YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 439 drug applications between 2 January 2026 and 8 January 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 110, covering 73 drug names.

2026/01/02 – 2026/01/08

Period
2026/01/02 to 2026/01/08, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
439
Drugs with new generic filings (by drug name, de-duplicated)
73
Accepted this week, now under review
139

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

439filings, 110 of them generic

By application type

Application typeFilings
Supplement193
New drug113
Generic110
Import12
Unspecified10
Import re-registration1

By drug type

Drug typeFilings
Chemical drug258
TCM94
Therapeutic biologic78
Biologic5
Prophylactic biologic4

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

73 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

246 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenzhen Xin Li Tai Pharma Co., Ltd. romanized1320
2Nei Menggu Da Tang Pharma Co., Ltd. romanized12120
3Sichuan Tian De Pharmaceutical Co., Ltd. romanized990
4Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized990
5Gan Li Pharma Shandong Co., Ltd. romanized910
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized820
7Janssen-Cilag International NV810
8Guangdong Wan Nian Qing Pharmaceutical Co., Ltd. romanized660
9ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.626
10Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized610

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

149 this week

AcceptedDrugApplicants
2026/01/08Import · Class 2.4 阿托吉泮片 · No verified English nameJXHS2600002 AbbVie AG; Forest Laboratories Ireland Limited; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/01/08Import · Class 2.4 阿托吉泮片 · No verified English nameJXHS2600001 AbbVie AG; Forest Laboratories Ireland Limited; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/01/08Generic · Class 3 Elagolix TabletsCYHS2600118 Qilu Pharmaceutical (Hainan) Co., Ltd
2026/01/08Generic · Class 3 Elagolix TabletsCYHS2600117 Qilu Pharmaceutical (Hainan) Co., Ltd
2026/01/08Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2600098 Hebei Rui Jian Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized
2026/01/08Generic · Class 3 盐酸芬氟拉明口服溶液 · No verified English nameCYHS2600088 Chengdu Shuo De Pharma Co., Ltd. romanized
2026/01/08Generic · Class 3 Ferrous Succinate TabletsCYHS2600087 Tianjin Bai Hai Pharma Co., Ltd. romanized
2026/01/08Generic · Class 3 Sulindac TabletsCYHS2600077 Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2026/01/08Generic · Class 3 Sulindac TabletsCYHS2600076 Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2026/01/08Generic · Class 3 Brivaracetam TabletsCYHS2600068 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2026/01/08Generic · Class 3 Brivaracetam TabletsCYHS2600067 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2026/01/08Generic · Class 3 Brivaracetam TabletsCYHS2600066 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2026/01/08Generic · Class 3 Brivaracetam TabletsCYHS2600065 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2026/01/08New drug · Class 1.1 益肾固液颗粒 · No verified English nameCXZL2600003 Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized
2026/01/08New drug · Class 1.1 芪龙定喘片 · No verified English nameCXZL2600002 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2026/01/08New drug · Class 2.2 司普奇拜单抗注射液 · No verified English nameCXSS2600005 Chengdu Kang Nuo Xing Biopharmaceuticals Technology Co., Ltd. romanized
2026/01/08New drug · Class 2.2 司普奇拜单抗注射液 · No verified English nameCXSS2600004 Chengdu Kang Nuo Xing Biopharmaceuticals Technology Co., Ltd. romanized
2026/01/08New drug · Class 1 CM336注射液 · No verified English nameCXSL2600044 Kang Nuo Ya Biopharmaceuticals Technology Co., Ltd. romanized
2026/01/08New drug · Class 1 CM336注射液 · No verified English nameCXSL2600043 Kang Nuo Ya Biopharmaceuticals Technology Co., Ltd. romanized
2026/01/08New drug · Class 1 注射用GenSci136 · No verified English nameCXSL2600033 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/01/08New drug · Class 1 SAL0150片 · No verified English nameCXSL2600032 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/01/08New drug · Class 1 SAL0150片 · No verified English nameCXSL2600031 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/01/08New drug · Class 1 SAL0150片 · No verified English nameCXSL2600030 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/01/08New drug · Class 1 SAL0150片 · No verified English nameCXSL2600029 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/01/08New drug · Class 1 SAL0150片 · No verified English nameCXSL2600028 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/01/08New drug · Class 1 SAL0150片 · No verified English nameCXSL2600027 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/01/08New drug · Class 1 SAL0150片 · No verified English nameCXSL2600026 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/01/08New drug · Class 1 SAL0150片 · No verified English nameCXSL2600025 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/01/08New drug · Class 1 重组溶瘤腺病毒注射剂(KD01) · No verified English nameCXSL2600024 Wuhan Kai De Ji Nuo Bio Technology Co., Ltd. romanized
2026/01/08New drug · Class 1 SAL0150片 · No verified English nameCXSL2600023 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized

119 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.

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