药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/03/01 – 2022/03/07
- New acceptances this week
- 268
- Drugs with new generic filings (by drug name, de-duplicated)
- 23
- 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
268filings, 33 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 157 |
| New drug | 38 |
| Generic | 33 |
| Import re-registration | 17 |
| Import | 12 |
| Unspecified | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 156 |
| TCM | 77 |
| 治疗用生物制品 | 30 |
| 预防用生物制品 | 4 |
| 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
23 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 玻璃酸钠滴眼液 | 4 | 3 | 29 |
| 2 | 他达拉非片 | 4 | 1 | 23 |
| 3 | 屈螺酮炔雌醇片 | 2 | 1 | 1 |
| 4 | 托伐普坦片 | 2 | 1 | 0 |
| 5 | 精氨酸布洛芬颗粒 | 2 | 1 | 11 |
| 6 | 舒更葡糖钠注射液 | 2 | 1 | 6 |
| 7 | ω-3鱼油脂肪乳注射液 | 1 | 1 | 6 |
| 8 | 伏格列波糖片 | 1 | 1 | 0 |
| 9 | 吸入用硫酸沙丁胺醇溶液 | 1 | 1 | 2 |
| 10 | 左乙拉西坦口服溶液 | 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
117 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 吉林意达药业有限公司 | 34 | 33 | 0 |
| 2 | 桂林原承制药有限责任公司 | 20 | 19 | 0 |
| 3 | 黑龙江珍宝岛药业股份有限公司 | 18 | 18 | 0 |
| 4 | SHIN POONG Pharmaceutical Co. Ltd. | 8 | 2 | 0 |
| 5 | N.V. Organon | 6 | 3 | 0 |
| 6 | Eli Lilly and Company | 6 | 1 | 0 |
| 7 | 山东新时代药业有限公司 | 5 | 2 | 4 |
| 8 | Novo Nordisk A/S | 4 | 2 | 0 |
| 9 | N.V.Organon | 4 | 1 | 0 |
| 10 | PFIZER EUROPE MA EEIG | 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
53 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/03/07Import · Class 2.2 | RO7198574JXSL2200024 | F.Hoffmann-La Roche Ltd; Roche（China）Holding Ltd. |
| 2022/03/07Import · Class 2.2 | RO7198574JXSL2200023 | F.Hoffmann-La Roche Ltd; Roche（China）Holding Ltd. |
| 2022/03/07Import · Class 1 | GDC-9545JXHL2200052 | F. Hoffmann-La Roche Ltd; Roche（China）Holding Ltd. |
| 2022/03/07New drug · Class 1 | ASKG712注射液CXSL2200121 | 苏州奥赛康生物医药有限公司 |
| 2022/03/07New drug · Class 1 | MNC-168肠溶胶囊CXSL2200119 | 慕恩（广州）生物科技有限公司 |
| 2022/03/07New drug · Class 1 | MNC-168肠溶胶囊CXSL2200118 | 慕恩（广州）生物科技有限公司 |
| 2022/03/07New drug · Class 1 | MNC-168肠溶胶囊CXSL2200117 | 慕恩（广州）生物科技有限公司 |
| 2022/03/07New drug · Class 1 | MNC-168肠溶胶囊CXSL2200116 | 慕恩（广州）生物科技有限公司 |
| 2022/03/07New drug · Class 1 | 治疗用艾滋病核酸注射液CXSL2200115 | 深圳医克生物医药有限公司 |
| 2022/03/07New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2200114 | 上海泉生生物科技有限公司 |
| 2022/03/07New drug · Class 2.2 | 普拉克索透皮贴剂CXHL2200146 | 广东红珊瑚药业有限公司 |
| 2022/03/07New drug · Class 2.1;2.2 | 注射用HR18034CXHL2200145 | 上海恒瑞医药有限公司 |
| 2022/03/07New drug · Class 2.2 | 枸橼酸莫沙必利注射液CXHL2200140 | 山东新时代药业有限公司 |
| 2022/03/07New drug · Class 2.2 | OT-601-CCXHL2200135 | 苏州欧康维视生物科技有限公司 |
| 2022/03/04Import · Class 1 | TremelimumabJXSL2200021 | MedImmune LLC; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/03/04Generic · Class 3 | 异硫蓝注射液CYHS2200409 | 广东和博制药有限公司; 广东星昊药业有限公司 |
| 2022/03/04Generic · Class 3 | 胞磷胆碱钠注射液CYHS2200408 | 广州绿十字制药股份有限公司; 成都市海通药业有限公司 |
| 2022/03/04New drug · Class 1 | 注射用QLS31904CXSL2200113 | 齐鲁制药有限公司 |
| 2022/03/04New drug · Class 1 | TG103注射液CXSL2200109 | 石药集团百克（山东）生物制药股份有限公司 |
| 2022/03/04New drug · Class 1 | HEC137076MsOH片CXHL2200139 | 广东东阳光药业有限公司 |
| 2022/03/04New drug · Class 1 | HEC137076MsOH片CXHL2200138 | 广东东阳光药业有限公司 |
| 2022/03/04New drug · Class 1 | HEC137076MsOH片CXHL2200137 | 广东东阳光药业有限公司 |
| 2022/03/04New drug · Class 2.2 | HR19042胶囊CXHL2200136 | 江苏恒瑞医药股份有限公司 |
| 2022/03/04New drug · Class 1 | FCN-159片CXHL2200134 | 上海复星医药产业发展有限公司 |
| 2022/03/04New drug · Class 1 | FCN-159片CXHL2200133 | 上海复星医药产业发展有限公司 |
| 2022/03/04New drug · Class 1 | FCN-159片CXHL2200132 | 上海复星医药产业发展有限公司 |
| 2022/03/03Generic · Class 3 | 聚卡波非钙片CYHL2200022 | 浙江佐力药业股份有限公司 |
| 2022/03/03New drug · Class 1 | 注射用CS5001CXSL2200112 | 基石药业（苏州）有限公司 |
| 2022/03/03New drug · Class 1 | DXC004ACXSL2200111 | 杭州多禧生物科技有限公司 |
| 2022/03/03New drug · Class 1 | GZR101CXSL2200110 | 甘李药业股份有限公司 |
23 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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