药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/10/11 – 2022/10/17
- New acceptances this week
- 310
- Drugs with new generic filings (by drug name, de-duplicated)
- 51
- 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
310filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 172 |
| Generic | 70 |
| New drug | 36 |
| Import | 15 |
| Import re-registration | 15 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 241 |
| 治疗用生物制品 | 30 |
| TCM | 29 |
| 预防用生物制品 | 8 |
| 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
51 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 氯化钾颗粒 | 3 | 2 | 4 |
| 2 | 复方α-酮酸片 | 2 | 2 | 0 |
| 3 | 格隆溴铵新斯的明注射液 | 2 | 2 | 3 |
| 4 | 甲泼尼龙片 | 2 | 2 | 3 |
| 5 | 丁酸氯维地平注射用乳剂 | 2 | 1 | 0 |
| 6 | 复方醋酸钠林格注射液 | 2 | 1 | 2 |
| 7 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 8 | 帕利哌酮缓释片 | 2 | 1 | 4 |
| 9 | 替米沙坦片 | 2 | 1 | 4 |
| 10 | 注射用哌拉西林钠他唑巴坦钠 | 2 | 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
189 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 广西迪泰制药股份有限公司 | 12 | 10 | 0 |
| 2 | 海南制药厂有限公司武汉分公司 | 10 | 10 | 0 |
| 3 | 广西圣民制药有限公司 | 9 | 9 | 0 |
| 4 | AstraZeneca UK Limited | 7 | 1 | 0 |
| 5 | AbbVie Inc. | 4 | 2 | 0 |
| 6 | Bayer AG | 4 | 2 | 0 |
| 7 | 江苏恩华药业股份有限公司 | 4 | 2 | 0 |
| 8 | 江苏睿实生物科技有限公司 | 4 | 2 | 4 |
| 9 | 海南美兰史克制药有限公司 | 4 | 2 | 0 |
| 10 | Albireo AB | 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
80 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/10/17New drug · Class 1 | 盐酸杰克替尼片CXHS2200054 | 苏州泽璟生物制药股份有限公司 |
| 2022/10/17New drug · Class 1 | MB-102注射液CXHL2200798 | 杭州中美华东制药有限公司 |
| 2022/10/15Import · Class 1 | BMS-986278-01片JXHL2200305 | Bristol-Myers Squibb Company; Bristol-Myers Squibb（China）Investment Co. Ltd |
| 2022/10/15Import · Class 1 | BMS-986278-01片JXHL2200304 | Bristol-Myers Squibb Company; Bristol-Myers Squibb（China）Investment Co. Ltd |
| 2022/10/15Import · Class 2.4 | Odevixibat 胶囊JXHL2200303 | Albireo AB; Syneos Health (Beijing) Inc.Ltd |
| 2022/10/15Import · Class 2.4 | Odevixibat 胶囊JXHL2200302 | Albireo AB; Syneos Health (Beijing) Inc.Ltd |
| 2022/10/15Import · Class 2.4 | Odevixibat 胶囊JXHL2200301 | Albireo AB; Syneos Health (Beijing) Inc.Ltd |
| 2022/10/15Import · Class 2.4 | Odevixibat 胶囊JXHL2200300 | Albireo AB; Syneos Health (Beijing) Inc.Ltd |
| 2022/10/15Generic · Class 3 | 氯化钾颗粒CYHS2201746 | 东阳祥昇医药科技有限公司; 浙江北生药业汉生制药有限公司 |
| 2022/10/15Generic · Class 3 | 氯化钾颗粒CYHS2201744 | 东阳祥昇医药科技有限公司; 浙江北生药业汉生制药有限公司 |
| 2022/10/15Generic · Class 3 | 美洛昔康纳晶注射液CYHL2200092 | 石药集团中奇制药技术（石家庄）有限公司 |
| 2022/10/14Import · Class 1 | ChAdOx1-HBVJXSL2200183 | Vaccitech (UK) Ltd; Novotech Clinical Services (Shanghai) Co. Ltd. |
| 2022/10/14Import · Class 1 | MVA-HBVJXSL2200182 | Vaccitech (UK) Ltd; Novotech Clinical Services (Shanghai) Co. Ltd. |
| 2022/10/14Generic · Class 3 | 富马酸福莫特罗吸入溶液CYHS2201741 | 南京海纳医药科技股份有限公司; 江苏大红鹰恒顺药业有限公司 |
| 2022/10/14Generic · Class 3 | 复方醋酸钠林格注射液CYHS2201740 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2022/10/14Generic · Class 3 | 复方醋酸钠林格注射液CYHS2201739 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2022/10/14Generic · Class 3 | 帕拉米韦注射液CYHS2201738 | 福安药业集团烟台只楚药业有限公司 |
| 2022/10/14Generic · Class 3 | 克拉屈滨注射液CYHS2201733 | 四川汇宇制药股份有限公司 |
| 2022/10/14Generic · Class 3 | 环孢素滴眼液CYHL2200091 | 艾尔健康眼药（辽宁）有限公司 |
| 2022/10/14Generic · Class 3 | 格隆溴铵新斯的明注射液CYHL2200090 | 江苏华泰晨光药业有限公司 |
| 2022/10/14Generic · Class 3 | 格隆溴铵新斯的明注射液CYHL2200089 | 上药东英（江苏）药业有限公司 |
| 2022/10/14New drug · Class 3.3 | 四价流感病毒裂解疫苗CXSS2200083 | 复星雅立峰（大连）生物制药有限公司 |
| 2022/10/14New drug · Class 1 | PM8002注射液CXSL2200516 | 普米斯生物技术（珠海）有限公司 |
| 2022/10/14New drug · Class 1 | TB-B002D注射液CXHL2200797 | 深圳市图微安创科技开发有限公司 |
| 2022/10/14New drug · Class 1 | TB-B002D注射液CXHL2200796 | 深圳市图微安创科技开发有限公司 |
| 2022/10/14New drug · Class 2.2 | 注射用醋酸戈舍瑞林缓释微球CXHL2200795 | 山东绿叶制药有限公司 |
| 2022/10/14New drug · Class 1 | [177Lu]Lu-XT033注射液CXHL2200794 | 北京先通国际医药科技股份有限公司 |
| 2022/10/13Import · Class 2.2 | Teclistamab 注射液JXSL2200181 | Janssen Research & Development， LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/10/13Import · Class 2.2 | Teclistamab 注射液JXSL2200180 | Janssen Research & Development， LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/10/13Generic · Class 3 | 醋酸钠林格葡萄糖注射液CYHS2201730 | 扬子江药业集团上海海尼药业有限公司 |
50 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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