药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/09/10 – 2024/09/16
- New acceptances this week
- 515
- Drugs with new generic filings (by drug name, de-duplicated)
- 106
- Accepted this week, now under review
- 10
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
515filings, 150 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 250 |
| Generic | 150 |
| New drug | 91 |
| Import | 16 |
| Import re-registration | 5 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 374 |
| TCM | 71 |
| 治疗用生物制品 | 62 |
| 预防用生物制品 | 6 |
| 体外诊断试剂 | 1 |
| Biologic | 1 |
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
106 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 布瑞哌唑片 | 6 | 2 | 31 |
| 2 | 盐酸左西替利嗪口服溶液 | 5 | 2 | 3 |
| 3 | 吸入用异丙托溴铵溶液 | 4 | 2 | 2 |
| 4 | 米诺地尔搽剂 | 4 | 2 | 49 |
| 5 | 乳果糖口服溶液 | 3 | 2 | 40 |
| 6 | 盐酸曲唑酮片 | 3 | 2 | 5 |
| 7 | 碳酸氢钠注射液 | 3 | 2 | 11 |
| 8 | 注射用头孢唑肟钠 | 3 | 1 | 6 |
| 9 | 盐酸尼卡地平注射液 | 3 | 1 | 12 |
| 10 | 吸入用乙酰半胱氨酸溶液 | 2 | 2 | 4 |
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
282 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 吉林新万联医药有限公司 | 49 | 48 | 0 |
| 2 | 安徽安科生物工程(集团)股份有限公司 | 10 | 3 | 0 |
| 3 | 齐鲁制药有限公司 | 8 | 3 | 0 |
| 4 | 甘李药业山东有限公司 | 8 | 1 | 0 |
| 5 | 江苏修正制药有限公司 | 6 | 6 | 0 |
| 6 | 安徽泰恩康制药有限公司 | 6 | 3 | 6 |
| 7 | Celgene Corporation | 6 | 1 | 0 |
| 8 | 苏州湃芮生物科技有限公司 | 6 | 1 | 0 |
| 9 | AstraZeneca AB | 5 | 3 | 0 |
| 10 | Pfizer Europe MA EEIG | 5 | 3 | 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
165 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/15Import · Class 1 | DS-1062aJXSL2400171 | ASTRAZENECA AB; AstraZeneca Investment (China) Co. Limited |
| 2024/09/15Import · Class 2.4 | 替尔泊肽注射液JXHS2400068 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/09/15Import · Class 2.4 | 替尔泊肽注射液JXHS2400067 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/09/15Import · Class 2.4 | 替尔泊肽注射液JXHS2400066 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/09/15Import · Class 2.4 | 替尔泊肽注射液JXHS2400065 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/09/15Generic · Class 3 | 碳酸氢钠林格注射液(I)CYHS2403111 | 浙江康吉尔药业有限公司 |
| 2024/09/15Generic · Class 3 | 对乙酰氨基酚维生素C泡腾片CYHS2403104 | 郑州泰丰制药有限公司 |
| 2024/09/15New drug · Class 1.2 | 复制缺陷型猴痘疫苗CXSL2400627 | 北京生物制品研究所有限责任公司 |
| 2024/09/15New drug · Class 1 | 注射用BG-C477CXSL2400626 | 广州百济神州生物制药有限公司 |
| 2024/09/15New drug · Class 2.2 | 司美格鲁肽注射液CXHS2400095 | 齐鲁制药有限公司 |
| 2024/09/15New drug · Class 2.2 | 司美格鲁肽注射液CXHS2400094 | 齐鲁制药有限公司 |
| 2024/09/15New drug · Class 2.4 | 注射用苯磺酸瑞马唑仑CXHS2400093 | 宜昌人福药业有限责任公司 |
| 2024/09/15New drug · Class 2.4 | 注射用苯磺酸瑞马唑仑CXHS2400092 | 宜昌人福药业有限责任公司 |
| 2024/09/15New drug · Class 1 | CMS-D005注射液CXHL2400975 | 深圳市康哲生物科技有限公司 |
| 2024/09/15New drug · Class 1 | CMS-D005注射液CXHL2400974 | 深圳市康哲生物科技有限公司 |
| 2024/09/14Import · Class 1 | AZD2936JXSL2400170 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/14Import · Class 2.2 | 度普利尤单抗注射液JXSL2400169 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2024/09/14Import · Class 1 | AZD0486JXSL2400168 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/14Import · Class 1 | DS-6000aJXSL2400167 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2024/09/14Import · Class 1 | AZD5462片JXHL2400218 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/14Import · Class 1 | AZD5462片JXHL2400217 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/14Generic · Class 3 | 脂溶性维生素注射液(Ⅱ)CYHS2403099 | 沈阳海思科制药有限公司 |
| 2024/09/14Generic · Class 3 | 维生素B6注射液CYHS2403098 | 广州艾奇西新药研究有限公司; 津药和平(天津)制药有限公司 |
| 2024/09/14Generic · Class 3 | 氯化钙注射液CYHS2403094 | 海南倍特药业有限公司 |
| 2024/09/14Generic · Class 3 | 氯化钙注射液CYHS2403093 | 海南倍特药业有限公司 |
| 2024/09/14Generic · Class 3 | 注射用左亚叶酸钙CYHS2403091 | 安徽省先锋制药有限公司 |
| 2024/09/14Generic · Class 3 | 硫酸麻黄碱注射液CYHS2403085 | 浙江普洛康裕制药有限公司 |
| 2024/09/14Generic · Class 3 | 硫酸镁注射液CYHS2403083 | 国药集团国瑞药业有限公司 |
| 2024/09/14Generic · Class 3 | 阿仑膦酸钠口服溶液CYHS2403082 | 武汉华尔生物科技有限公司; 湖北多瑞药业有限公司 |
| 2024/09/14Generic · Class 3 | 米诺地尔搽剂CYHS2403080 | 曼秀雷敦(中国)药业有限公司; 中山万汉制药有限公司 |
135 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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