药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/10/25 – 2022/10/31
- New acceptances this week
- 224
- Drugs with new generic filings (by drug name, de-duplicated)
- 40
- 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
224filings, 48 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 115 |
| Generic | 48 |
| New drug | 27 |
| Unspecified | 16 |
| Import | 14 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 174 |
| 治疗用生物制品 | 23 |
| TCM | 16 |
| Biologic | 7 |
| 预防用生物制品 | 4 |
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
40 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 吸入用乙酰半胱氨酸溶液 | 2 | 2 | 4 |
| 2 | 重酒石酸间羟胺注射液 | 2 | 2 | 2 |
| 3 | 奥拉帕利片 | 2 | 1 | 0 |
| 4 | 氟马西尼注射液 | 2 | 1 | 2 |
| 5 | 盐酸乌拉地尔注射液 | 2 | 1 | 5 |
| 6 | 盐酸氨溴索滴剂 | 2 | 1 | 8 |
| 7 | 硫酸镁注射液 | 2 | 1 | 7 |
| 8 | 重酒石酸去甲肾上腺素注射液 | 2 | 1 | 9 |
| 9 | 乙酰半胱氨酸注射液 | 1 | 1 | 53 |
| 10 | 二羟丙茶碱注射液 | 1 | 1 | 7 |
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 | 福州基石医药科技有限公司 | 12 | 11 | 0 |
| 2 | 湖北美林药业有限公司 | 9 | 6 | 0 |
| 3 | Novo Nordisk A/S | 9 | 1 | 0 |
| 4 | 江右制药（常德）有限公司 | 6 | 6 | 0 |
| 5 | 安徽美誉制药有限公司 | 5 | 3 | 0 |
| 6 | 成都市海通药业有限公司 | 5 | 2 | 0 |
| 7 | 弘健制药（上海）有限公司 | 4 | 2 | 0 |
| 8 | AstraZeneca UK Limited | 4 | 1 | 0 |
| 9 | 艾缇亚（上海）制药有限公司 | 4 | 1 | 0 |
| 10 | 山西铭羽生物科技有限公司 | 3 | 3 | 1 |
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
65 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/10/29Import · Class 1 | VAY736注射液JXSL2200189 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/10/29Import · Class 1 | Imlunestrant 片JXHL2200318 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/10/29Generic · Class 3 | 硫酸镁注射液CYHS2201858 | 海南天盛保和生物科技有限公司; 河北天成药业股份有限公司 |
| 2022/10/29Generic · Class 3 | 硫酸镁注射液CYHS2201857 | 海南天盛保和生物科技有限公司; 河北天成药业股份有限公司 |
| 2022/10/29Generic · Class 3 | 盐酸丙卡特罗口服溶液CYHS2201853 | 浙江恒研医药科技有限公司; 浙江赛默制药有限公司 |
| 2022/10/29Generic · Class 3 | 注射用哌拉西林钠CYHS2201852 | 山西铭羽生物科技有限公司; 悦康药业集团股份有限公司 |
| 2022/10/29Generic · Class 3 | 重酒石酸去甲肾上腺素注射液CYHS2201851 | 成都欣捷高新技术开发股份有限公司; 四川美大康佳乐药业有限公司 |
| 2022/10/29Generic · Class 3 | 重酒石酸去甲肾上腺素注射液CYHS2201850 | 成都欣捷高新技术开发股份有限公司; 四川美大康佳乐药业有限公司 |
| 2022/10/29New drug · Class 1 | 人iPSC来源心肌细胞注射液CXSL2200547 | 南京艾尔普再生医学科技有限公司 |
| 2022/10/29New drug · Class 2.4 | 硫酸阿托品滴眼液CXHL2200846 | 浙江瑞瞳生物科技有限公司 |
| 2022/10/29New drug · Class 1 | TUL12101滴眼液CXHL2200845 | 珠海联邦制药股份有限公司 |
| 2022/10/29New drug · Class 1 | TUL12101滴眼液CXHL2200844 | 珠海联邦制药股份有限公司 |
| 2022/10/29New drug · Class 1 | TUL12101滴眼液CXHL2200843 | 珠海联邦制药股份有限公司 |
| 2022/10/28Import · Class 1 | elranatamabJXSL2200188 | Pfizer Inc; Pfizer Investment CO. Ltd. |
| 2022/10/28Import · Class 1 | Aticaprant 薄膜包衣片JXHL2200317 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/10/28Import · Class 2.2;2.4 | Delgocitinib乳膏JXHL2200316 | LEO Pharma A/S; LEO Pharma Consultancy (Shanghai) Company Limited |
| 2022/10/28Import · Class 2.2 | 阿塞那平透皮贴剂JXHL2200315 | LIAN HONG KONG LIMITED; Livzon (Group) Pharmaceutical Research Institute |
| 2022/10/28Import · Class 2.2 | 阿塞那平透皮贴剂JXHL2200314 | LIAN HONG KONG LIMITED; Livzon (Group) Pharmaceutical Research Institute |
| 2022/10/28Import · Class 2.2 | 阿塞那平透皮贴剂JXHL2200313 | LIAN HONG KONG LIMITED; Livzon (Group) Pharmaceutical Research Institute |
| 2022/10/28Generic · Class 3 | 布洛芬注射液CYHS2201847 | 海南合瑞制药股份有限公司 |
| 2022/10/28Generic · Class 3 | 盐酸丙卡特罗颗粒CYHS2201846 | 安徽百奥药业有限公司; 北京百奥药业有限责任公司 |
| 2022/10/28Generic · Class 3 | 盐酸氨溴索滴剂CYHS2201844 | 丽彩甘肃西峰制药有限公司 |
| 2022/10/28Generic · Class 3 | 盐酸氨溴索滴剂CYHS2201843 | 丽彩甘肃西峰制药有限公司 |
| 2022/10/28Generic · Class 3 | 氟尿嘧啶注射液CYHS2201842 | 海南卓科制药有限公司; 海口市制药厂有限公司 |
| 2022/10/28New drug · Class 1 | 自体淋巴细胞注射液CXSL2200546 | 北京康爱瑞浩生物科技股份有限公司 |
| 2022/10/28New drug · Class 2.2 | 孟鲁司特钠凝胶CXHL2200842 | 艾缇亚（上海）制药有限公司 |
| 2022/10/28New drug · Class 2.2 | 孟鲁司特钠凝胶CXHL2200841 | 艾缇亚（上海）制药有限公司 |
| 2022/10/28New drug · Class 2.2;2.4 | 孟鲁司特钠凝胶CXHL2200840 | 艾缇亚（上海）制药有限公司 |
| 2022/10/28New drug · Class 2.2;2.4 | 孟鲁司特钠凝胶CXHL2200839 | 艾缇亚（上海）制药有限公司 |
| 2022/10/28New drug · Class 2.4 | 泽布替尼胶囊CXHL2200838 | 百济神州（苏州）生物科技有限公司 |
35 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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