药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/03/03 – 2026/03/09
- New acceptances this week
- 337
- Drugs with new generic filings (by drug name, de-duplicated)
- 17
- Accepted this week, now under review
- 75
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
337filings, 23 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 224 |
| New drug | 56 |
| Generic | 23 |
| Import | 23 |
| Import re-registration | 7 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 152 |
| TCM | 110 |
| 治疗用生物制品 | 68 |
| 预防用生物制品 | 6 |
| 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
17 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸西替利嗪口服溶液 | 3 | 1 | 6 |
| 2 | 磷苯妥英钠注射用浓溶液 | 2 | 1 | 6 |
| 3 | 醋酸葡萄糖维持液 | 2 | 1 | 4 |
| 4 | 钆特醇注射液 | 2 | 1 | 3 |
| 5 | 非奈利酮片 | 2 | 1 | 71 |
| 6 | 乙酰半胱氨酸注射液 | 1 | 1 | 53 |
| 7 | 乙酰半胱氨酸片 | 1 | 1 | 8 |
| 8 | 二甲双胍恩格列净片（I） | 1 | 1 | 2 |
| 9 | 二甲双胍恩格列净片（VI） | 1 | 1 | 2 |
| 10 | 二甲双胍恩格列净片（V） | 1 | 1 | 1 |
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
178 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 宏济堂制药（莱芜区）有限公司 | 17 | 14 | 0 |
| 2 | Bayer Vital GmbH | 16 | 1 | 0 |
| 3 | 湖北一半天制药有限公司 | 9 | 2 | 0 |
| 4 | Eli Lilly and Company | 8 | 4 | 0 |
| 5 | 内蒙古库伦蒙药有限公司 | 6 | 6 | 0 |
| 6 | 天津宏仁堂药业有限公司 | 6 | 6 | 0 |
| 7 | Amgen Inc. | 6 | 1 | 0 |
| 8 | 山西黄河中药有限公司 | 5 | 5 | 0 |
| 9 | 陕西盘龙药业集团股份有限公司 | 5 | 5 | 0 |
| 10 | Novo Nordisk A/S | 5 | 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
90 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/03/09Generic · Class 3 | 盐酸吉西他滨注射液CYHS2600632 | 合肥力成药业有限公司 |
| 2026/03/09New drug · Class 2.1 | 特瑞普利单抗注射液（皮下注射）CXSS2600038 | 上海君实生物医药科技股份有限公司; 上海君实生物工程有限公司 |
| 2026/03/09New drug · Class 2.1 | 特瑞普利单抗注射液（皮下注射）CXSS2600037 | 上海君实生物医药科技股份有限公司; 上海君实生物工程有限公司 |
| 2026/03/09New drug · Class 2.1 | 特瑞普利单抗注射液（皮下注射）CXSS2600036 | 上海君实生物医药科技股份有限公司; 上海君实生物工程有限公司 |
| 2026/03/09New drug · Class 2.1 | 特瑞普利单抗注射液（皮下注射）CXSS2600035 | 上海君实生物医药科技股份有限公司; 上海君实生物工程有限公司 |
| 2026/03/09New drug · Class 1 | 熊去氧胆小檗碱胶囊CXHS2600040 | 深圳君圣泰生物技术有限公司; 无锡合全药业有限公司 |
| 2026/03/07Generic · Class 3 | 磷苯妥英钠注射用浓溶液CYHS2600629 | 福安药业集团烟台只楚药业有限公司 |
| 2026/03/07Generic · Class 3 | 磷苯妥英钠注射用浓溶液CYHS2600628 | 福安药业集团烟台只楚药业有限公司 |
| 2026/03/07New drug · Class 2.2 | 冻干口服轮状减毒活疫苗（Vero细胞）CXSL2600315 | 成都迈科康生物科技股份有限公司; 成都华任康生物科技有限公司; 上海迈科康生物科技有限公司 |
| 2026/03/07New drug · Class 1 | 注射用MK-1045CXSL2600314 | 默沙东研发（中国）有限公司 |
| 2026/03/07New drug · Class 1 | GR1803注射液（皮下注射）CXSL2600313 | 重庆智翔金泰生物制药股份有限公司 |
| 2026/03/07New drug · Class 1 | 注射用MK-1045CXSL2600312 | 默沙东研发（中国）有限公司 |
| 2026/03/07New drug · Class 1.2 | 重组呼吸道合胞病毒疫苗（CHO细胞）CXSL2600311 | 易康生物（苏州）有限公司 |
| 2026/03/07New drug · Class 1 | RLX-2505注射液CXSL2600310 | 苏州拓界医药有限公司 |
| 2026/03/07New drug · Class 1.2 | 重组呼吸道合胞病毒疫苗（CHO细胞）（佐剂）CXSL2600309 | 易康生物（苏州）有限公司 |
| 2026/03/07New drug · Class 1 | SYH2095片CXHL2600281 | 杭州英创医药科技有限公司; 石药集团中奇制药技术（石家庄）有限公司 |
| 2026/03/07New drug · Class 1 | SYH2095片CXHL2600280 | 杭州英创医药科技有限公司; 石药集团中奇制药技术（石家庄）有限公司 |
| 2026/03/07New drug · Class 1 | HS-10541片CXHL2600279 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2026/03/07New drug · Class 1 | HS-10541片CXHL2600278 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2026/03/07New drug · Class 2.2 | BCM993CXHL2600277 | 上海云晟研新生物科技股份有限公司 |
| 2026/03/07New drug · Class 1 | D3S-003片CXHL2600276 | 德昇济医药（无锡）有限公司 |
| 2026/03/06Import · Class 2.2 | 帕博利珠单抗注射液JXSS2600020 | MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2026/03/06Import · Class 2.4 | 贝组替凡片JXHS2600030 | MERCK SHARP & DOHME (UK) LIMITED; MSD INTERNATIONAL GMBH; MSD R&D (China) Co. Ltd |
| 2026/03/06Generic · Class 3 | 乙酰半胱氨酸片CYHS2600621 | 河北瑞森药业有限公司 |
| 2026/03/06Generic · Class 3 | 盐酸西替利嗪口服溶液CYHS2600618 | 北京韩美生物科技有限公司; 北京韩美药品有限公司 |
| 2026/03/06Generic · Class 3 | 盐酸西替利嗪口服溶液CYHS2600617 | 北京韩美生物科技有限公司; 北京韩美药品有限公司 |
| 2026/03/06Generic · Class 3 | 盐酸西替利嗪口服溶液CYHS2600616 | 北京韩美生物科技有限公司; 北京韩美药品有限公司 |
| 2026/03/06Generic · Class 3 | 醋酸葡萄糖维持液CYHS2600615 | 成都赛诺联创生物科技有限公司; 四川太平洋药业有限责任公司 |
| 2026/03/06Generic · Class 3 | 醋酸葡萄糖维持液CYHS2600614 | 成都赛诺联创生物科技有限公司; 四川太平洋药业有限责任公司 |
| 2026/03/06New drug · Class 1.1 | 小儿健脾消食颗粒CXZL2600026 | 山东汉方制药股份有限公司 |
60 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.