YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 416 drug applications between 8 August 2025 and 14 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 131, covering 84 drug names.
2025/08/08 – 2025/08/14
- New acceptances this week
- 416
- Drugs with new generic filings (by drug name, de-duplicated)
- 84
- Accepted this week, now under review
- 113
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
416filings, 131 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 172 |
| Generic | 131 |
| New drug | 65 |
| Import | 22 |
| Unspecified | 19 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 280 |
| Therapeutic biologic | 64 |
| TCM | 62 |
| Biologic | 7 |
| Prophylactic biologic | 3 |
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
84 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 6 | 3 | 70 |
| 2 | Azilsartan Medoxomil Potassium Tablets | 4 | 2 | 35 |
| 3 | 苯磺酸左氨氯地平片 · No verified English name | 4 | 2 | 45 |
| 4 | 替尔泊肽注射液 · No verified English name | 4 | 1 | 22 |
| 5 | Baricitinib Tablets | 3 | 2 | 32 |
| 6 | Finerenone Tablets | 3 | 2 | 69 |
| 7 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English name | 3 | 1 | 7 |
| 8 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English name | 3 | 1 | 7 |
| 9 | 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English name | 3 | 1 | 7 |
| 10 | 中性腹膜透析液(碳酸氢盐-G2.5%) · 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
225 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 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 10 | 4 | 0 |
| 5 | AstraZeneca AB | 9 | 4 | 0 |
| 6 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 7 | 5 | 4 |
| 7 | Qilu Pharmaceutical Co., Ltd. | 7 | 5 | 0 |
| 8 | Henan Ling Rui Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 9 | Hua Run Zi Zhu Pharma Co., Ltd. romanized | 6 | 4 | 0 |
| 10 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 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
143 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/08/14Import · Class 2.2 | 注射用替奈普酶 · No verified English nameJXSL2500155 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2025/08/14Import · Class 1 | AZD0486 · No verified English nameJXSL2500154 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/14Import · Class 1 | AZD0486 · No verified English nameJXSL2500153 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/14Import · Class 1 | AZD0486 · No verified English nameJXSL2500152 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/14Import · Class 1 | AZD0486 · No verified English nameJXSL2500151 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/14Import · Class 1 | AZD0486 · No verified English nameJXSL2500150 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/14Import · Class 1 | BCD-261注射液 · No verified English nameJXSL2500149 | SPH-BIOCAD (HK) LIMITED; SPH-BIOCAD Biopharmaceuticals (SH) Co. Ltd. |
| 2025/08/14Import · Class 1 | MEDI5752 · No verified English nameJXSL2500148 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/14Generic · Class 3 | Folic Acid TabletsCYHS2502979 | Jian Chang Bang Pharma Co., Ltd. romanized; Beijing Si Li An Pharma Co., Ltd. romanized |
| 2025/08/14Generic · Class 3 | Folic Acid TabletsCYHS2502973 | Chengdu Tong De Pharma Co., Ltd. romanized |
| 2025/08/14Generic · Class 3 | 枸橼酸苯海拉明布洛芬片 · No verified English nameCYHS2502972 | Hefei En Rui Te Pharma Co., Ltd. romanized |
| 2025/08/14Generic · Class 3 | Doxycycline Hyclate TabletsCYHS2502969 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/08/14Generic · Class 3 | Doxycycline Hyclate TabletsCYHS2502968 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/08/14Generic · Class 3 | 瑞舒伐他汀钙口崩片 · No verified English nameCYHS2502966 | Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2025/08/14Generic · Class 3 | 瑞舒伐他汀钙口崩片 · No verified English nameCYHS2502965 | Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2025/08/14Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2502963 | Guo Yao Group Guo Rui Pharma Co., Ltd. romanized |
| 2025/08/14Generic · Class 3 | Isosulfan Blue InjectionCYHL2500146 | Kang Zhe (Hunan) Pharmaceutical Co., Ltd. romanized |
| 2025/08/14Generic · Class 3 | 盐酸羟甲唑啉滴眼液 · No verified English nameCYHL2500145 | Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized |
| 2025/08/14New drug · Class 1 | AZD0901 · No verified English nameCXSL2500694 | A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized |
| 2025/08/14New drug · Class 2.3 | HY22017胶囊 · No verified English nameCXHS2500095 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2025/08/14New drug · Class 1 | HRS-6209胶囊 · No verified English nameCXHL2500848 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/14New drug · Class 1 | HRS-6209胶囊 · No verified English nameCXHL2500847 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/14New drug · Class 1 | HRS-6209胶囊 · No verified English nameCXHL2500846 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/14New drug · Class 1 | HRS-6209胶囊 · No verified English nameCXHL2500845 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/14New drug · Class 1 | HRS-2189片 · No verified English nameCXHL2500844 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/08/14New drug · Class 1 | HRS-2189片 · No verified English nameCXHL2500843 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/08/14New drug · Class 2.4 | 阿贝西利片 · No verified English nameCXHL2500842 | Qilu Pharmaceutical Co., Ltd. |
| 2025/08/14New drug · Class 2.4 | 阿贝西利片 · No verified English nameCXHL2500841 | Qilu Pharmaceutical Co., Ltd. |
| 2025/08/14New drug · Class 2.4 | 阿贝西利片 · No verified English nameCXHL2500840 | Qilu Pharmaceutical Co., Ltd. |
| 2025/08/14New drug · Class 2.2 | 紫杉醇软胶囊 · No verified English nameCXHL2500839 | Mei Ji Biopharmaceuticals (Guangzhou) Co., Ltd. romanized |
113 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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