YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 431 drug applications between 7 September 2024 and 13 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 132, covering 92 drug names.
2024/09/07 – 2024/09/13
- New acceptances this week
- 431
- Drugs with new generic filings (by drug name, de-duplicated)
- 92
- Accepted this week, now under review
- 6
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
431filings, 132 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 206 |
| Generic | 132 |
| New drug | 81 |
| Import | 5 |
| Import re-registration | 4 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 308 |
| TCM | 67 |
| Therapeutic biologic | 51 |
| Prophylactic biologic | 3 |
| In vitro diagnostic reagent | 1 |
| Biologic | 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
92 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Levocetirizine dihydrochloride Oral Solution | 5 | 2 | 5 |
| 2 | Nicardipine Hydrochloride Injection | 4 | 2 | 13 |
| 3 | Lactulose Oral Solution | 3 | 2 | 34 |
| 4 | Trazodone Hydrochloride Tablets | 3 | 2 | 5 |
| 5 | Sodium Bicarbonate Injection | 3 | 2 | 10 |
| 6 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 7 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 8 | Erythromycin Lactobionate for Injection | 3 | 1 | 13 |
| 9 | 注射用头孢唑肟钠 · No verified English name | 3 | 1 | 4 |
| 10 | Acetylcysteine Solution For Inhalation | 2 | 2 | 4 |
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
257 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Xin Wan Lian Pharmaceuticals Co., Ltd. romanized | 30 | 29 | 0 |
| 2 | Gan Li Pharma Shandong Co., Ltd. romanized | 8 | 1 | 0 |
| 3 | Celgene Corporation | 6 | 1 | 0 |
| 4 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Suzhou Pai Rui Bio Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 6 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 7 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 8 | Hua Run Shuang He Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Xian Zi Li Pharmaceutical Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 4 | 3 | 1 |
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
145 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/13Import · Class 3.1 | 20价肺炎球菌多糖结合疫苗 · No verified English nameJXSL2400166 | Pfizer Europe MA EEIG; Pfizer Investment CO. Ltd. |
| 2024/09/13Generic · Class 3 | Fat-Soluble Vitamin Injection(Ⅰ)CYHS2403071 | Shenyang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2024/09/13Generic · Class 3 | Loxoprofen Sodium Oral SolutionCYHS2403070 | Nanjing Hai Jing Pharma Co., Ltd. romanized |
| 2024/09/13Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2403069 | Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/09/13Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2403068 | Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/09/13Generic · Class 3 | Famotidine InjectionCYHS2403065 | Zhuhai Heng Qin Guo Yan Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2024/09/13Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2403064 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2024/09/13Generic · Class 3 | Minoxidil LinimentCYHS2403058 | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized |
| 2024/09/13Generic · Class 3 | Minoxidil LinimentCYHS2403057 | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized |
| 2024/09/13Generic · Class 3 | Pregabalin Orally Disintegrating TabletsCYHS2403056 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2024/09/13Generic · Class 3 | Pregabalin Orally Disintegrating TabletsCYHS2403055 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2024/09/13New drug · Class 1 | TAEST16001注射液 · No verified English nameCXSL2400618 | Xiang Xue Sheng Ming Ke Xue Technology (Guangdong) Co., Ltd. romanized |
| 2024/09/13New drug · Class 1 | EMB-09注射液 · No verified English nameCXSL2400617 | Shanghai An Mai Bio Technology Co., Ltd. romanized |
| 2024/09/13New drug · Class 2.2 | 恩朗苏拜单抗注射液 · No verified English nameCXSL2400616 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2024/09/13New drug · Class 1 | 外用RGL-2102 · No verified English nameCXSL2400615 | Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized; Guangzhou Rui Ling Pharmaceuticals Co., Ltd. romanized |
| 2024/09/13New drug · Class 1 | RG002注射液 · No verified English nameCXSL2400614 | Ren Jing (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/09/13New drug · Class 1 | 注射用BL-M08D1 · No verified English nameCXSL2400613 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2024/09/13New drug · Class 1 | 注射用SKB501 · No verified English nameCXSL2400612 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2024/09/13New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHL2400966 | Shenzhen Shi Yu Jian Biopharmaceuticals Co., Ltd. romanized |
| 2024/09/13New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHL2400965 | Shenzhen Shi Yu Jian Biopharmaceuticals Co., Ltd. romanized |
| 2024/09/13New drug · Class 1 | SZ2726片 · No verified English nameCXHL2400964 | Su Zhong Pharma Group Co., Ltd. romanized; Jiangsu Su Zhong Pharma Research Institute Co., Ltd. romanized |
| 2024/09/13New drug · Class 1 | SZ2726片 · No verified English nameCXHL2400963 | Su Zhong Pharma Group Co., Ltd. romanized; Jiangsu Su Zhong Pharma Research Institute Co., Ltd. romanized |
| 2024/09/13New drug · Class 1 | SYHA1813口服溶液 · No verified English nameCXHL2400962 | Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/13New drug · Class 1 | SYHA1813口服溶液 · No verified English nameCXHL2400961 | Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/13New drug · Class 1 | SYHA1813口服溶液 · No verified English nameCXHL2400960 | Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/13New drug · Class 2.3 | SMF-203 · No verified English nameCXHL2400959 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2024/09/13New drug · Class 1 | 普那布林注射用浓溶液 · No verified English nameCXHL2400958 | Da Lian Wan Chun Bu Lin Pharmaceuticals Co., Ltd. romanized |
| 2024/09/13New drug · Class 1 | JMKX004649片 · No verified English nameCXHL2400957 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2024/09/13New drug · Class 1 | JMKX004649片 · No verified English nameCXHL2400956 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2024/09/12Import · Class 1 | AZD2936 · No verified English nameJXSL2400165 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
115 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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