药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/08/16 – 2022/08/22
- New acceptances this week
- 270
- Drugs with new generic filings (by drug name, de-duplicated)
- 41
- 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
270filings, 61 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 128 |
| Generic | 61 |
| New drug | 34 |
| Import | 21 |
| Import re-registration | 17 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 211 |
| 治疗用生物制品 | 36 |
| TCM | 20 |
| Biologic | 2 |
| 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
41 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 泊马度胺胶囊 | 4 | 1 | 4 |
| 2 | 孟鲁司特钠咀嚼片 | 3 | 2 | 4 |
| 3 | 碳酸氢钠林格注射液 | 3 | 2 | 1 |
| 4 | 磷酸奥司他韦胶囊 | 3 | 1 | 42 |
| 5 | 磷酸西格列汀片 | 3 | 1 | 2 |
| 6 | 钆喷酸葡胺注射液 | 3 | 1 | 9 |
| 7 | 吸入用乙酰半胱氨酸溶液 | 2 | 2 | 4 |
| 8 | 他达拉非片 | 2 | 1 | 23 |
| 9 | 恩替卡韦片 | 2 | 1 | 0 |
| 10 | 碳酸司维拉姆干混悬剂 | 2 | 1 | 3 |
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
167 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖北荟海医药技术研究院有限公司 | 15 | 15 | 0 |
| 2 | 陕西年青保制药有限公司 | 10 | 10 | 0 |
| 3 | 齐鲁制药有限公司 | 6 | 2 | 4 |
| 4 | 国药集团工业有限公司 | 5 | 5 | 0 |
| 5 | Bristol-Myers Squibb Pharma EEIG | 5 | 1 | 0 |
| 6 | 丽珠集团丽珠制药厂 | 5 | 1 | 0 |
| 7 | 山东齐都药业有限公司 | 4 | 2 | 4 |
| 8 | Sanofi-aventis groupe | 4 | 1 | 0 |
| 9 | Atlantic Laboratories Corporation Ltd. | 3 | 1 | 0 |
| 10 | Santen Pharmaceutical Co. Ltd. | 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
72 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/08/22Import · Class 1 | RO7247669注射液JXSL2200139 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd |
| 2022/08/22Import · Class 1 | LOU064片JXHL2200248 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/08/22Generic · Class 3 | 阿立哌唑口服溶液CYHS2201311 | 沈阳天邦药业有限公司 |
| 2022/08/22Generic · Class 3 | 酒石酸匹莫范色林胶囊CYHL2200072 | 成都康弘药业集团股份有限公司 |
| 2022/08/22Generic · Class 3 | 吸入用盐酸溴己新溶液CYHL2200070 | 合肥国药诺和药业有限公司 |
| 2022/08/22New drug · Class 1 | AK129注射液CXSL2200395 | 中山康方生物医药有限公司 |
| 2022/08/22New drug · Class 1 | 重组人源化抗HER2双特异性抗体注射液CXSL2200390 | 上海津曼特生物科技有限公司 |
| 2022/08/22New drug · Class 1 | PM8002注射液CXSL2200389 | 普米斯生物技术（珠海）有限公司 |
| 2022/08/22New drug · Class 1 | GC101CXSL2200388 | 上海精缮生物科技有限责任公司 |
| 2022/08/22New drug · Class 1 | HLX22单抗注射液CXSL2200386 | 上海复宏汉霖生物技术股份有限公司 |
| 2022/08/22New drug · Class 1 | 斯鲁利单抗注射液CXSL2200385 | 上海复宏汉霖生物技术股份有限公司 |
| 2022/08/22New drug · Class 1 | JS015注射液CXSL2200380 | 上海君实生物医药科技股份有限公司 |
| 2022/08/22New drug · Class 1 | TR64片CXHL2200606 | 安徽中科拓苒药物科学研究有限公司 |
| 2022/08/22New drug · Class 2.2;2.4 | 艾普拉唑微丸肠溶片CXHL2200605 | 丽珠集团丽珠制药厂 |
| 2022/08/22New drug · Class 2.2;2.4 | 艾普拉唑微丸肠溶片CXHL2200604 | 丽珠集团丽珠制药厂 |
| 2022/08/22New drug · Class 2.2;2.4 | 艾普拉唑微丸肠溶片CXHL2200602 | 丽珠集团丽珠制药厂 |
| 2022/08/22New drug · Class 2.2;2.4 | 艾普拉唑微丸肠溶片CXHL2200601 | 丽珠集团丽珠制药厂 |
| 2022/08/22New drug · Class 2.2 | 艾普拉唑微丸肠溶片CXHL2200600 | 丽珠集团丽珠制药厂 |
| 2022/08/19Generic · Class 3 | 碳酸氢钠林格注射液CYHS2201348 | 山东齐都药业有限公司 |
| 2022/08/19Generic · Class 3 | 碳酸氢钠林格注射液CYHS2201347 | 山东齐都药业有限公司 |
| 2022/08/19Generic · Class 3 | 帕拉米韦注射液CYHS2201341 | 海南葫芦娃药业集团股份有限公司 |
| 2022/08/19Generic · Class 3 | 镓[68Ga]多特安肽注射液CYHL2200068 | 原子高科股份有限公司 |
| 2022/08/19Generic · Class 3 | 注射用多特安肽药盒CYHL2200067 | 原子高科股份有限公司 |
| 2022/08/19New drug · Class 3.3 | 注射用重组人促卵泡激素CXSL2200384 | 成都景泽生物制药有限公司 |
| 2022/08/19New drug · Class 2.1 | 人干扰素α1b吸入溶液CXSL2200383 | 深圳科兴药业有限公司 |
| 2022/08/19New drug · Class 2.1 | 人干扰素α1b吸入溶液CXSL2200382 | 深圳科兴药业有限公司 |
| 2022/08/19New drug · Class 1 | 注射用重组人源化抗HER2单抗-AS269偶联物（ARX788）CXSL2200381 | 浙江新码生物医药有限公司 |
| 2022/08/19New drug · Class 1 | STC007注射液CXHL2200599 | 成都诺和晟泰生物科技有限公司 |
| 2022/08/19New drug · Class 1 | JAB-2485片CXHL2200598 | 北京加科思新药研发有限公司 |
| 2022/08/19New drug · Class 1 | JAB-2485片CXHL2200597 | 北京加科思新药研发有限公司 |
42 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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