药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/07/06 – 2021/07/12
- New acceptances this week
- 271
- Drugs with new generic filings (by drug name, de-duplicated)
- 26
- Accepted this week, now under review
- 0
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
271filings, 37 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 156 |
| New drug | 43 |
| Generic | 37 |
| Import | 30 |
| Import re-registration | 4 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 208 |
| TCM | 35 |
| 治疗用生物制品 | 26 |
| 体外诊断试剂 | 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
26 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用头孢曲松钠 | 3 | 1 | 13 |
| 2 | 乙酰半胱氨酸颗粒 | 2 | 2 | 4 |
| 3 | 他克莫司软膏 | 2 | 2 | 8 |
| 4 | 培哚普利叔丁胺片 | 2 | 1 | 5 |
| 5 | 左乙拉西坦片 | 2 | 1 | 6 |
| 6 | 注射用头孢他啶 | 2 | 1 | 4 |
| 7 | 盐酸丙卡特罗口服溶液 | 2 | 1 | 12 |
| 8 | 米诺地尔外用溶液 | 2 | 1 | 0 |
| 9 | 舒更葡糖钠注射液 | 2 | 1 | 6 |
| 10 | 苯磺顺阿曲库铵注射液 | 2 | 1 | 4 |
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
135 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 海南久常制药有限公司 | 42 | 28 | 0 |
| 2 | 扬子江药业集团江苏龙凤堂中药有限公司 | 17 | 16 | 0 |
| 3 | AstraZeneca AB | 8 | 3 | 0 |
| 4 | Novartis Pharma Schweiz AG | 6 | 3 | 0 |
| 5 | 山东润泽制药有限公司 | 6 | 1 | 0 |
| 6 | 广西古方药业有限公司 | 5 | 4 | 0 |
| 7 | 湖南恒生制药股份有限公司 | 5 | 2 | 5 |
| 8 | 佛山德芮可制药有限公司 | 5 | 1 | 0 |
| 9 | Novartis Europharm Ltd. | 4 | 2 | 0 |
| 10 | McNeil Sweden AB | 4 | 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
76 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/07/12Import · Class 1 | Mobocertinib胶囊JXHS2101024 | Takeda Pharmaceuticals U.S.A. Inc.; Xcelience LLC; Takeda (China) International Trading Co. Ltd |
| 2021/07/12Generic · Class 3 | 奥美沙坦酯氨氯地平片CYHS2101433 | 安庆回音必制药股份有限公司; 回音必集团抚州制药有限公司 |
| 2021/07/12Generic · Class 3 | 地氯雷他定口服溶液CYHS2101428 | 扬子江药业集团有限公司; 扬子江药业集团江苏制药股份有限公司 |
| 2021/07/12New drug · Class 1 | PM8001注射液CXSL2101188 | 普米斯生物技术（珠海）有限公司 |
| 2021/07/12New drug · Class 1 | 重组人源化单克隆抗体MIL62注射液CXSL2101187 | 北京天广实生物技术股份有限公司 |
| 2021/07/12New drug · Class 1 | IBI389CXSL2101186 | 信达生物制药（苏州）有限公司 |
| 2021/07/12New drug · Class 1 | IBI322CXSL2101183 | 信达生物制药（苏州）有限公司 |
| 2021/07/12New drug · Class 3.3 | 注射用重组抗IgE人源化单克隆抗体CXSL2101178 | 上海泰因生物技术有限公司 |
| 2021/07/12New drug · Class 2.2 | HR19024注射液CXHL2101287 | 上海恒瑞医药有限公司 |
| 2021/07/12New drug · Class 1 | ST-1703片CXHL2101286 | 北京赛特明强医药科技有限公司 |
| 2021/07/12New drug · Class 1 | ST-1703片CXHL2101285 | 北京赛特明强医药科技有限公司 |
| 2021/07/12New drug · Class 1 | SHR7280片CXHL2101284 | 江苏恒瑞医药股份有限公司 |
| 2021/07/12New drug · Class 1 | SHR7280片CXHL2101283 | 江苏恒瑞医药股份有限公司 |
| 2021/07/12New drug · Class 2.2 | 来那度胺缓释片CXHL2101282 | 广州帝奇医药技术有限公司 |
| 2021/07/12New drug · Class 2.2 | 来那度胺缓释片CXHL2101281 | 广州帝奇医药技术有限公司 |
| 2021/07/12New drug · Class 1 | ABSK-011胶囊CXHL2101280 | 上海和誉生物医药科技有限公司 |
| 2021/07/12New drug · Class 1 | ABSK-011胶囊CXHL2101279 | 上海和誉生物医药科技有限公司 |
| 2021/07/09Import · Class 2.4 | Copanlisib 注射用冻干制剂JXHS2101025 | Bayer HealthCare Pharmaceuticals Inc.; Bayer AG; Bayer Healthcare Company Ltd. |
| 2021/07/09Import · Class 2.4 | 曲美替尼片JXHL2101131 | Novartis Europharm Ltd.; Beijing Novartis Pharmaceutical Co. Ltd. |
| 2021/07/09Import · Class 2.4 | 曲美替尼片JXHL2101130 | Novartis Europharm Ltd.; Beijing Novartis Pharmaceutical Co. Ltd. |
| 2021/07/09Import · Class 2.4 | 甲磺酸达拉非尼胶囊JXHL2101129 | Novartis Europharm Ltd.; Beijing Novartis Pharmaceutical Co. Ltd. |
| 2021/07/09Import · Class 2.4 | 甲磺酸达拉非尼胶囊JXHL2101128 | Novartis Europharm Ltd.; Beijing Novartis Pharmaceutical Co. Ltd. |
| 2021/07/09Import · Class 1 | BAY 2586116鼻喷雾剂JXHL2101127 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2021/07/09Generic · Class 3 | 盐酸奥普力农注射液CYHS2101425 | 德全药品（江苏）股份有限公司 |
| 2021/07/09Generic · Class 3 | ω-3鱼油中长链脂肪乳/氨基酸（16）/葡萄糖（16%）注射液CYHL2101018 | 四川科伦药业股份有限公司 |
| 2021/07/09New drug · Class 1 | C-4-29细胞制剂CXSL2101182 | 重庆精准生物技术有限公司 |
| 2021/07/09New drug · Class 1 | AK112注射液CXSL2101177 | 中山康方生物医药有限公司 |
| 2021/07/09New drug · Class 1 | TNP-2092胶囊CXHL2101278 | 丹诺医药（苏州）有限公司 |
| 2021/07/09New drug · Class 2.2 | 阿哌沙班多释片CXHL2101277 | 泰州越洋医药开发有限公司 |
| 2021/07/09New drug · Class 1 | HMPL-453酒石酸盐片CXHL2101276 | 和记黄埔医药（上海）有限公司 |
46 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.