药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
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
- 563
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.
Drug and company names link to detail pages; sign in to view them.
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 |
| 治疗用生物制品 | 117 |
| Biologic | 7 |
| 预防用生物制品 | 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 | 磷酸芦可替尼片 | 4 | 1 | 27 |
| 2 | 艾托格列净片 | 3 | 3 | 11 |
| 3 | 富马酸依美斯汀缓释胶囊 | 3 | 2 | 11 |
| 4 | 司美格鲁肽注射液 | 3 | 1 | 87 |
| 5 | 盐酸金刚烷胺口服溶液 | 3 | 1 | 3 |
| 6 | 磷酸奥司他韦胶囊 | 3 | 1 | 42 |
| 7 | 莫匹罗星软膏 | 3 | 1 | 31 |
| 8 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 52 |
| 9 | 呋喹替尼胶囊 | 2 | 1 | 4 |
| 10 | 氨甲环酸注射液 | 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 | 百济神州（苏州）生物科技有限公司 | 13 | 3 | 0 |
| 2 | 信达生物制药（苏州）有限公司 | 11 | 8 | 0 |
| 3 | 北京同仁堂股份有限公司同仁堂制药厂 | 9 | 6 | 0 |
| 4 | 太极集团重庆桐君阁药厂有限公司 | 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 | 宁康瑞珠生物制药（珠海）有限公司 | 6 | 2 | 0 |
| 9 | 福州海王金象中药制药有限公司 | 6 | 2 | 0 |
| 10 | 济川（上海）医学科技有限公司 | 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 no longer on the under-review list whose last snapshot sighting falls in this week, meaning approved or terminated, to be verified. 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JXSL2600255 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2026/09/21Generic · Class 3 | 对乙酰氨基酚布洛芬片CYHS2602374 | 南京海纳医药科技股份有限公司; 南京海纳制药有限公司 |
| 2026/09/21Generic · Class 3 | 盐酸西替利嗪滴眼液CYHS2602367 | 北京茗泽中和药物研究有限公司; 北京汇恩兰德制药股份有限公司 |
| 2026/09/21Generic · Class 3 | 中性低钙腹膜透析液（碳酸氢盐-G4.25%）CYHS2602365 | 上海长征富民金山制药有限公司 |
| 2026/09/21Generic · Class 3 | 中性腹膜透析液（碳酸氢盐-G4.25%）CYHS2602359 | 上海长征富民金山制药有限公司 |
| 2026/09/21Generic · Class 3 | 琥珀酸曲格列汀片CYHS2602358 | 江苏德源药业股份有限公司 |
| 2026/09/21New drug · Class 1 | YT003注射液CXSL2601045 | 北京永泰生物制品有限公司 |
| 2026/09/21New drug · Class 1 | BT02单克隆抗体注射液CXSL2601044 | 上海柏全生物科技有限公司 |
| 2026/09/21New drug · Class 1 | HS-IT101注射液CXSL2601043 | 青岛中赛伯曼生物科技有限公司 |
| 2026/09/21New drug · Class 1 | 注射用TQB6411CXSL2601042 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2026/09/21New drug · Class 1 | SHR-4506注射液CXSL2601041 | 苏州盛迪亚生物医药有限公司 |
| 2026/09/21New drug · Class 1 | SHR-4461注射液CXSL2601040 | 苏州盛迪亚生物医药有限公司 |
| 2026/09/21New drug · Class 1 | BHV-1400CXSL2601039 | 北京MEDPACE医药科技有限公司 |
| 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CXSL2601038 | 长春百克生物科技股份公司 |
| 2026/09/21New drug · Class 1 | SYH2099胶囊CXHL2601187 | 上海翊石医药科技有限公司 |
| 2026/09/21New drug · Class 1 | SYH2099胶囊CXHL2601186 | 上海翊石医药科技有限公司 |
| 2026/09/21New drug · Class 1 | SYH2099胶囊CXHL2601185 | 上海翊石医药科技有限公司 |
| 2026/09/20Import · Class 1 | PF-08154225注射液JXSL2600254 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/20Import · Class 1 | PF-08154225注射液JXSL2600253 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/20Import · Class 1 | PF-08154225注射液JXSL2600252 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/20Import · Class 1 | PF-08154225注射液JXSL2600251 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/20Import · Class 2.4 | 贝组替凡片JXHS2600114 | MERCK SHARP & DOHME (UK) LIMITED; MSD INTERNATIONAL GMBH; MSD R&D (China) Co. Ltd |
| 2026/09/20Import · Class 1 | DDY391片JXHL2600411 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/09/20Import · Class 1 | DDY391片JXHL2600410 | 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）CYHS2602355 | 重庆希韦医药科技有限公司; 重庆博腾药业有限公司 |
| 2026/09/20Generic · Class 3 | 恩格列净二甲双胍缓释片（Ⅱ）CYHS2602354 | 重庆希韦医药科技有限公司; 重庆博腾药业有限公司 |
| 2026/09/20Generic · Class 3 | 恩格列净二甲双胍缓释片（Ⅲ）CYHS2602353 | 重庆希韦医药科技有限公司; 重庆博腾药业有限公司 |
| 2026/09/20Generic · Class 3 | 铝碳酸镁混悬液CYHS2602348 | 浙江核力欣健药业有限公司 |
| 2026/09/20Generic · Class 3 | 辅酶Q10片CYHS2602347 | 远大医药（仙桃）制药有限公司 |
| 2026/09/20Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2602346 | 河南合智医药科技有限公司; 酒泉大得利制药股份有限公司 |
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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