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
- 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 type | Filings |
|---|---|
| Supplement | 169 |
| New drug | 84 |
| Generic | 81 |
| Unspecified | 10 |
| Import | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 210 |
| TCM | 79 |
| Therapeutic biologic | 56 |
| 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
61 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Pregabalin Capsules | 3 | 1 | 12 |
| 2 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 3 | Levonorgestrel Tablets | 2 | 2 | 5 |
| 4 | Mupirocin Ointment | 2 | 2 | 30 |
| 5 | 依伏卡塞片 · No verified English name | 2 | 1 | 9 |
| 6 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 7 | 地氯雷他定口服溶液 · No verified English name | 2 | 1 | 26 |
| 8 | Perindopril and Indapamide Tablets | 2 | 1 | 3 |
| 9 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 10 | Bisoprolol Fumarate Tablets | 2 | 1 | 6 |
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) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Da Tang Pharma Co., Ltd. romanized | 12 | 12 | 0 |
| 2 | Sichuan Tian De Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Gan Li Pharma Shandong Co., Ltd. romanized | 9 | 1 | 0 |
| 4 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 8 | 2 | 0 |
| 5 | Janssen-Cilag International NV | 8 | 1 | 0 |
| 6 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 7 | Guangdong Wan Nian Qing Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 8 | Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Hunan Jiudian Pharmaceutical Co., Ltd | 4 | 4 | 2 |
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
| Accepted | Drug | Applicants |
|---|---|---|
| 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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