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
- 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 type | Filings |
|---|---|
| Supplement | 193 |
| New drug | 113 |
| Generic | 110 |
| Import | 12 |
| Unspecified | 10 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 258 |
| TCM | 94 |
| Therapeutic biologic | 78 |
| Biologic | 5 |
| Prophylactic biologic | 4 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Finerenone Tablets | 4 | 3 | 69 |
| 2 | Brexpiprazole Tablets | 4 | 2 | 31 |
| 3 | Brivaracetam Tablets | 4 | 1 | 19 |
| 4 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) | 3 | 2 | 15 |
| 5 | Mometasone Furoate Cream | 3 | 1 | 16 |
| 6 | Upadacitinib Sustained-release Tablets | 2 | 2 | 40 |
| 7 | Levonorgestrel Tablets | 2 | 2 | 5 |
| 8 | Mupirocin Ointment | 2 | 2 | 30 |
| 9 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets(III) | 2 | 2 | 10 |
| 10 | Calcitonin Salmon Injection | 2 | 2 | 5 |
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) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 13 | 2 | 0 |
| 2 | Nei Menggu Da Tang Pharma Co., Ltd. romanized | 12 | 12 | 0 |
| 3 | Sichuan Tian De Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 5 | Gan Li Pharma Shandong Co., Ltd. romanized | 9 | 1 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 8 | 2 | 0 |
| 7 | Janssen-Cilag International NV | 8 | 1 | 0 |
| 8 | Guangdong Wan Nian Qing Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 9 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 6 | 2 | 6 |
| 10 | Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized | 6 | 1 | 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
149 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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.
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.