药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/11/23 – 2021/11/29
- New acceptances this week
- 241
- Drugs with new generic filings (by drug name, de-duplicated)
- 27
- 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
241filings, 38 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 125 |
| Generic | 38 |
| New drug | 35 |
| Import | 28 |
| Unspecified | 12 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 167 |
| 治疗用生物制品 | 38 |
| TCM | 31 |
| 预防用生物制品 | 3 |
| 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
27 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 替莫唑胺胶囊 | 3 | 1 | 0 |
| 2 | 盐酸右美托咪定氯化钠注射液 | 3 | 1 | 1 |
| 3 | 利伐沙班片 | 2 | 2 | 3 |
| 4 | 盐酸莫西沙星滴眼液 | 2 | 2 | 5 |
| 5 | 他达拉非片 | 2 | 1 | 23 |
| 6 | 奥贝胆酸片 | 2 | 1 | 0 |
| 7 | 氟尿嘧啶注射液 | 2 | 1 | 6 |
| 8 | 盐酸右美托咪定注射液 | 2 | 1 | 0 |
| 9 | 艾司奥美拉唑镁肠溶干混悬剂 | 2 | 1 | 4 |
| 10 | 卡格列净二甲双胍缓释片 | 1 | 1 | 5 |
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 | 武汉爱民制药股份有限公司 | 18 | 16 | 0 |
| 2 | 恒昌(广州)新药研究有限公司 | 10 | 10 | 0 |
| 3 | 海南涛生医药科技研究院有限公司 | 7 | 4 | 0 |
| 4 | 吉林敖东延边药业股份有限公司 | 5 | 4 | 0 |
| 5 | 四川国瑞药业有限责任公司 | 5 | 2 | 5 |
| 6 | F. Hoffmann-La Roche Ltd | 4 | 3 | 0 |
| 7 | ViiV Healthcare BV | 4 | 3 | 0 |
| 8 | 四川汇宇制药股份有限公司 | 4 | 3 | 4 |
| 9 | AstraZeneca AB | 4 | 2 | 0 |
| 10 | Pfizer Europe MA EEIG | 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
70 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/11/29Import · Class 1 | BAY 2586116鼻喷雾剂JXHL2101259 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2021/11/29Import · Class 1 | BAY 2586116鼻喷雾剂JXHL2101258 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2021/11/29Import · Class 1 | BAY 2586116鼻喷雾剂JXHL2101257 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2021/11/29Generic · Class 3 | 吸入用盐酸丙卡特罗溶液CYHS2102099 | 南京华盖制药有限公司 |
| 2021/11/29Generic · Class 3 | 注射用盐酸罗沙替丁醋酸酯CYHS2102095 | 扬子江药业集团南京海陵药业有限公司; 扬子江药业集团江苏紫龙药业有限公司 |
| 2021/11/29Generic · Class 3 | 艾司奥美拉唑镁肠溶干混悬剂CYHS2102094 | 成都苑东生物制药股份有限公司 |
| 2021/11/29Generic · Class 3 | 艾司奥美拉唑镁肠溶干混悬剂CYHS2102093 | 成都苑东生物制药股份有限公司 |
| 2021/11/29New drug · Class 3.2 | 注射用重组人甲状旁腺素(1-84)CXSL2101455 | 四川泸州步长生物制药有限公司 |
| 2021/11/29New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液CXSL2101454 | 江苏康宁杰瑞生物制药有限公司 |
| 2021/11/29New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液CXSL2101453 | 江苏康宁杰瑞生物制药有限公司 |
| 2021/11/29New drug · Class 1 | CAB-ROR2-ADC注射剂CXSL2101439 | 凯博斯(上海)生物医药有限公司 |
| 2021/11/29New drug · Class 1 | HSK31858片CXHL2101696 | 海思科医药集团股份有限公司 |
| 2021/11/29New drug · Class 1 | HSK31858片CXHL2101695 | 海思科医药集团股份有限公司 |
| 2021/11/29New drug · Class 1 | JMKX000189注射液CXHL2101694 | 上海济煜医药科技有限公司; 浙江杭煜制药有限公司 |
| 2021/11/29New drug · Class 1 | 注射用PMS-001CXHL2101693 | 青岛普美圣医药科技有限公司 |
| 2021/11/29New drug · Class 1 | TLL-018片CXHL2101692 | 杭州高光制药有限公司 |
| 2021/11/29New drug · Class 1 | BGT-002片CXHL2101691 | 博骥源(上海)生物医药有限公司 |
| 2021/11/29New drug · Class 1 | BGT-002片CXHL2101690 | 博骥源(上海)生物医药有限公司 |
| 2021/11/26Import · Class 2.2 | 帕博利珠单抗注射液JXSS2101033 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2021/11/26Import · Class 1 | HBM9161(HL161BKN)注射液JXSL2101139 | Harbour BioMed Therapeutics Limited; 和铂医药(苏州)有限公司 |
| 2021/11/26Import · Class 2.4 | 甲磺酸奥希替尼片JXHL2101261 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2021/11/26Import · Class 2.4 | 甲磺酸奥希替尼片JXHL2101260 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2021/11/26New drug · Class 1.2 | 丹酚酸ACXZL2101035 | 江西青峰药业有限公司 |
| 2021/11/26New drug · Class 1 | SI-B003双特异性抗体注射液CXSL2101452 | 四川百利药业有限责任公司; 成都百利多特生物药业有限责任公司 |
| 2021/11/26New drug · Class 1 | SI-B003双特异性抗体注射液CXSL2101451 | 四川百利药业有限责任公司; 成都百利多特生物药业有限责任公司 |
| 2021/11/26New drug · Class 1 | KN052注射液CXSL2101450 | 江苏康宁杰瑞生物制药有限公司 |
| 2021/11/26New drug · Class 1 | PM1022 注射液CXSL2101447 | 普米斯生物技术(珠海)有限公司 |
| 2021/11/26New drug · Class 1 | 重组抗IL-4Rα单域抗体雾化液(毕赤酵母)CXSL2101446 | 上海洛启生物医药技术有限公司 |
| 2021/11/26New drug · Class 1 | ES002023注射液CXSL2101445 | 科望(苏州)生物医药科技有限公司 |
| 2021/11/26New drug · Class 1 | 硝酮嗪肠溶片CXHL2101688 | 广州喜鹊医药有限公司 |
40 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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