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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 582 drug applications between 5 January 2026 and 11 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 147, covering 96 drug names.

2026/01/05 – 2026/01/11

Period
2026/01/05 to 2026/01/11, 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
582
Drugs with new generic filings (by drug name, de-duplicated)
96
Accepted this week, now under review
205

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

582filings, 147 of them generic

By application type

Application typeFilings
Supplement245
New drug149
Generic147
Import24
Unspecified14
Import re-registration3

By drug type

Drug typeFilings
Chemical drug353
TCM112
Therapeutic biologic105
Biologic6
Prophylactic biologic6

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

96 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

315 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Gan Li Pharma Shandong Co., Ltd. romanized1710
2Shenzhen Xin Li Tai Pharma Co., Ltd. romanized1320
3Eli Lilly Nederland B.V.1210
4Nei Menggu Da Tang Pharma Co., Ltd. romanized990
5Sichuan Tian De Pharmaceutical Co., Ltd. romanized990
6Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized990
7Hunan Jiu Dian Nuo Na Pharmaceuticals Technology Co., Ltd. romanized880
8Janssen-Cilag International NV810
9Jiangsu Hao Sen Pharma Group Co., Ltd. romanized740
10Bayer Vital GmbH730

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

208 this week

AcceptedDrugApplicants
2026/01/10Import · Class 1 奥氟格列隆片 · No verified English nameJXHS2600014 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片 · No verified English nameJXHS2600013 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片 · No verified English nameJXHS2600012 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片 · No verified English nameJXHS2600011 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片 · No verified English nameJXHS2600010 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片 · No verified English nameJXHS2600009 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片 · No verified English nameJXHS2600008 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片 · No verified English nameJXHS2600007 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片 · No verified English nameJXHS2600006 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片 · No verified English nameJXHS2600005 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片 · No verified English nameJXHS2600004 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片 · No verified English nameJXHS2600003 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Generic · Class 3 Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral SolutionCYHS2600137 Nanjing Kang Chuan Ji Pharmaceuticals Technology Co., Ltd. romanized; Rui Hua (Zhong Shan) Pharmaceutical Co., Ltd. romanized
2026/01/10Generic · Class 3 Ramelteon TabletsCYHS2600136 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2026/01/10Generic · Class 3 盐酸精氨酸注射液 · No verified English nameCYHS2600130 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2026/01/10Generic · Class 3 尿素[13C]片呼气试验药盒 · No verified English nameCYHL2600006 HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2026/01/10Generic · Class 3 Relugolix TabletsCYHL2600005 Hangzhou Minsheng Pharmaceutical Co., Ltd
2026/01/10New drug · Class 1.1 固表通窍颗粒 · No verified English nameCXZL2600004 Jiu Hua Hua Yuan Pharma Co., Ltd. romanized
2026/01/10New drug · Class 2.2 恩沃利单抗注射液 · No verified English nameCXSS2600007 Sichuan Si Lu Kang Rui Pharma Co., Ltd. romanized; Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2026/01/10New drug · Class 1.2 YKYY025注射液 · No verified English nameCXSL2600066 Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized
2026/01/10New drug · Class 1 AK117注射液 · No verified English nameCXSL2600065 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2026/01/10New drug · Class 1 AK117注射液 · No verified English nameCXSL2600064 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2026/01/10New drug · Class 1 AK109注射液 · No verified English nameCXSL2600063 Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized
2026/01/10New drug · Class 1 注射用AK138D1 · No verified English nameCXSL2600062 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2026/01/10New drug · Class 1 注射用AK146D1 · No verified English nameCXSL2600061 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2026/01/10New drug · Class 3.4 人凝血酶 · No verified English nameCXSL2600060 Guangdong Shuang Lin Biopharmaceutical Co., Ltd. romanized
2026/01/10New drug · Class 1 TQB2922注射液 · No verified English nameCXSL2600059 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/01/10New drug · Class 1 TQB2922注射液 · No verified English nameCXSL2600058 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/01/10New drug · Class 1 GZR18 · No verified English nameCXSL2600057 Gan Li Pharma Shandong Co., Ltd. romanized
2026/01/10New drug · Class 1 GZR18 · No verified English nameCXSL2600056 Gan Li Pharma Shandong Co., Ltd. romanized

178 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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