YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 394 drug applications between 7 August 2025 and 13 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 118, covering 77 drug names.
2025/08/07 – 2025/08/13
- New acceptances this week
- 394
- Drugs with new generic filings (by drug name, de-duplicated)
- 77
- Accepted this week, now under review
- 109
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
394filings, 118 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 177 |
| Generic | 118 |
| New drug | 64 |
| Import | 16 |
| Unspecified | 11 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 258 |
| Therapeutic biologic | 64 |
| TCM | 63 |
| Biologic | 5 |
| 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
77 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Azilsartan Medoxomil Potassium Tablets | 4 | 2 | 35 |
| 2 | 苯磺酸左氨氯地平片 · No verified English name | 4 | 2 | 45 |
| 3 | 替尔泊肽注射液 · No verified English name | 4 | 1 | 22 |
| 4 | 瑞维那新吸入溶液 · No verified English name | 3 | 3 | 53 |
| 5 | Baricitinib Tablets | 3 | 2 | 32 |
| 6 | Sacubitril Valsartan Sodium Tablets | 3 | 2 | 70 |
| 7 | Finerenone Tablets | 3 | 2 | 69 |
| 8 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English name | 3 | 1 | 7 |
| 9 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English name | 3 | 1 | 7 |
| 10 | 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English name | 3 | 1 | 7 |
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 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized | 18 | 6 | 12 |
| 2 | Shen Yao He Ze Pharma (Shandong) Co., Ltd. romanized | 15 | 6 | 0 |
| 3 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 10 | 8 | 0 |
| 4 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 7 | 5 | 4 |
| 5 | Henan Ling Rui Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 7 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Shanxi Zheng Lai Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 9 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Terumo Corporation Kofu Factory | 5 | 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
128 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/08/13Import · Class 2.2 | DS-1062a · No verified English nameJXSL2500147 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/08/13Import · Class 1 | Lunsekimig注射液 · No verified English nameJXSL2500146 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/08/13Import · Class 1 | Lunsekimig注射液 · No verified English nameJXSL2500145 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/08/13Import · Class 1 | 乙磺酸LY4066434片 · No verified English nameJXHL2500216 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/13Import · Class 1 | 乙磺酸LY4066434片 · No verified English nameJXHL2500215 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/13Import · Class 1 | 乙磺酸LY4066434片 · No verified English nameJXHL2500214 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/13Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2502957 | Hubei Wu Shi Pharma Co., Ltd. romanized |
| 2025/08/13Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2502955 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/08/13Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2502954 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/08/13Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2502953 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/08/13Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502952 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/08/13Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502951 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/08/13Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502950 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/08/13Generic · Class 3 | Phosribbon combination granulesCYHS2502947 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/08/13Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2502944 | Zhejiang Ling Chuang You Pin Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/08/13Generic · Class 3 | 维生素B12注射液 · No verified English nameCYHS2502943 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/08/13New drug · Class 3.2 | 贝伐珠单抗眼内注射液 · No verified English nameCXSS2500082 | Zhuhai Yi Sheng Biopharmaceutical Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2025/08/13New drug · Class 3.3 | QL2302注射液 · No verified English nameCXSL2500693 | Qilu Pharmaceutical Co., Ltd. |
| 2025/08/13New drug · Class 3.3 | 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2500692 | Chengdu Kang Hua Bio Zhi Pin Co., Ltd. romanized |
| 2025/08/13New drug · Class 2.4; 2.2 | PRT-062鼻喷雾剂 · No verified English nameCXHL2500838 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2025/08/13New drug · Class 2.4; 2.2 | PRT-062鼻喷雾剂 · No verified English nameCXHL2500837 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2025/08/12Import · Class 2.1 | 艾沙妥昔单抗注射液(皮下注射) · No verified English nameJXSS2500108 | Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH |
| 2025/08/12Import · Class 1 | 注射用SAR446523 · No verified English nameJXSL2500144 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/08/12Generic · Class 3 | Sodium Cromoglicate Eye DropsCYHS2502936 | Suzhou Le Zhu Pharmaceutical Co., Ltd. romanized |
| 2025/08/12Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502930 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/08/12Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502929 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/08/12Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502928 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/08/12Generic · Class 3 | 磷/碳酸氢钠血滤置换液(4mmol/L钾、1.25mmol/L钙) · No verified English nameCYHS2502922 | Ningbo Tian Yi Pharma Technology Co., Ltd. romanized |
| 2025/08/12Generic · Class 3 | Peramivir InjectionCYHS2502916 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2025/08/12Generic · Class 3 | 甲磺酸酚妥拉明滴眼液 · No verified English nameCYHL2500143 | Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized |
98 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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