YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 654 drug applications between 15 September 2026 and 21 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 105, covering 76 drug names.
2026/09/15 – 2026/09/21
- New acceptances this week
- 654
- Drugs with new generic filings (by drug name, de-duplicated)
- 76
- Accepted this week, now under review
- 559
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
654filings, 105 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 352 |
| New drug | 137 |
| Generic | 105 |
| Import | 32 |
| Unspecified | 14 |
| Import re-registration | 14 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 325 |
| TCM | 203 |
| Therapeutic biologic | 117 |
| Biologic | 7 |
| Prophylactic biologic | 2 |
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
76 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ruxolitinib Phosphate Tablets | 4 | 1 | 27 |
| 2 | Ertugliflozin Tablets | 3 | 3 | 13 |
| 3 | Emedastine Difumarate Sustained-release Capsules | 3 | 2 | 11 |
| 4 | 司美格鲁肽注射液 · No verified English name | 3 | 1 | 92 |
| 5 | 盐酸金刚烷胺口服溶液 · No verified English name | 3 | 1 | 3 |
| 6 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 7 | Mupirocin Ointment | 3 | 1 | 30 |
| 8 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 9 | Fruquintinib Capsules | 2 | 1 | 4 |
| 10 | Tranexamic Acid Injection | 2 | 1 | 11 |
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
374 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 13 | 3 | 0 |
| 2 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 11 | 8 | 0 |
| 3 | Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized | 9 | 6 | 0 |
| 4 | Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized | 8 | 7 | 0 |
| 5 | Janssen-Cilag International NV | 8 | 1 | 0 |
| 6 | F. Hoffmann-La Roche Ltd | 7 | 2 | 0 |
| 7 | Novo Nordisk A/S | 6 | 2 | 0 |
| 8 | Ning Kang Rui Zhu Biopharmaceutical (Zhuhai) Co., Ltd. romanized | 6 | 2 | 0 |
| 9 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 10 | Ji Chuan (Shanghai) Yi Xue Technology 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
197 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/21Import · Class 1 | SAR448632注射用粉末 · No verified English nameJXSL2600255 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2026/09/21Generic · Class 3 | Paracetamol and Ibuprofen TabletsCYHS2602374 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2026/09/21Generic · Class 3 | 盐酸西替利嗪滴眼液 · No verified English nameCYHS2602367 | Beijing Ming Ze Zhong He Drug Research Co., Ltd. romanized; Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized |
| 2026/09/21Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G4.25%) · No verified English nameCYHS2602365 | Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2026/09/21Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G4.25%) · No verified English nameCYHS2602359 | Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2026/09/21Generic · Class 3 | Trelagliptin Succinate TabletsCYHS2602358 | Jiangsu Deyuan Pharmaceutical Co.,Ltd. |
| 2026/09/21New drug · Class 1 | YT003注射液 · No verified English nameCXSL2601045 | Beijing Yong Tai Bio Zhi Pin Co., Ltd. romanized |
| 2026/09/21New drug · Class 1 | BT02单克隆抗体注射液 · No verified English nameCXSL2601044 | Shanghai Bai Quan Bio Technology Co., Ltd. romanized |
| 2026/09/21New drug · Class 1 | HS-IT101注射液 · No verified English nameCXSL2601043 | Qingdao Zhong Sai Bo Man Bio Technology Co., Ltd. romanized |
| 2026/09/21New drug · Class 1 | 注射用TQB6411 · No verified English nameCXSL2601042 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2026/09/21New drug · Class 1 | SHR-4506注射液 · No verified English nameCXSL2601041 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/09/21New drug · Class 1 | SHR-4461注射液 · No verified English nameCXSL2601040 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/09/21New drug · Class 1 | BHV-1400 · No verified English nameCXSL2601039 | Beijing MEDPACE Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/21New drug · Class 1 | 重组人源抗呼吸道合胞病毒单克隆抗体注射液组合制剂 · No verified English nameCXSL2601038 | Changchun Bai Ke Bio Technology Shareholding Company romanized |
| 2026/09/21New drug · Class 1 | SYH2099胶囊 · No verified English nameCXHL2601187 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/21New drug · Class 1 | SYH2099胶囊 · No verified English nameCXHL2601186 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/21New drug · Class 1 | SYH2099胶囊 · No verified English nameCXHL2601185 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/20Import · Class 1 | PF-08154225注射液 · No verified English nameJXSL2600254 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/20Import · Class 1 | PF-08154225注射液 · No verified English nameJXSL2600253 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/20Import · Class 1 | PF-08154225注射液 · No verified English nameJXSL2600252 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/20Import · Class 1 | PF-08154225注射液 · No verified English nameJXSL2600251 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/20Import · Class 2.4 | 贝组替凡片 · No verified English nameJXHS2600114 | MERCK SHARP & DOHME (UK) LIMITED; MSD INTERNATIONAL GMBH; MSD R&D (China) Co. Ltd |
| 2026/09/20Import · Class 1 | DDY391片 · No verified English nameJXHL2600411 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/09/20Import · Class 1 | DDY391片 · No verified English nameJXHL2600410 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/09/20Generic · Class 3 | 恩格列净二甲双胍缓释片(Ⅳ) · No verified English nameCYHS2602355 | Chongqing Xi Wei Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized |
| 2026/09/20Generic · Class 3 | 恩格列净二甲双胍缓释片(Ⅱ) · No verified English nameCYHS2602354 | Chongqing Xi Wei Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized |
| 2026/09/20Generic · Class 3 | 恩格列净二甲双胍缓释片(Ⅲ) · No verified English nameCYHS2602353 | Chongqing Xi Wei Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized |
| 2026/09/20Generic · Class 3 | Hydrotalcite SuspensionCYHS2602348 | Zhejiang He Li Xin Jian Pharma Co., Ltd. romanized |
| 2026/09/20Generic · Class 3 | 辅酶Q10片 · No verified English nameCYHS2602347 | Yuan Da Pharmaceuticals (Xian Tao) Pharmaceutical Co., Ltd. romanized |
| 2026/09/20Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2602346 | Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized |
167 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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