YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 341 drug applications between 18 October 2024 and 24 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 88, covering 68 drug names.
2024/10/18 – 2024/10/24
- New acceptances this week
- 341
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- Accepted this week, now under review
- 1
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
341filings, 88 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 158 |
| Generic | 88 |
| New drug | 58 |
| Import | 23 |
| Unspecified | 12 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 194 |
| TCM | 78 |
| Therapeutic biologic | 50 |
| Prophylactic biologic | 10 |
| Biologic | 9 |
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
68 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Bumetanide Injection | 3 | 2 | 13 |
| 2 | 匹伐他汀钙口崩片 · No verified English name | 3 | 1 | 0 |
| 3 | Bilastine Oral Solution | 2 | 2 | 8 |
| 4 | Landiolol Hydrochloride for Injection | 2 | 2 | 19 |
| 5 | Lactulose Oral Solution | 2 | 1 | 34 |
| 6 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 7 | Perampanel Tablets | 2 | 1 | 2 |
| 8 | Olmesartan Medoxomil Orally Disintegrating Tablets | 2 | 1 | 0 |
| 9 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 10 | Levocarnitine Oral Solution | 2 | 1 | 9 |
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
214 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 2 | Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Eli Lilly and Company | 6 | 1 | 0 |
| 4 | Jilin Sheng Shang Cheng Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 5 | AstraZeneca AB | 5 | 3 | 0 |
| 6 | Novo Nordisk A/S | 5 | 1 | 0 |
| 7 | Sanofi-Aventis Recherche & Développement | 4 | 4 | 0 |
| 8 | Hua Chuan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Beijing Bai Yi Wu You Technology Development Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Bayer AG | 4 | 2 | 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
124 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/10/24Import · Class 1 | SAR442970注射液 · No verified English nameJXSL2400203 | Sanofi-aventis recherche & développement; Sanofi (China) Investment Co. Ltd. |
| 2024/10/24Import · Class 1 | SAR441566 · No verified English nameJXHL2400256 | Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd. |
| 2024/10/24Import · Class 1 | Rilzabrutinib片 · No verified English nameJXHL2400255 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2024/10/24Generic · Class 3 | Clemastine Fumarate InjectionCYHS2403599 | Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2024/10/24Generic · Class 3 | 托吡酯口服溶液 · No verified English nameCYHS2403596 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2024/10/24Generic · Class 3 | 枸橼酸西地那非口溶膜 · No verified English nameCYHS2403593 | Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized |
| 2024/10/24Generic · Class 3 | 枸橼酸西地那非口溶膜 · No verified English nameCYHS2403592 | Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized |
| 2024/10/24Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2403588 | Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2024/10/24Generic · Class 3 | 酮洛芬凝胶贴膏 · No verified English nameCYHS2403587 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/10/24Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2403585 | Hainan Wei Jian Pharma Co., Ltd. romanized; Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2024/10/24Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2403584 | Hainan Wei Jian Pharma Co., Ltd. romanized; Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2024/10/24Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHL2400210 | Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized |
| 2024/10/24New drug · Class 1.2 | 苦丁茶总皂苷提取物 · No verified English nameCXZL2400069 | Hua Yi Shen Nong (Zhuhai) Pharmaceuticals Technology Co., Ltd. romanized; Beijing University romanized; Chongqing Shi Zhong Yao Research Institute (Chongqing Shi Zhong Yao Bo Wu Guan) romanized |
| 2024/10/24New drug · Class 1.2 | 苦丁茶皂苷片 · No verified English nameCXZL2400068 | Hua Yi Shen Nong (Zhuhai) Pharmaceuticals Technology Co., Ltd. romanized; Beijing University romanized; Chongqing Shi Zhong Yao Research Institute (Chongqing Shi Zhong Yao Bo Wu Guan) romanized |
| 2024/10/24New drug · Class 1.1 | 膝痛颗粒 · No verified English nameCXZL2400067 | Zhong Yi (Guangzhou) Technology Innovation Research Co., Ltd. romanized; Zhongguo Zhong Yi Ke College Zhong Yao Research Institute romanized |
| 2024/10/24New drug · Class 3.3 | 流感病毒裂解疫苗 · No verified English nameCXSS2400114 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2024/10/24New drug · Class 2.2 | 拓培非格司亭注射液 · No verified English nameCXSL2400728 | Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized |
| 2024/10/24New drug · Class 1 | 注射用YK012 · No verified English nameCXSL2400727 | Yi Ke Si Te (Beijing) Pharmaceuticals Technology Development Co., Ltd. romanized |
| 2024/10/24New drug · Class 2.2 | 甲型肝炎灭活疫苗(人二倍体细胞) · No verified English nameCXSL2400726 | Zhejiang Pu Kang Bio Technology Co., Ltd. romanized |
| 2024/10/24New drug · Class 2.2 | 甲型肝炎灭活疫苗(人二倍体细胞) · No verified English nameCXSL2400725 | Zhejiang Pu Kang Bio Technology Co., Ltd. romanized |
| 2024/10/24New drug · Class 1 | 注射用MHB009C · No verified English nameCXSL2400724 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2024/10/24New drug · Class 1 | 注射用SLN12140 · No verified English nameCXSL2400723 | Ling Nuo (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/24New drug · Class 2.2 | JSS-221 · No verified English nameCXHL2401127 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2024/10/24New drug · Class 1 | WA01片 · No verified English nameCXHL2401126 | Nuo Wei Bio Technology (Wuxi) Co., Ltd. romanized; Nuo Wei Technology (Beijing) Co., Ltd. romanized |
| 2024/10/23Import · Class 1 | ADI-001 · No verified English nameJXSL2400202 | Adicet Therapeutics Inc.; Shanghai Adicet Biotechnology Co. Ltd. |
| 2024/10/23Import · Class 2.2 | 注射用Belantamab mafodotin · No verified English nameJXSL2400201 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. Limited |
| 2024/10/23Import · Class 1 | Itepekimab注射液 · No verified English nameJXSL2400200 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2024/10/23Import · Class 1 | Frexalimab注射液 · No verified English nameJXSL2400199 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2024/10/23Generic · Class 3 | Famotidine InjectionCYHS2403583 | Shi Yao Yin Hu Pharmaceutical Co., Ltd. romanized |
| 2024/10/23Generic · Class 3 | Methocarbamol InjectionCYHS2403582 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized |
94 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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