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
- 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 type | Filings |
|---|---|
| Supplement | 175 |
| New drug | 134 |
| Generic | 117 |
| Import | 21 |
| Unspecified | 11 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 284 |
| Therapeutic biologic | 94 |
| TCM | 74 |
| Prophylactic biologic | 6 |
| Biologic | 3 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Finerenone Tablets | 5 | 3 | 69 |
| 2 | Oseltamivir Phosphate Capsules | 4 | 2 | 39 |
| 3 | Azilsartan Medoxomil Potassium Tablets | 4 | 2 | 35 |
| 4 | Brivaracetam Tablets | 4 | 1 | 19 |
| 5 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 6 | Mometasone Furoate Cream | 3 | 1 | 16 |
| 7 | Levonorgestrel Tablets | 2 | 2 | 5 |
| 8 | Estradiol Valerate Tablets | 2 | 2 | 7 |
| 9 | Relugolix Tablets | 2 | 2 | 2 |
| 10 | Ertugliflozin Tablets | 2 | 2 | 13 |
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) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Gan Li Pharma Shandong Co., Ltd. romanized | 17 | 1 | 0 |
| 2 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 13 | 2 | 0 |
| 3 | Eli Lilly Nederland B.V. | 12 | 1 | 0 |
| 4 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 5 | Hunan Jiu Dian Nuo Na Pharmaceuticals Technology Co., Ltd. romanized | 8 | 8 | 0 |
| 6 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 7 | 4 | 0 |
| 7 | Bayer Vital GmbH | 7 | 3 | 0 |
| 8 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 7 | 3 | 7 |
| 9 | Name not romanized | 6 | 1 | 0 |
| 10 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 5 | 2 | 0 |
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
| Accepted | Drug | Applicants |
|---|---|---|
| 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.
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