药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/03/22 – 2022/03/28
- New acceptances this week
- 207
- Drugs with new generic filings (by drug name, de-duplicated)
- 20
- 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
207filings, 24 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 107 |
| New drug | 41 |
| Generic | 24 |
| Import | 22 |
| Import re-registration | 8 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 143 |
| 治疗用生物制品 | 38 |
| TCM | 22 |
| Biologic | 2 |
| 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
20 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 利奥西呱片 | 3 | 1 | 4 |
| 2 | 葡萄糖酸钙注射液 | 2 | 1 | 5 |
| 3 | 重酒石酸卡巴拉汀胶囊 | 2 | 1 | 4 |
| 4 | 利丙双卡因乳膏 | 1 | 1 | 25 |
| 5 | 地高辛注射液 | 1 | 1 | 3 |
| 6 | 多索茶碱注射液 | 1 | 1 | 5 |
| 7 | 左氧氟沙星片 | 1 | 1 | 8 |
| 8 | 帕拉米韦注射液 | 1 | 1 | 7 |
| 9 | 普瑞巴林胶囊 | 1 | 1 | 12 |
| 10 | 氧(液态) | 1 | 1 | 2 |
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
121 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 合肥市未来药物开发有限公司 | 9 | 8 | 0 |
| 2 | 齐鲁制药有限公司 | 9 | 5 | 3 |
| 3 | AstraZeneca AB | 6 | 3 | 0 |
| 4 | 宜昌人福药业有限责任公司 | 5 | 3 | 1 |
| 5 | Janssen Research & Development LLC | 4 | 4 | 0 |
| 6 | 好医生药业集团有限公司 | 4 | 4 | 0 |
| 7 | 宜昌东阳光长江药业股份有限公司 | 4 | 1 | 0 |
| 8 | 广州喜鹊医药有限公司 | 4 | 1 | 0 |
| 9 | 河南润弘制药股份有限公司 | 3 | 3 | 0 |
| 10 | 湖南方盛制药股份有限公司 | 3 | 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
64 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/03/28Import · Class 1 | Marstacimab注射液JXSL2200041 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2022/03/28Generic · Class 3 | 地高辛注射液CYHS2200483 | 成都慧德医药科技有限公司; 成都市海通药业有限公司 |
| 2022/03/28New drug · Class 1 | 注射用HBM7008CXSL2200148 | 和铂医药（上海）有限责任公司 |
| 2022/03/28New drug · Class 1 | 重组人血小板源生长因子凝胶CXSL2200147 | 北京华芢生物技术有限公司 |
| 2022/03/28New drug · Class 1 | EXG001-307注射液CXSL2200146 | 杭州嘉因生物科技有限公司 |
| 2022/03/28New drug · Class 3.2 | 注射用重组替度鲁肽CXSL2200130 | 重庆派金生物科技有限公司 |
| 2022/03/28New drug · Class 1 | JS116胶囊CXHL2200195 | 上海君实生物医药科技股份有限公司 |
| 2022/03/28New drug · Class 1 | JDB383片CXHL2200194 | 上海嘉葆药银医药科技有限公司 |
| 2022/03/28New drug · Class 1 | JDB383片CXHL2200193 | 上海嘉葆药银医药科技有限公司 |
| 2022/03/28New drug · Class 2.2 | MTS004 口崩片CXHL2200192 | 杭州剂泰医药科技有限责任公司 |
| 2022/03/25Import · Class 1 | AZD8205JXSL2200040 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/03/25Import · Class 1 | KBP-5074片JXHL2200071 | KBP BioSciences PTE. Ltd.; KBP Biosciences Co. Ltd. |
| 2022/03/25Import · Class 1 | KBP-5074片JXHL2200070 | KBP Biosciences PTE. Ltd.; KBP Biosciences Co. Ltd. |
| 2022/03/25Import · Class 2.4 | 阿贝西利片JXHL2200066 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/03/25Import · Class 1 | Imlunestrant 片JXHL2200065 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/03/25New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2200145 | 贵州中观生物技术有限公司 |
| 2022/03/25New drug · Class 1 | LD002注射液CXSL2200144 | 浙江蓝盾药业有限公司 |
| 2022/03/25New drug · Class 2.4 | 单唾液酸四己糖神经节苷脂钠注射液CXHL2200188 | 齐鲁制药有限公司 |
| 2022/03/25New drug · Class 2.4 | 单唾液酸四己糖神经节苷脂钠注射液CXHL2200187 | 齐鲁制药有限公司 |
| 2022/03/25New drug · Class 2.2 | 丁苯酞注射液CXHL2200186 | 河北赛谱睿思医药科技有限公司 |
| 2022/03/25New drug · Class 2.4 | 康替唑胺片CXHL2200185 | 上海盟科药业股份有限公司 |
| 2022/03/25New drug · Class 1 | 西奥罗尼胶囊CXHL2200169 | 深圳微芯生物科技股份有限公司 |
| 2022/03/25New drug · Class 1 | 西奥罗尼胶囊CXHL2200168 | 深圳微芯生物科技股份有限公司 |
| 2022/03/24Import · Class 1 | Olvi-Vec注射液JXSL2200039 | Genelux Corporation; Newsoara Biopharma Co. Ltd. |
| 2022/03/24Import · Class 2.2 | Faricimab注射液JXSL2200038 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2022/03/24Import · Class 1 | Linzagolix片JXHL2200069 | Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd. |
| 2022/03/24Import · Class 1 | Linzagolix片JXHL2200068 | Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd. |
| 2022/03/24Import · Class 1 | Linzagolix片JXHL2200067 | Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd. |
| 2022/03/24New drug · Class 3.4 | 马破伤风免疫球蛋白F(ab′)2CXSS2200031 | 玉溪九洲生物技术有限责任公司 |
| 2022/03/24New drug · Class 1 | 注射用LM-108CXSL2200143 | 上海礼新医药研发有限公司 |
34 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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