药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/12/12 – 2023/12/18
- New acceptances this week
- 368
- Drugs with new generic filings (by drug name, de-duplicated)
- 62
- 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
368filings, 79 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 190 |
| Generic | 79 |
| New drug | 62 |
| Import | 24 |
| Unspecified | 8 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 239 |
| TCM | 69 |
| 治疗用生物制品 | 58 |
| Biologic | 1 |
| 预防用生物制品 | 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
62 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸他喷他多片 | 3 | 1 | 0 |
| 2 | 二甲双胍恩格列净片（I） | 2 | 2 | 2 |
| 3 | 吗啉硝唑氯化钠注射液 | 2 | 2 | 10 |
| 4 | 噻托溴铵吸入粉雾剂 | 2 | 2 | 2 |
| 5 | 地夸磷索钠滴眼液 | 2 | 2 | 5 |
| 6 | 地氯雷他定口服溶液 | 2 | 2 | 26 |
| 7 | 氢溴酸伏硫西汀片 | 2 | 2 | 8 |
| 8 | 氯化钾颗粒 | 2 | 2 | 4 |
| 9 | 重酒石酸去甲肾上腺素注射液 | 2 | 2 | 9 |
| 10 | 乙酰半胱氨酸口服溶液 | 2 | 1 | 11 |
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
208 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 蓝耘智合生物科技有限责任公司 | 12 | 11 | 0 |
| 2 | 山西仁源堂药业有限公司 | 10 | 10 | 0 |
| 3 | Novo Nordisk A/S | 10 | 1 | 0 |
| 4 | 成都地奥制药集团有限公司 | 8 | 2 | 0 |
| 5 | 湘北威尔曼制药股份有限公司 | 7 | 2 | 0 |
| 6 | 齐鲁安替制药有限公司 | 6 | 6 | 0 |
| 7 | 正大天晴药业集团南京顺欣制药有限公司 | 6 | 5 | 2 |
| 8 | Novartis Pharma Schweiz AG | 6 | 3 | 0 |
| 9 | Fresenius Kabi Austria GmbH | 6 | 1 | 0 |
| 10 | AstraZeneca AB | 5 | 5 | 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
118 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/18Generic · Class 3 | 复方匹可硫酸钠颗粒CYHS2303497 | 北京民康百草医药科技有限公司; 北京海王中新药业股份有限公司 |
| 2023/12/16Import · Class 3.1 | 注射用Andexanet alfaJXSS2300093 | AstraZeneca AB; Baxter Pharmaceutical Solutions LLC; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/12/16Import · Class 2.4 | MRTX849片JXHL2300315 | Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2023/12/16Generic · Class 3 | 注射用赖氨匹林CYHS2303496 | 海南天盛保和生物科技有限公司; 海南皇隆制药股份有限公司 |
| 2023/12/16Generic · Class 3 | 二羟丙茶碱注射液CYHS2303495 | 成都苑东生物制药股份有限公司 |
| 2023/12/16Generic · Class 3 | 氯化钾颗粒CYHS2303494 | 南京海鲸药业股份有限公司 |
| 2023/12/16Generic · Class 3 | 盐酸氨酮戊酸颗粒剂CYHL2300154 | 上海复旦张江生物医药股份有限公司 |
| 2023/12/16New drug · Class 1 | 口服重组人糜蛋白酶冻干粉CXSL2300868 | 武汉禾元生物科技股份有限公司 |
| 2023/12/16New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液CXSL2300867 | 石药集团中奇制药技术（石家庄）有限公司 |
| 2023/12/16New drug · Class 1 | SYSA1801注射液CXSL2300866 | 石药集团巨石生物制药有限公司 |
| 2023/12/16New drug · Class 1 | LVGN6051单克隆抗体注射液CXSL2300865 | 礼进生物医药科技（上海）有限公司 |
| 2023/12/16New drug · Class 3.3 | KH917注射液CXSL2300864 | 北京康弘生物医药有限公司 |
| 2023/12/16New drug · Class 1 | 注射用TQB2930CXSL2300863 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2023/12/16New drug · Class 2.2 | HQ-0124片CXHS2300117 | 上海则正医药科技股份有限公司; 华益泰康药业股份有限公司 |
| 2023/12/16New drug · Class 2.2 | HQ-0124片CXHS2300116 | 上海则正医药科技股份有限公司; 华益泰康药业股份有限公司 |
| 2023/12/16New drug · Class 1 | CB06-036CXHL2301402 | 上海挚盟医药科技有限公司 |
| 2023/12/16New drug · Class 1 | CB06-036CXHL2301401 | 上海挚盟医药科技有限公司 |
| 2023/12/16New drug · Class 1 | IAMA-001鼻用喷雾剂CXHL2301400 | 南京吉盛澳玛生物医药有限公司 |
| 2023/12/16New drug · Class 1 | IAMA-001鼻用喷雾剂CXHL2301399 | 南京吉盛澳玛生物医药有限公司 |
| 2023/12/16New drug · Class 1 | IAMA-001鼻用喷雾剂CXHL2301398 | 南京吉盛澳玛生物医药有限公司 |
| 2023/12/15Import · Class 3.1 | 阿柏西普眼内注射溶液JXSS2300092 | Bayer AG; Vetter Pharma-Fertigung GmbH & Co. KG; Bayer Healthcare Company Ltd. |
| 2023/12/15Import · Class 1 | AZD0486JXSL2300229 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/12/15Generic · Class 3 | 乙酰半胱氨酸注射液CYHS2303489 | 山东如至生物医药科技有限公司; 成都市海通药业有限公司 |
| 2023/12/15Generic · Class 3 | 注射用盐酸兰地洛尔CYHS2303488 | 成都苑东生物制药股份有限公司 |
| 2023/12/15Generic · Class 3 | 复方醋酸钠林格注射液CYHS2303486 | 广东科泓药业有限公司 |
| 2023/12/15Generic · Class 3 | 复方醋酸钠林格注射液CYHS2303485 | 广东科泓药业有限公司 |
| 2023/12/15Generic · Class 3 | 地奈德乳膏CYHS2303480 | 河北新张药股份有限公司; 河北亚东制药有限公司 |
| 2023/12/15Generic · Class 3 | 氯化钾颗粒CYHS2303479 | 苏州朗科生物技术股份有限公司; 南京海纳制药有限公司 |
| 2023/12/15Generic · Class 3 | 熊去氧胆酸片CYHS2303478 | 中山丽高生物医药有限公司; 安士制药（中山）有限公司 |
| 2023/12/15New drug · Class 3.4 | 人凝血因子ⅧCXSL2300862 | 四川远大蜀阳药业有限责任公司 |
88 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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