YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 354 drug applications between 1 January 2026 and 7 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 81, covering 61 drug names.

2026/01/01 – 2026/01/07

Period
2026/01/01 to 2026/01/07, 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
354
Drugs with new generic filings (by drug name, de-duplicated)
61
Accepted this week, now under review
111

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

354filings, 81 of them generic

By application type

Application typeFilings
Supplement169
New drug84
Generic81
Unspecified10
Import10

By drug type

Drug typeFilings
Chemical drug210
TCM79
Therapeutic biologic56
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

61 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

205 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Da Tang Pharma Co., Ltd. romanized12120
2Sichuan Tian De Pharmaceutical Co., Ltd. romanized990
3Gan Li Pharma Shandong Co., Ltd. romanized910
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized820
5Janssen-Cilag International NV810
6Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized770
7Guangdong Wan Nian Qing Pharmaceutical Co., Ltd. romanized660
8Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized610
9Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized510
10Hunan Jiudian Pharmaceutical Co., Ltd442

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

107 this week

AcceptedDrugApplicants
2026/01/07Generic · Class 3 Methyldopa TabletsCYHS2600061 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized
2026/01/07Generic · Class 3 恩格列净二甲双胍缓释片(IV) · No verified English nameCYHS2600054 Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
2026/01/07New drug · Class 3.1 易黄汤颗粒 · No verified English nameCXZS2600002 Su Zhou Yi Fan Pharma Co., Ltd. romanized
2026/01/07New drug · Class 3.4 人凝血因子IX · No verified English nameCXSS2600002 Guangdong Shuang Lin Biopharmaceutical Co., Ltd. romanized
2026/01/07New drug · Class 1 SH009注射液 · No verified English nameCXSL2600018 Nanjing Sheng He Pharma Co., Ltd. romanized
2026/01/07New drug · Class 1 BM230冻干制剂 · No verified English nameCXSL2600017 Suzhou Bo Ao Ming Sai Biopharmaceutical Co., Ltd. romanized
2026/01/07New drug · Class 1 HS-20117注射液 · No verified English nameCXSL2600016 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/01/07New drug · Class 1 注射用SHR-1826 · No verified English nameCXSL2600015 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/01/07New drug · Class 2.2 艾司奥美拉唑镁碳酸氢钠干混悬剂(Ⅰ) · No verified English nameCXHS2600004 Hainan Ling Kang Pharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2026/01/07New drug · Class 2.2 艾司奥美拉唑镁碳酸氢钠干混悬剂(Ⅰ) · No verified English nameCXHS2600003 Hainan Ling Kang Pharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2026/01/07New drug · Class 1 ICP-538片 · No verified English nameCXHL2600035 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2026/01/07New drug · Class 1 ICP-538片 · No verified English nameCXHL2600034 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2026/01/07New drug · Class 1 ICP-538片 · No verified English nameCXHL2600033 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2026/01/07New drug · Class 2.4 SL-0044 · No verified English nameCXHL2600032 Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized
2026/01/07New drug · Class 2.4 SL-0044 · No verified English nameCXHL2600031 Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized
2026/01/07New drug · Class 2.4 SL-0044 · No verified English nameCXHL2600030 Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized
2026/01/07New drug · Class 2.4 SL-0044 · No verified English nameCXHL2600029 Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized
2026/01/07New drug · Class 2.4 SL-0044 · No verified English nameCXHL2600028 Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized
2026/01/07New drug · Class 2.2; 2.4 吸入用PRT-050 · No verified English nameCXHL2600027 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2026/01/07New drug · Class 1 HS-10241片 · No verified English nameCXHL2600026 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/01/07New drug · Class 1 HS-10241片 · No verified English nameCXHL2600025 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/01/07New drug · Class 1 LG-0317片 · No verified English nameCXHL2600024 Lin Gang Guo Jia Laboratory romanized
2026/01/07New drug · Class 1 LG-0317片 · No verified English nameCXHL2600023 Lin Gang Guo Jia Laboratory romanized
2026/01/07New drug · Class 1 LG-0317片 · No verified English nameCXHL2600022 Lin Gang Guo Jia Laboratory romanized
2026/01/07New drug · Class 1 SAL0145注射液 · No verified English nameCXHL2600021 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/01/07New drug · Class 1 HS-10529胶囊 · No verified English nameCXHL2600020 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/01/06Import · Class 1 177Lu-PSMA I&T注射液 · No verified English nameJXHL2600006 Curium US LLC; Beijing Regitrans Consulting Co. Ltd.
2026/01/06Import · Class 2.4 ABL001片 · No verified English nameJXHL2600005 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/01/06Import · Class 2.4 ABL001胶囊装颗粒 · No verified English nameJXHL2600004 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/01/06Import · Class 2.4 ABL001胶囊装颗粒 · No verified English nameJXHL2600003 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.

77 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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