药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/03/09 – 2021/03/15
- New acceptances this week
- 194
- Drugs with new generic filings (by drug name, de-duplicated)
- 17
- 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
194filings, 27 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 95 |
| New drug | 29 |
| Generic | 27 |
| Import re-registration | 18 |
| Import | 16 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 138 |
| 治疗用生物制品 | 32 |
| TCM | 17 |
| 预防用生物制品 | 7 |
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
17 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 恩扎卢胺软胶囊 | 3 | 3 | 2 |
| 2 | 二甲磺酸赖右苯丙胺胶囊 | 3 | 1 | 0 |
| 3 | 左乙拉西坦氯化钠注射液 | 3 | 1 | 2 |
| 4 | 左氧氟沙星片 | 2 | 1 | 8 |
| 5 | 盐酸溴己新颗粒 | 2 | 1 | 0 |
| 6 | 盐酸西那卡塞片 | 2 | 1 | 2 |
| 7 | 艾司奥美拉唑镁肠溶胶囊 | 2 | 1 | 4 |
| 8 | 他达拉非片 | 1 | 1 | 23 |
| 9 | 吸入用盐酸氨溴索溶液 | 1 | 1 | 10 |
| 10 | 拉考沙胺口服溶液 | 1 | 1 | 0 |
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
124 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 南京药捷安康生物科技有限公司 | 7 | 3 | 0 |
| 2 | Astrazeneca UK Limited | 6 | 1 | 0 |
| 3 | Boehringer Ingelheim International GmbH | 6 | 1 | 0 |
| 4 | Fresenius Kabi Austria GmbH | 6 | 1 | 0 |
| 5 | Santen Pharmaceutical Co. Ltd. | 4 | 1 | 0 |
| 6 | 悦康药业集团股份有限公司 | 3 | 3 | 0 |
| 7 | SANOFI PASTEUR | 3 | 2 | 0 |
| 8 | 辰欣药业股份有限公司 | 3 | 2 | 1 |
| 9 | Daiichi Sankyo Europe GmbH | 3 | 1 | 0 |
| 10 | Sanofi-Aventis Deutschland GmbH | 3 | 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
50 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/03/12Import · Class 1 | Berzosertib注射液JXHL2100087 | Merck Healthcare KGaA |
| 2021/03/12Generic · Class 3 | 注射用两性霉素B脂质体CYHS2101018 | 石药集团中诺药业（石家庄）有限公司 |
| 2021/03/12Generic · Class 3 | 吸入用盐酸氨溴索溶液CYHS2100278 | 华润双鹤利民药业（济南）有限公司 |
| 2021/03/12Generic · Class 3 | 盐酸溴己新颗粒CYHS2100274 | 江西亿友药业有限公司 |
| 2021/03/12Generic · Class 3 | 盐酸溴己新颗粒CYHS2100273 | 江西亿友药业有限公司 |
| 2021/03/12New drug · Class 1 | AK104注射液CXSL2100095 | 康方药业有限公司 |
| 2021/03/12New drug · Class 1 | AK109注射液CXSL2100094 | 康融东方（广东）医药有限公司 |
| 2021/03/12New drug · Class 1 | AK112注射液CXSL2100093 | 中山康方生物医药有限公司 |
| 2021/03/12New drug · Class 2.2 | 康柏西普眼用注射液CXSL2100092 | 成都康弘生物科技有限公司 |
| 2021/03/12New drug · Class 1 | REGEND001细胞自体回输制剂CXSL2100091 | 江西省仙荷医学科技有限公司 |
| 2021/03/12New drug · Class 3.4 | 人凝血因子ⅧCXSL2100090 | 河北大安制药有限公司 |
| 2021/03/12New drug · Class 1 | TNM002注射液CXSL2100089 | 珠海泰诺麦博生物技术有限公司 |
| 2021/03/12New drug · Class 1 | SHR3680片CXHL2100183 | 江苏恒瑞医药股份有限公司 |
| 2021/03/12New drug · Class 1 | TT-00434片CXHL2100182 | 南京药捷安康生物科技有限公司 |
| 2021/03/12New drug · Class 1 | TT-00434片CXHL2100181 | 南京药捷安康生物科技有限公司 |
| 2021/03/12New drug · Class 1 | 注射用MT1002CXHL2100180 | 陕西麦科奥特科技有限公司 |
| 2021/03/11Import · Class 2.2 | 帕博利珠单抗注射液JXSL2100041 | Merck Sharp & Dohme Corp. |
| 2021/03/11Import · Class 1 | KSI-301注射液JXSL2100040 | Kodiak Sciences China Inc. |
| 2021/03/11Import · Class 1 | KSI-301注射液JXSL2100039 | Kodiak Sciences China Inc. |
| 2021/03/11Import · Class 1 | IMSA101注射液JXHL2100084 | ImmuneSensor Therapeutics Inc. |
| 2021/03/11New drug · Class 1 | TT-01025-CL片CXHL2100176 | 南京药捷安康生物科技有限公司 |
| 2021/03/11New drug · Class 1 | TT-01025-CL片CXHL2100175 | 南京药捷安康生物科技有限公司 |
| 2021/03/11New drug · Class 1 | ASC40片CXHL2100174 | 甘莱制药有限公司 |
| 2021/03/11New drug · Class 1 | ASC40片CXHL2100173 | 甘莱制药有限公司 |
| 2021/03/11New drug · Class 1 | ASC40片CXHL2100172 | 甘莱制药有限公司 |
| 2021/03/10Import · Class 1 | MK-7684A注射液JXSL2101001 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/03/10Import · Class 1 | MK-7684A注射液JXSL2101000 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/03/10Import · Class 1 | PF-07256472JXSL2100038 | Pfizer Inc. |
| 2021/03/10Import · Class 1 | Xevinapant口服溶液JXHL2100083 | Debiopharm International SA |
| 2021/03/10Generic · Class 3 | 左乙拉西坦氯化钠注射液CYHS2100271 | 河北仁合益康药业有限公司 |
20 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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