药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/12/21 – 2021/12/27
- New acceptances this week
- 292
- Drugs with new generic filings (by drug name, de-duplicated)
- 41
- 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
292filings, 62 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 133 |
| Generic | 62 |
| New drug | 58 |
| Import | 18 |
| Unspecified | 13 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 198 |
| 治疗用生物制品 | 62 |
| TCM | 22 |
| 体外诊断试剂 | 4 |
| Biologic | 4 |
| 预防用生物制品 | 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
41 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 非布司他片 | 5 | 3 | 15 |
| 2 | 磷酸西格列汀片 | 4 | 2 | 2 |
| 3 | 丙戊酸钠注射用浓溶液 | 2 | 1 | 0 |
| 4 | 噁拉戈利片 | 2 | 1 | 2 |
| 5 | 奥扎格雷钠注射液 | 2 | 1 | 3 |
| 6 | 托拉塞米注射液 | 2 | 1 | 1 |
| 7 | 替吉奥胶囊 | 2 | 1 | 0 |
| 8 | 注射用尼可地尔 | 2 | 1 | 1 |
| 9 | 注射用盐酸吉西他滨 | 2 | 1 | 1 |
| 10 | 盐酸乌拉地尔注射液 | 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
169 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 安徽双鹤药业有限责任公司 | 12 | 3 | 0 |
| 2 | Boehringer Ingelheim International GmbH | 7 | 2 | 0 |
| 3 | Novo Nordisk A/S | 6 | 2 | 0 |
| 4 | 上海璎黎药业有限公司 | 6 | 2 | 0 |
| 5 | 绿十字（中国）生物制品有限公司 | 6 | 2 | 0 |
| 6 | 苏州华益美生物科技有限公司 | 4 | 4 | 0 |
| 7 | Pfizer Europe MA EEIG | 4 | 3 | 0 |
| 8 | 哈尔滨田美药业股份有限公司 | 4 | 3 | 0 |
| 9 | 上海凯茂生物医药有限公司 | 4 | 1 | 0 |
| 10 | 成都第一制药有限公司 | 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
100 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/12/27Import · Class 1 | EnpatoranJXHL2101286 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2021/12/27Generic · Class 3 | 盐酸西替利嗪口服溶液CYHS2102285 | 成都倍特得诺药业有限公司 |
| 2021/12/27Generic · Class 3 | 盐酸西替利嗪口服溶液CYHS2102284 | 成都倍特得诺药业有限公司 |
| 2021/12/27Generic · Class 3 | 氨甲环酸注射液CYHS2102283 | 吉林四长制药有限公司 |
| 2021/12/27New drug · Class 3.4 | 聚乙二醇重组人粒细胞刺激因子注射液CXSS2101082 | 北京双鹭药业股份有限公司 |
| 2021/12/27New drug · Class 3.4 | 聚乙二醇重组人粒细胞刺激因子注射液CXSS2101081 | 北京双鹭药业股份有限公司 |
| 2021/12/27New drug · Class 3.4 | 变应原皮肤点刺试验对照液CXSS2101080 | 浙江我武生物科技股份有限公司 |
| 2021/12/27New drug · Class 1 | 黄花蒿花粉点刺液CXSS2101079 | 浙江我武生物科技股份有限公司 |
| 2021/12/27New drug · Class 1 | 白桦花粉点刺液CXSS2101078 | 浙江我武生物科技股份有限公司 |
| 2021/12/27New drug · Class 1 | SI-B001双特异性抗体注射液CXSL2101511 | 四川百利药业有限责任公司 |
| 2021/12/27New drug · Class 2.5 | 冻干人用狂犬病疫苗（Vero细胞）CXSL2101503 | 长春卓谊生物股份有限公司 |
| 2021/12/27New drug · Class 3.3 | 吸附无细胞百白破/b型流感嗜血杆菌联合疫苗CXSL2101502 | 玉溪沃森生物技术有限公司; 云南沃森生物技术股份有限公司 |
| 2021/12/27New drug · Class 2.4 | 镥[177Lu]氧奥曲肽注射液CXHL2101814 | 北京先通国际医药科技股份有限公司 |
| 2021/12/27New drug · Class 1 | MDI-1228_mesylate凝胶CXHL2101813 | 河南迈英诺医药科技有限公司 |
| 2021/12/27New drug · Class 1 | MDI-1228_mesylate凝胶CXHL2101812 | 河南迈英诺医药科技有限公司 |
| 2021/12/27New drug · Class 1 | CX510片CXHL2101807 | 杭州邦顺制药有限公司 |
| 2021/12/24Import · Class 2.2 | 帕博利珠单抗注射液JXSL2101151 | Merck Sharp & Dohme Corp.; MSD R&D（China）Co. Ltd. |
| 2021/12/24Import · Class 1 | EnpatoranJXHL2101287 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2021/12/24Import · Class 2.4 | Belzutifan片JXHL2101285 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D（China）Co. Ltd. |
| 2021/12/24Import · Class 1 | LOXO-305片JXHL2101284 | Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/12/24Import · Class 1 | LOXO-305片JXHL2101283 | Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/12/24Import · Class 1 | LOXO-305片JXHL2101282 | Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/12/24Generic · Class 3 | 盐酸多巴胺注射液CYHS2102278 | 湖北神州华瑞医药有限公司; 山西振东泰盛制药有限公司 |
| 2021/12/24Generic · Class 3 | 盐酸多巴胺注射液CYHS2102277 | 湖北神州华瑞医药有限公司; 山西振东泰盛制药有限公司 |
| 2021/12/24Generic · Class 3 | 氟尿嘧啶注射液CYHS2102276 | 健进制药有限公司 |
| 2021/12/24Generic · Class 3 | 注射用尼可地尔CYHS2102275 | 南京恒道医药科技股份有限公司; 江苏九旭药业有限公司 |
| 2021/12/24Generic · Class 3 | 注射用尼可地尔CYHS2102274 | 南京恒道医药科技股份有限公司; 江苏九旭药业有限公司 |
| 2021/12/24Generic · Class 3 | 托拉塞米注射液CYHS2102273 | 南京正科医药股份有限公司; 山西普德药业有限公司 |
| 2021/12/24Generic · Class 3 | 托拉塞米注射液CYHS2102272 | 南京正科医药股份有限公司; 山西普德药业有限公司 |
| 2021/12/24Generic · Class 3 | 盐酸替罗非班氯化钠注射液CYHS2102271 | 沈阳双鼎制药有限公司 |
70 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.