YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 461 drug applications between 6 January 2026 and 12 January 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 117, covering 79 drug names.

2026/01/06 – 2026/01/12

Period
2026/01/06 to 2026/01/12, 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
461
Drugs with new generic filings (by drug name, de-duplicated)
79
Accepted this week, now under review
161

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

461filings, 117 of them generic

By application type

Application typeFilings
Supplement175
New drug134
Generic117
Import21
Unspecified11
Import re-registration3

By drug type

Drug typeFilings
Chemical drug284
Therapeutic biologic94
TCM74
Prophylactic biologic6
Biologic3

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

79 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

261 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
4Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized990
5Hunan Jiu Dian Nuo Na Pharmaceuticals Technology Co., Ltd. romanized880
6Jiangsu Hao Sen Pharma Group Co., Ltd. romanized740
7Bayer Vital GmbH730
8ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.737
9Name not romanized610
10Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized520

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
2026/01/12New 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
2026/01/12New drug · Class 1 注射用华卟啉钠 · No verified English nameCXHS2600017 Shanghai Guang Sheng Pharmaceutical Co., Ltd. romanized
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

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.