药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/07/05 – 2022/07/11
- New acceptances this week
- 240
- Drugs with new generic filings (by drug name, de-duplicated)
- 34
- Accepted this week, now under review
- 1
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
240filings, 45 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 108 |
| Generic | 45 |
| New drug | 33 |
| Import | 25 |
| Import re-registration | 17 |
| Unspecified | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 177 |
| 治疗用生物制品 | 34 |
| TCM | 21 |
| Biologic | 5 |
| 预防用生物制品 | 3 |
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
34 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 利伐沙班片 | 3 | 1 | 3 |
| 2 | 盐酸氢吗啡酮缓释片 | 3 | 1 | 0 |
| 3 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 51 |
| 4 | 吲哚布芬片 | 2 | 1 | 7 |
| 5 | 奥硝唑注射液 | 2 | 1 | 0 |
| 6 | 盐酸乌拉地尔注射液 | 2 | 1 | 5 |
| 7 | 草酸艾司西酞普兰片 | 2 | 1 | 6 |
| 8 | 葡萄糖酸钙氯化钠注射液 | 2 | 1 | 5 |
| 9 | 酮咯酸氨丁三醇注射液 | 2 | 1 | 4 |
| 10 | 低钙腹膜透析液(乳酸盐-G1.5%) | 1 | 1 | 3 |
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
144 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 哈药集团世一堂制药厂 | 8 | 8 | 0 |
| 2 | 宜昌人福药业有限责任公司 | 7 | 3 | 3 |
| 3 | 石家庄四药有限公司 | 6 | 4 | 3 |
| 4 | Novo Nordisk A/S | 5 | 4 | 0 |
| 5 | LES LABORATOIRES SERVIER | 5 | 3 | 0 |
| 6 | AstraZeneca UK Limited | 5 | 2 | 0 |
| 7 | CSL Behring GmbH | 5 | 1 | 0 |
| 8 | Pfizer Europe MA EEIG | 4 | 3 | 0 |
| 9 | F. Hoffmann-La Roche Ltd | 4 | 2 | 0 |
| 10 | 上海海雁医药科技有限公司 | 4 | 2 | 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
69 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/07/11Import · Class 3.1 | 注射用重组人凝血因子IX-白蛋白融合蛋白JXSL2200118 | CSL Behring GmbH; PAREXEL CHINA CO. LTD |
| 2022/07/11Import · Class 3.1 | 注射用重组人凝血因子IX-白蛋白融合蛋白JXSL2200117 | CSL Behring GmbH; PAREXEL CHINA CO. LTD |
| 2022/07/11Import · Class 3.1 | 注射用重组人凝血因子IX-白蛋白融合蛋白JXSL2200116 | CSL Behring GmbH; PAREXEL CHINA CO. LTD |
| 2022/07/11Import · Class 3.1 | 注射用重组人凝血因子IX-白蛋白融合蛋白JXSL2200115 | CSL Behring GmbH; PAREXEL CHINA CO. LTD |
| 2022/07/11Import · Class 3.1 | 注射用重组人凝血因子IX-白蛋白融合蛋白JXSL2200114 | CSL Behring GmbH; PAREXEL CHINA CO. LTD |
| 2022/07/11Generic · Class 3 | 盐酸氢吗啡酮缓释片CYHS2201047 | 宜昌人福药业有限责任公司 |
| 2022/07/11Generic · Class 3 | 盐酸氢吗啡酮缓释片CYHS2201046 | 宜昌人福药业有限责任公司 |
| 2022/07/11Generic · Class 3 | 盐酸氢吗啡酮缓释片CYHS2201045 | 宜昌人福药业有限责任公司 |
| 2022/07/11Generic · Class 3 | 醋酸特利加压素注射液CYHS2201042 | 杭州沐源生物医药科技有限公司; 山西威奇达光明制药有限公司 |
| 2022/07/11Generic · Class 3 | 葡萄糖酸钙氯化钠注射液CYHS2201041 | 海南紫程众投生物科技有限公司; 浙江国镜药业有限公司 |
| 2022/07/11Generic · Class 3 | 葡萄糖酸钙氯化钠注射液CYHS2201040 | 海南紫程众投生物科技有限公司; 浙江国镜药业有限公司 |
| 2022/07/11Generic · Class 3 | 氟[18F]比他班注射液CYHS2201037 | 北京先通国际医药科技股份有限公司; 天津原子高科同位素医药有限公司 |
| 2022/07/11Generic · Class 3 | 糠酸莫米松乳膏CYHS2201026 | 福元药业有限公司 |
| 2022/07/11Generic · Class 3 | 普瑞巴林缓释片CYHL2200057 | 齐鲁制药有限公司 |
| 2022/07/11Generic · Class 3 | 盐酸溴己新雾化吸入溶液CYHL2200056 | 海南葫芦娃药业集团股份有限公司 |
| 2022/07/11New drug · Class 3.3 | 注射用依那西普CXSS2200063 | 齐鲁制药有限公司 |
| 2022/07/11New drug · Class 1 | BC008-1A注射液CXSL2200315 | 四川泸州步长生物制药有限公司 |
| 2022/07/11New drug · Class 1 | PM1009注射液CXSL2200312 | 普米斯生物技术(珠海)有限公司 |
| 2022/07/11New drug · Class 1 | 注射用KH617CXHL2200491 | 四川弘合生物科技有限公司 |
| 2022/07/08Generic · Class 3 | 奥硝唑注射液CYHS2201034 | 四川新斯顿制药股份有限公司 |
| 2022/07/08Generic · Class 3 | 奥硝唑注射液CYHS2201033 | 四川新斯顿制药股份有限公司 |
| 2022/07/08Generic · Class 3 | 盐酸溴己新注射液CYHS2201032 | 合肥国药诺和药业有限公司; 国药集团国瑞药业有限公司 |
| 2022/07/08Generic · Class 3 | 盐酸阿比多尔片CYHS2201031 | 石家庄四药有限公司 |
| 2022/07/08New drug · Class 1 | SHR8554注射液CXHS2200038 | 江苏恒瑞医药股份有限公司 |
| 2022/07/08New drug · Class 1 | SHR8554注射液CXHS2200037 | 江苏恒瑞医药股份有限公司 |
| 2022/07/07Import · Class 2.2 | 萨特利珠单抗注射液JXSL2200113 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2022/07/07Import · Class 2.2 | 萨特利珠单抗注射液JXSL2200112 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2022/07/07Import · Class 1 | Modakafusp Alfa注射液(TAK-573)JXSL2200111 | Takeda Development Center Americas Inc.; Takeda(China) International Trading Co. Ltd |
| 2022/07/07Import · Class 2.2 | 帕博利珠单抗注射液JXSL2200110 | Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd. |
| 2022/07/07Import · Class 1 | MK-4830注射液JXSL2200109 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
39 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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