药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/02/23 – 2021/03/01
- New acceptances this week
- 225
- Drugs with new generic filings (by drug name, de-duplicated)
- 24
- 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
225filings, 31 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 98 |
| New drug | 45 |
| Generic | 31 |
| Import | 22 |
| Unspecified | 19 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 169 |
| 治疗用生物制品 | 40 |
| 预防用生物制品 | 10 |
| Biologic | 4 |
| TCM | 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
24 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 托拉塞米注射液 | 3 | 2 | 1 |
| 2 | 奥氮平口崩片 | 2 | 1 | 0 |
| 3 | 富马酸喹硫平缓释片 | 2 | 1 | 0 |
| 4 | 普瑞巴林胶囊 | 2 | 1 | 12 |
| 5 | 盐酸右美托咪定氯化钠注射液 | 2 | 1 | 1 |
| 6 | 色甘酸钠颗粒 | 2 | 1 | 0 |
| 7 | 丙酸氟替卡松吸入粉雾剂 | 1 | 1 | 1 |
| 8 | 丹曲林钠胶囊 | 1 | 1 | 0 |
| 9 | 吸入用复方异丙托溴铵溶液 | 1 | 1 | 4 |
| 10 | 呋塞米注射液 | 1 | 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
130 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 7 | 2 | 0 |
| 2 | 正大天晴药业集团股份有限公司 | 6 | 3 | 0 |
| 3 | 江苏恒瑞医药股份有限公司 | 6 | 3 | 0 |
| 4 | Bayer Inc. | 6 | 1 | 0 |
| 5 | 江苏奥赛康药业有限公司 | 5 | 3 | 2 |
| 6 | 齐鲁制药（海南）有限公司 | 4 | 2 | 0 |
| 7 | Fertin Pharma A/S | 4 | 1 | 0 |
| 8 | GlaxoSmithKline Biologicals SA | 4 | 1 | 0 |
| 9 | NAPP PHARMACEUTICALS LIMITED | 4 | 1 | 0 |
| 10 | Novo Nordisk A/S | 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
77 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/03/01Generic · Class 3 | 奥美沙坦酯氨氯地平片CYHS2101010 | 吉林省德商药业股份有限公司 |
| 2021/02/27Import · Class 1 | 注射用E6201JXHL2100064 | JS INNOPHARM LIMITED |
| 2021/02/27Generic · Class 3 | 福多司坦口服溶液CYHS2100241 | 西洲医药科技（浙江）有限公司; 浙江北生药业汉生制药有限公司 |
| 2021/02/27New drug · Class 3.3 | LY01015注射液CXSL2100076 | 山东博安生物技术股份有限公司 |
| 2021/02/27New drug · Class 3.3 | LY01015注射液CXSL2100075 | 山东博安生物技术股份有限公司 |
| 2021/02/27New drug · Class 3.4 | 托珠单抗注射液CXSL2100074 | 百奥泰生物制药股份有限公司 |
| 2021/02/27New drug · Class 1 | AK117注射液CXSL2100064 | 中山康方生物医药有限公司 |
| 2021/02/27New drug · Class 1 | 注射用重组人源化抗BCMA/CD3双特异性抗体CXSL2100063 | 山东新时代药业有限公司 |
| 2021/02/27New drug · Class 1 | LP-118片CXHL2100148 | 广州麓鹏制药有限公司 |
| 2021/02/27New drug · Class 1 | LP-118片CXHL2100147 | 广州麓鹏制药有限公司 |
| 2021/02/27New drug · Class 1 | ICP-332片CXHL2100146 | 广州诺诚健华医药科技有限公司 |
| 2021/02/27New drug · Class 1 | ICP-332片CXHL2100145 | 广州诺诚健华医药科技有限公司 |
| 2021/02/27New drug · Class 1 | ICP-332片CXHL2100144 | 广州诺诚健华医药科技有限公司 |
| 2021/02/27New drug · Class 1 | HS-10365胶囊CXHL2100143 | 江苏豪森药业集团有限公司 |
| 2021/02/27New drug · Class 1 | HS-10365胶囊CXHL2100142 | 江苏豪森药业集团有限公司 |
| 2021/02/27New drug · Class 1 | JAB-3312胶囊CXHL2100141 | 北京加科思新药研发有限公司 |
| 2021/02/27New drug · Class 1 | JAB-3312胶囊CXHL2100140 | 北京加科思新药研发有限公司 |
| 2021/02/26Import · Class 1 | Mim8JXSL2100032 | Novo Nordisk A/S |
| 2021/02/26Import · Class 1 | Mim8JXSL2100031 | Novo Nordisk A/S |
| 2021/02/26Import · Class 1 | ALG-000184片JXHL2100057 | Aligos Therapeutics Inc. |
| 2021/02/26Import · Class 1 | ALG-000184片JXHL2100056 | Aligos Therapeutics Inc. |
| 2021/02/26Import · Class 1 | ALG-000184片JXHL2100055 | Aligos Therapeutics Inc. |
| 2021/02/26New drug · Class 3.3 | 门冬胰岛素注射液CXSS2100025 | 宜昌东阳光长江药业股份有限公司 |
| 2021/02/26New drug · Class 1 | 重组抗PD-L1和TGF-β双特异性抗体注射液CXSL2100073 | 武汉友芝友生物制药有限公司 |
| 2021/02/26New drug · Class 1.2 | 重组三价轮状病毒亚单位疫苗CXSL2100072 | 上海迈科康生物科技有限公司; 成都迈科康生物科技有限公司 |
| 2021/02/26New drug · Class 1 | HRS8807片CXHL2100139 | 上海恒瑞医药有限公司 |
| 2021/02/26New drug · Class 1 | HRS8807片CXHL2100138 | 上海恒瑞医药有限公司 |
| 2021/02/25Import · Class 3.1 | 双价人乳头瘤病毒吸附疫苗JXSS2100018 | GlaxoSmithKline Biologicals S.A.; GlaxoSmithKline Biologicals SA |
| 2021/02/25Import · Class 3.1 | 双价人乳头瘤病毒吸附疫苗JXSS2100017 | GlaxoSmithKline Biologicals S.A.; GlaxoSmithKline Biologicals SA |
| 2021/02/25Import · Class 1 | Mim8JXSL2100034 | Novo Nordisk A/S |
47 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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