YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 354 drug applications between 22 July 2024 and 28 July 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 94, covering 64 drug names.
2024/07/22 – 2024/07/28
- New acceptances this week
- 354
- Drugs with new generic filings (by drug name, de-duplicated)
- 64
- Accepted this week, now under review
- 4
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.
Names with a public page are linked.
New acceptances this week
By application type and drug type
354filings, 94 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 165 |
| Generic | 94 |
| New drug | 57 |
| Unspecified | 22 |
| Import | 10 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 244 |
| TCM | 58 |
| Therapeutic biologic | 38 |
| Biologic | 10 |
| Prophylactic biologic | 4 |
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
64 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Brexpiprazole Tablets | 8 | 3 | 31 |
| 2 | Flumazenil Injection | 3 | 1 | 2 |
| 3 | 地氯雷他定口服溶液 · No verified English name | 2 | 2 | 26 |
| 4 | Pranoprofen Eye Drops | 2 | 2 | 7 |
| 5 | 氟比洛芬凝胶贴膏 · No verified English name | 2 | 2 | 16 |
| 6 | Isavuconazonium Sulfate for Injection | 2 | 2 | 15 |
| 7 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
| 8 | Dapagliflozin Tablets | 2 | 2 | 84 |
| 9 | Bromhexine Hydrochloride Solution For Inhalation | 2 | 1 | 1 |
| 10 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 22 |
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
219 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 11 | 7 | 0 |
| 2 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized | 9 | 1 | 0 |
| 3 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Pfizer Inc. | 5 | 2 | 0 |
| 6 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 4 | 4 |
| 7 | Qinghai Lu Kang Da Di Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | AstraZeneca AB | 4 | 3 | 0 |
| 9 | Baxter Deutschland GmbH | 4 | 3 | 0 |
| 10 | Beijing Tai De Pharmaceutical Co., Ltd. romanized | 4 | 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
97 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/07/27Import · Class 2.2 | 阿替利珠单抗注射液(皮下注射) · No verified English nameJXSS2400064 | Roche Registration GmbH; Roche Diagnostics GmbH; Roche (China) Holding Ltd. |
| 2024/07/27Import · Class 3.1 | 阿替利珠单抗注射液(皮下注射) · No verified English nameJXSS2400063 | Roche Registration GmbH; Roche Diagnostics GmbH; Roche (China) Holding Ltd. |
| 2024/07/27Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2402382 | Zhejiang Nord Pharmaceutical Co., Ltd |
| 2024/07/27Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2402380 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized |
| 2024/07/27Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2402378 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized |
| 2024/07/27Generic · Class 3 | Epalrestat TabletsCYHS2402372 | Ningxia Kang Ya Pharma Co., Ltd. romanized |
| 2024/07/27New drug · Class 1.2 | ZY13提取物 · No verified English nameCXZL2400043 | Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2024/07/27New drug · Class 1.2 | ZY13片 · No verified English nameCXZL2400042 | Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2024/07/27New drug · Class 1.1 | 通塞颗粒 · No verified English nameCXZL2400041 | Henan Zhong Pharmaceuticals University romanized |
| 2024/07/27New drug · Class 2.2 | 依沃西单抗注射液 · No verified English nameCXSS2400080 | Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized; Kang Fang Pharma Co., Ltd. romanized |
| 2024/07/27New drug · Class 1 | 注射用SHR-9839 · No verified English nameCXSL2400491 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/07/27New drug · Class 1 | 注射用SHR-1826 · No verified English nameCXSL2400490 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/07/27New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2400489 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/07/27New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2400488 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/07/27New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2400487 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/07/27New drug · Class 1 | SHR-6934注射液 · No verified English nameCXSL2400486 | Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Mai Jin Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/07/27New drug · Class 1.3 | 四价流感病毒裂解疫苗(ZFA02佐剂) · No verified English nameCXSL2400485 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2024/07/27New drug · Class 1 | 注射用重组人源化抗BCMA/CD3双特异性抗体 · No verified English nameCXSL2400484 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2024/07/27New drug · Class 1 | 注射用AK138D1 · No verified English nameCXSL2400483 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2024/07/27New drug · Class 1 | POV-601-1A1溶瘤病毒注射液 · No verified English nameCXSL2400482 | Suzhou Bo Re Bio Technology Co., Ltd. romanized |
| 2024/07/27New drug · Class 2.2 | 棕榈酸帕利哌酮注射液(II) · No verified English nameCXHS2400066 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2024/07/27New drug · Class 2.2 | 棕榈酸帕利哌酮注射液(II) · No verified English nameCXHS2400065 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2024/07/27New drug · Class 2.2 | 棕榈酸帕利哌酮注射液(II) · No verified English nameCXHS2400064 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2024/07/27New drug · Class 2.2 | 棕榈酸帕利哌酮注射液(II) · No verified English nameCXHS2400063 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2024/07/27New drug · Class 2.2 | 棕榈酸帕利哌酮注射液(II) · No verified English nameCXHS2400062 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2024/07/27New drug · Class 2.2 | 棕榈酸帕利哌酮注射液(II) · No verified English nameCXHS2400061 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2024/07/27New drug · Class 1 | GTA182片 · No verified English nameCXHL2400763 | Shanghai Pai Long Bio Technology Co., Ltd. romanized |
| 2024/07/27New drug · Class 1 | GTA182片 · No verified English nameCXHL2400762 | Shanghai Pai Long Bio Technology Co., Ltd. romanized |
| 2024/07/27New drug · Class 1 | HRS-4642注射液 · No verified English nameCXHL2400761 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/07/27New drug · Class 2.2 | 布地奈德吸入喷雾剂 · No verified English nameCXHL2400760 | Zheng Da Tian Qing (Guangzhou) Pharmaceuticals Co., Ltd. romanized |
67 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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