shuang He Hua Li Pharma Co., Ltd. romanized
2026/01/13Generic · Class 3 Acetylcysteine TabletsCYHS2600151 Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized
2026/01/13Generic · Class 3 Brivaracetam TabletsCYHS2600146 Chengdu Ao Bang Pharma Co., Ltd. romanized
2026/01/13Generic · Class 3 Brivaracetam TabletsCYHS2600145 Chengdu Ao Bang Pharma Co., Ltd. romanized
2026/01/13Generic · Class 3 Brimonidine Tartrate Eye DropsCYHL2600009 Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized
2026/01/13Generic · Class 3 Brimonidine Tartrate Eye DropsCYHL2600008 Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized
2026/01/13Generic · Class 3 Ulipristal Acetate TabletsCYHL2600007 Hangzhou Tian Cheng Tai Feng Pharma Co., Ltd. romanized
2026/01/13New drug · Class 1 VG801 · No verified English nameCXSL2600074 De Kang Ming Ji Medical Technology (Shanghai) Co., Ltd. romanized
2026/01/13New drug · Class 1 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2600073 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2026/01/13New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2600072 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/01/13New drug · Class 1 FKC289注射液 · No verified English nameCXSL2600071 Fu Xing Kai Rui (Shanghai) Bio Technology Co., Ltd. romanized
2026/01/13New drug · Class 3.3 度普利尤单抗注射液 · No verified English nameCXSL2600070 Hua Run Biopharmaceuticals Co., Ltd. romanized
2026/01/13New drug · Class 1 GK001片 · No verified English nameCXHL2600069 Hangzhou Gang Kang Pharmaceuticals Co., Ltd. romanized
2026/01/13New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600068 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/01/13New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600067 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/01/13New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600066 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/01/13New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600065 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/01/13New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600064 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/01/13New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600063 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/01/13New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600062 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/01/13New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600061 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/01/13New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600060 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/01/13New drug · Class 1 HRS-5765片 · No verified English nameCXHL2600059 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/01/13New drug · Class 1 HRS-5765片 · No verified English nameCXHL2600058 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/01/12New drug · Class 1 注射用SKB103 · No verified English nameCXSL2600069 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/01/12New drug · Class 1 BG-A3004注射液 · No verified English nameCXSL2600068 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized

154 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.