药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/11/16 – 2021/11/22
- New acceptances this week
- 232
- 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
232filings, 38 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 117 |
| Generic | 38 |
| New drug | 37 |
| Import | 22 |
| Import re-registration | 11 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 175 |
| 治疗用生物制品 | 27 |
| TCM | 25 |
| Biologic | 3 |
| 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
26 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿普米司特片 | 3 | 1 | 3 |
| 2 | 枸橼酸西地那非口崩片 | 2 | 2 | 8 |
| 3 | 丙戊酸钠注射用浓溶液 | 2 | 1 | 0 |
| 4 | 奥扎格雷钠注射液 | 2 | 1 | 3 |
| 5 | 奥贝胆酸片 | 2 | 1 | 0 |
| 6 | 富马酸比索洛尔片 | 2 | 1 | 6 |
| 7 | 托伐普坦片 | 2 | 1 | 0 |
| 8 | 枸橼酸坦度螺酮片 | 2 | 1 | 2 |
| 9 | 氨茶碱注射液 | 2 | 1 | 3 |
| 10 | 注射用阿糖胞苷 | 2 | 1 | 2 |
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
140 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 恒昌(广州)新药研究有限公司 | 9 | 9 | 0 |
| 2 | Actelion Pharmaceuticals Ltd | 8 | 1 | 0 |
| 3 | 大连天山药业有限公司 | 6 | 6 | 0 |
| 4 | Upjohn Manufacturing Ireland Unlimited | 6 | 1 | 0 |
| 5 | 石家庄御和堂药业股份有限公司 | 4 | 4 | 0 |
| 6 | 北京加科思新药研发有限公司 | 4 | 2 | 0 |
| 7 | Upjohn US 2 LLC | 4 | 1 | 0 |
| 8 | 海南卫康制药(潜山)有限公司 | 4 | 1 | 0 |
| 9 | 正大天晴药业集团股份有限公司 | 3 | 2 | 0 |
| 10 | 济川药业集团有限公司 | 3 | 2 | 3 |
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
64 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/11/22Import · Class 3.1 | 赖脯胰岛素注射液JXSS2101032 | Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/11/22Import · Class 3.1 | 赖脯胰岛素注射液JXSS2101031 | Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/11/22Import · Class 2.2 | 帕博利珠单抗注射液JXSL2101135 | Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd. |
| 2021/11/22Import · Class 2.4 | 盐酸阿来替尼胶囊JXHL2101246 | F.Hoffmann-La Roche Ltd; Roche(China) Holding Ltd. |
| 2021/11/22Import · Class 2.4 | 盐酸阿来替尼胶囊JXHL2101245 | F.Hoffmann-La Roche Ltd; Roche(China) Holding Ltd. |
| 2021/11/22Generic · Class 3 | 缩宫素注射液CYHS2102059 | 远大生命科学(武汉)有限公司 |
| 2021/11/22New drug · Class 1 | 重组人源化抗PD-1单克隆抗体注射液CXSL2101434 | 神州细胞工程有限公司 |
| 2021/11/22New drug · Class 2.2 | 重组人源化抗VEGF单克隆抗体注射液CXSL2101433 | 神州细胞工程有限公司 |
| 2021/11/22New drug · Class 1 | 人肌母细胞注射液CXSL2101432 | 罗盖肌母细胞医学研究院武汉有限公司 |
| 2021/11/22New drug · Class 2.2 | 注射用全氟丙烷人血白蛋白微球CXSL2101431 | 厦门力卓药业有限公司 |
| 2021/11/22New drug · Class 1 | AK115注射液CXSL2101430 | 中山康方生物医药有限公司 |
| 2021/11/22New drug · Class 1 | AK115注射液CXSL2101429 | 中山康方生物医药有限公司 |
| 2021/11/22New drug · Class 1 | 注射用IAP0971CXSL2101428 | 盛禾(中国)生物制药有限公司 |
| 2021/11/22New drug · Class 1 | SHR7280片CXHL2101679 | 江苏恒瑞医药股份有限公司 |
| 2021/11/22New drug · Class 1 | SHR7280片CXHL2101678 | 江苏恒瑞医药股份有限公司 |
| 2021/11/22New drug · Class 1 | 注射用SYHA1908CXHL2101677 | 石药集团中奇制药技术(石家庄)有限公司 |
| 2021/11/22New drug · Class 1 | HZ010注射液CXHL2101676 | 浙江和泽医药科技股份有限公司 |
| 2021/11/19Generic · Class 3 | 己酮可可碱缓释片CYHS2102028 | 石家庄四药有限公司 |
| 2021/11/19New drug · Class 3.2 | 人抗凝血酶ⅢCXSS2101053 | 山东泰邦生物制品有限公司 |
| 2021/11/19New drug · Class 1 | 泰特利单抗注射液CXSS2101052 | 四川科伦博泰生物医药股份有限公司 |
| 2021/11/19New drug · Class 1 | 重组人源化抗BTLA单克隆抗体注射液CXSL2101427 | 上海君实生物医药科技股份有限公司 |
| 2021/11/19New drug · Class 1 | FZJ-003胶囊CXHL2101675 | 上海复旦张江生物医药股份有限公司 |
| 2021/11/19New drug · Class 1 | BPI-442096片CXHL2101669 | 贝达药业股份有限公司 |
| 2021/11/19New drug · Class 1 | BPI-442096片CXHL2101668 | 贝达药业股份有限公司 |
| 2021/11/19New drug · Class 1 | HS301片CXHL2101667 | 瀚晖制药有限公司 |
| 2021/11/19New drug · Class 1 | HS301片CXHL2101666 | 瀚晖制药有限公司 |
| 2021/11/18Import · Class 1 | 司柏索利单抗注射液JXSS2101030 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/11/18Import · Class 1 | 注射用Dapirolizumab Pegol单抗JXSL2101134 | UCB Biopharma SRL; UCB trading (Shanghai) Co. Ltd |
| 2021/11/18Generic · Class 3 | 氨茶碱注射液CYHS2102047 | 山东玉满坤生物科技有限公司; 山东希尔康泰药业有限公司 |
| 2021/11/18Generic · Class 3 | 氨茶碱注射液CYHS2102046 | 山东玉满坤生物科技有限公司; 山东希尔康泰药业有限公司 |
34 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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