药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/12/16 – 2025/12/22
- New acceptances this week
- 397
- Drugs with new generic filings (by drug name, de-duplicated)
- 43
- Accepted this week, now under review
- 93
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
397filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 221 |
| New drug | 81 |
| Generic | 70 |
| Import | 9 |
| Unspecified | 8 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 200 |
| TCM | 124 |
| 治疗用生物制品 | 67 |
| 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
43 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 苯磺酸美洛加巴林片 | 4 | 1 | 58 |
| 2 | 巴瑞替尼片 | 3 | 2 | 32 |
| 3 | 非奈利酮片 | 3 | 2 | 71 |
| 4 | 利丙双卡因乳膏 | 3 | 1 | 25 |
| 5 | 枸橼酸西地那非片 | 3 | 1 | 12 |
| 6 | 草酸艾司西酞普兰口服溶液 | 3 | 1 | 11 |
| 7 | 制霉菌素口服混悬液 | 2 | 2 | 3 |
| 8 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 50 |
| 9 | 利伐沙班口崩片 | 2 | 1 | 4 |
| 10 | 双丙戊酸钠缓释片 | 2 | 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
220 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 吉林省德商药业股份有限公司 | 38 | 32 | 0 |
| 2 | 哈药集团世一堂制药厂 | 12 | 12 | 0 |
| 3 | 成都地奥集团天府药业股份有限公司 | 8 | 3 | 0 |
| 4 | Novo Nordisk A/S | 8 | 2 | 0 |
| 5 | 哈药集团三精儿童大药厂(有限公司) | 6 | 4 | 0 |
| 6 | 百济神州（苏州）生物科技有限公司 | 6 | 2 | 0 |
| 7 | 北京同仁堂科技发展股份有限公司制药厂 | 5 | 5 | 0 |
| 8 | 湖南千金湘江药业股份有限公司 | 5 | 3 | 5 |
| 9 | 成都百利多特生物药业有限责任公司 | 5 | 2 | 0 |
| 10 | 北京莲耳堂药业有限公司 | 4 | 4 | 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
110 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/22Import · Class 2.2 | 注射用德达博妥单抗JXSS2500151 | Daiichi Sankyo Europe GmbH; Simtra Deutschland GmbH |
| 2025/12/22Import · Class 1 | 注射用MK-2400JXSL2500244 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2025/12/22Import · Class 2.2;2.1 | 泰它西普注射液JXSL2500243 | Vor Biopharma Inc.; RemeGen Co. Ltd. |
| 2025/12/22Import · Class 1 | AZD5305JXHL2500389 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/12/22Generic · Class 3 | 盐酸维拉帕米注射液CYHS2504349 | 江苏福邦药业有限公司 |
| 2025/12/22Generic · Class 3 | 利伐沙班口崩片CYHS2504348 | 江西施美药业股份有限公司 |
| 2025/12/22Generic · Class 3 | 利伐沙班口崩片CYHS2504347 | 江西施美药业股份有限公司 |
| 2025/12/22Generic · Class 3 | 酮咯酸氨丁三醇片CYHS2504346 | 华东医药（西安）博华制药有限公司 |
| 2025/12/22Generic · Class 3 | 中性腹膜透析液（碳酸氢盐-G1.5%）CYHS2504343 | 石家庄四药有限公司 |
| 2025/12/22Generic · Class 3 | 唑尼沙胺片CYHS2504341 | 湖南尚众合生物医药有限公司; 天地恒一制药股份有限公司 |
| 2025/12/22Generic · Class 3 | 草酸艾司西酞普兰口服溶液CYHS2504337 | 哈尔滨市康隆药业有限责任公司 |
| 2025/12/22Generic · Class 3 | 草酸艾司西酞普兰口服溶液CYHS2504336 | 哈尔滨市康隆药业有限责任公司 |
| 2025/12/22Generic · Class 3 | 草酸艾司西酞普兰口服溶液CYHS2504335 | 哈尔滨市康隆药业有限责任公司 |
| 2025/12/22New drug · Class 3.4 | 人凝血酶原复合物CXSS2500143 | 远大蜀阳生命科学（成都）有限公司 |
| 2025/12/22New drug · Class 1 | 注射用LNF2105CXSL2501107 | 山东新时代药业有限公司 |
| 2025/12/22New drug · Class 1 | NT-001注射液CXSL2501106 | 上海奈康生物科技有限公司 |
| 2025/12/22New drug · Class 1 | 注射用BL-B01D1CXSL2501105 | 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司 |
| 2025/12/22New drug · Class 1 | 注射用BL-B01D1CXSL2501104 | 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司 |
| 2025/12/22New drug · Class 1 | 610细胞注射液CXSL2501103 | 北京卡替医疗技术有限公司 |
| 2025/12/22New drug · Class 1 | 注射用BL-B01D1CXSL2501102 | 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司 |
| 2025/12/22New drug · Class 1 | 注射用BL-B01D1CXSL2501101 | 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司 |
| 2025/12/22New drug · Class 2.2 | 伊基奥仑赛注射液CXSL2501100 | 南京驯鹿生物医药有限公司 |
| 2025/12/22New drug · Class 1 | INT-210胶囊CXHL2501428 | 宜坤行健生物医药（上海）有限公司 |
| 2025/12/22New drug · Class 1 | INT-210胶囊CXHL2501427 | 宜坤行健生物医药（上海）有限公司 |
| 2025/12/22New drug · Class 1 | H021肠溶片CXHL2501426 | 江苏柯菲平医药股份有限公司 |
| 2025/12/22New drug · Class 2.3 | BTP4327CXHL2501425 | 江苏诺和必拓新药研发有限公司; 北京阳光诺和药物研究股份有限公司; 北京百奥药业有限责任公司 |
| 2025/12/22New drug · Class 1 | HSK46575片CXHL2501424 | 辽宁海思科制药有限公司 |
| 2025/12/22New drug · Class 1 | HSK46575片CXHL2501423 | 辽宁海思科制药有限公司 |
| 2025/12/22New drug · Class 1 | HSK46575片CXHL2501422 | 辽宁海思科制药有限公司 |
| 2025/12/22New drug · Class 1 | RGT-274-CR胶囊CXHL2501419 | 上海齐鲁锐格医药研发有限公司 |
80 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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