YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 351 drug applications between 27 July 2024 and 2 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 70 drug names.
2024/07/27 – 2024/08/02
- New acceptances this week
- 351
- Drugs with new generic filings (by drug name, de-duplicated)
- 70
- Accepted this week, now under review
- 13
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
351filings, 96 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 162 |
| Generic | 96 |
| New drug | 72 |
| Import | 11 |
| Unspecified | 7 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 238 |
| Therapeutic biologic | 54 |
| TCM | 51 |
| Prophylactic biologic | 6 |
| Biologic | 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
70 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Isavuconazonium Sulfate for Injection | 4 | 4 | 15 |
| 2 | Trazodone Hydrochloride Tablets | 3 | 2 | 5 |
| 3 | Bromhexine Hydrochloride Oral Solution | 3 | 2 | 22 |
| 4 | Neostigmine Methylsulfate Injection | 3 | 1 | 4 |
| 5 | Magnesium Sulfate Injection | 3 | 1 | 7 |
| 6 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 7 | Pediatric Faropenem Sodium Granules | 2 | 2 | 2 |
| 8 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
| 9 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 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
220 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ha Yao Group Pharmaceutical Factory romanized | 11 | 2 | 0 |
| 2 | Hunan San Xue Pharma Co., Ltd. romanized | 9 | 7 | 0 |
| 3 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Shen Wei Pharma Group Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | AstraZeneca AB | 5 | 3 | 0 |
| 7 | Guangdong Ke Hong Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Qinghai Lu Kang Da Di Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized | 4 | 2 | 3 |
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
120 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/08/02Import · Class 3.1 | elranatamab · No verified English nameJXSL2400140 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2024/08/02Import · Class 3.1 | 注射用sotatercept · No verified English nameJXSL2400139 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2024/08/02Import · Class 3.1 | 注射用sotatercept · No verified English nameJXSL2400138 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2024/08/02Generic · Class 3 | Foscarnet Sodium InjectionCYHS2402461 | Chi Feng Yuan Sheng Pharma Co., Ltd. romanized |
| 2024/08/02Generic · Class 3 | Amisulpride Oral SolutionCYHS2402458 | Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized |
| 2024/08/02Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2402451 | Beijing SL Pharmaceutical Co., Ltd. |
| 2024/08/02Generic · Class 3 | 布美他尼片 · No verified English nameCYHS2402450 | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2024/08/02New drug · Class 1.2 | 冻干带状疱疹mRNA疫苗 · No verified English nameCXSL2400514 | Wuhan Rui Ji Bio Technology Co., Ltd. romanized; Shenzhen Rui Ji Bio Technology Co., Ltd. romanized |
| 2024/08/02New drug · Class 1 | IHS002赋能人脐带间充质干细胞注射液 · No verified English nameCXSL2400513 | Wuxi Hua Tai Innovation Yao Technology Research Institute Co., Ltd. romanized |
| 2024/08/02New drug · Class 1.2 | LVRNA007 · No verified English nameCXSL2400512 | Zhuhai Li Fan Da Bio Technology Co., Ltd. romanized |
| 2024/08/02New drug · Class 1 | SYS6020注射液 · No verified English nameCXSL2400511 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2024/08/02New drug · Class 1 | LM-108 注射液 · No verified English nameCXSL2400510 | Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2024/08/02New drug · Class 1 | 注射用肿瘤特异性重组IL-12 Fc融合蛋白 · No verified English nameCXSL2400509 | Beijing Kang Kang Bio Technology Co., Ltd. romanized; Shanghai Kang Kang Bio Technology Co., Ltd. romanized |
| 2024/08/02New drug · Class 1 | SON-DP注射液 · No verified English nameCXSL2400508 | Suzhou Fu En Te Pharma Co., Ltd. romanized |
| 2024/08/02New drug · Class 2.2 | 贝莫苏拜单抗注射液 · No verified English nameCXSL2400507 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2024/08/02New drug · Class 1 | 注射用CIGB-814 · No verified English nameCXHL2400775 | Shandong Lukang Pharmaceutical Co.,Ltd. |
| 2024/08/02New drug · Class 1 | ISM6331胶囊 · No verified English nameCXHL2400774 | Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized |
| 2024/08/02New drug · Class 1 | HW211026软膏 · No verified English nameCXHL2400773 | Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized |
| 2024/08/02New drug · Class 1 | ISM6331胶囊 · No verified English nameCXHL2400772 | Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized |
| 2024/08/02New drug · Class 1 | HW211026软膏 · No verified English nameCXHL2400771 | Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized |
| 2024/08/02New drug · Class 1 | ISM6331胶囊 · No verified English nameCXHL2400770 | Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized |
| 2024/08/01Import · Class 1 | JNJ-80948543注射液(静脉输注) · No verified English nameJXSL2400137 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/08/01Import · Class 1 | JNJ-80948543注射液(静脉输注) · No verified English nameJXSL2400136 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/08/01Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2402447 | Shanxi Hui Da Lin Xi Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2024/08/01Generic · Class 3 | Esketamine Hydrochloride InjectionCYHS2402446 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2024/08/01Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2402443 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized |
| 2024/08/01Generic · Class 3 | Chlorphenamine Maleate InjectionCYHS2402442 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2024/08/01Generic · Class 3 | Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2402438 | Hong He Pharmaceutical Co., Ltd. romanized |
| 2024/08/01Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2402433 | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2024/08/01New drug · Class 2.2 | 贝莫苏拜单抗注射液 · No verified English nameCXSS2400082 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
90 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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