YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 440 drug applications between 25 September 2025 and 1 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 72 drug names.
2025/09/25 – 2025/10/01
- New acceptances this week
- 440
- Drugs with new generic filings (by drug name, de-duplicated)
- 72
- Accepted this week, now under review
- 106
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
440filings, 93 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 216 |
| Generic | 93 |
| New drug | 84 |
| Import | 27 |
| Import re-registration | 15 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 245 |
| TCM | 97 |
| Therapeutic biologic | 94 |
| Unspecified | 2 |
| Prophylactic 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
72 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 2 | Ezetimibe and Atorvastatin Calcium Tablets(II) | 2 | 2 | 9 |
| 3 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 4 | Arginine and Ibuprofen Granules | 2 | 2 | 11 |
| 5 | 蒙脱石混悬液 · No verified English name | 2 | 2 | 31 |
| 6 | Acetylcysteine Granules | 2 | 1 | 4 |
| 7 | Tacrolimus Ointment | 2 | 1 | 6 |
| 8 | Ezetimibe and Atorvastatin Calcium Trihydrate Tablets | 2 | 1 | 4 |
| 9 | Carboplatin Injection | 2 | 1 | 10 |
| 10 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
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
273 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized | 13 | 13 | 0 |
| 2 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 7 | 6 | 0 |
| 3 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 7 | 5 | 0 |
| 4 | Otsuka Pharmaceutical Co.,Ltd. | 6 | 1 | 0 |
| 5 | AstraZeneca AB | 5 | 4 | 0 |
| 6 | Jilin Sheng Qi Ke Pharma Co., Ltd. romanized | 5 | 3 | 0 |
| 7 | Shandong Qidu Pharmaceutical Co., Ltd. | 5 | 2 | 2 |
| 8 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 9 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized | 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
129 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/10/01Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2503595 | Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2025/10/01New drug · Class 2.3 | 荆防合剂 · No verified English nameCXZL2500092 | Lu Nan Hou Pu Pharmaceutical Co., Ltd. romanized |
| 2025/10/01New drug · Class 1 | 瑞西奇拜单抗注射液 · No verified English nameCXSS2500106 | Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Zhejiang Hua Hai Bio Technology Co., Ltd. romanized |
| 2025/10/01New drug · Class 1 | XLS-103注射液 · No verified English nameCXSL2500857 | Xiang Xue Sheng Ming Ke Xue Technology (Guangdong) Co., Ltd. romanized |
| 2025/10/01New drug · Class 1 | XLS-103注射液 · No verified English nameCXSL2500856 | Xiang Xue Sheng Ming Ke Xue Technology (Guangdong) Co., Ltd. romanized |
| 2025/10/01New drug · Class 1 | 注射用YB-01 · No verified English nameCXSL2500855 | Yuan Ben (Zhuhai Heng Qin) Bio Technology Co., Ltd. romanized |
| 2025/09/30Import · Class 1 | MK-1084片 · No verified English nameJXHL2500304 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2025/09/30Import · Class 1 | MK-1084片 · No verified English nameJXHL2500303 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2025/09/30Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2503584 | Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2025/09/30Generic · Class 3 | Bumetanide InjectionCYHS2503579 | Shandong Yi Jian Pharma Co., Ltd. romanized |
| 2025/09/30Generic · Class 3 | Bumetanide InjectionCYHS2503578 | Shandong Yi Jian Pharma Co., Ltd. romanized |
| 2025/09/30New drug · Class 1.1 | 精芪化浊颗粒 · No verified English nameCXZL2500091 | Heilongjiang Sheng Ji Ren Pharma Co., Ltd. romanized |
| 2025/09/30New drug · Class 3.2 | 尼妥珠单抗注射液 · No verified English nameCXSS2500105 | Bai Tai Bio Pharma Co., Ltd. romanized |
| 2025/09/30New drug · Class 2.2 | 注射用卡瑞利珠单抗 · No verified English nameCXSS2500104 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/30New drug · Class 1 | 伊立芙普α眼内注射液 · No verified English nameCXSS2500103 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2025/09/30New drug · Class 1 | HY001N细胞注射液 · No verified English nameCXSL2500854 | He Yuan Bio Technology (Tianjin) Co., Ltd. romanized; Guangdong He Yuan Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/30New drug · Class 1 | 注射用TQB2102 · No verified English nameCXSL2500853 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/09/30New drug · Class 1 | 注射用BG-C137 · No verified English nameCXSL2500852 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2025/09/30New drug · Class 1 | TQB2930注射液 · No verified English nameCXSL2500851 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/09/30New drug · Class 1 | TQB2930注射液 · No verified English nameCXSL2500850 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/09/30New drug · Class 2.4 | 苹果酸法米替尼胶囊 · No verified English nameCXHS2500122 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/09/30New drug · Class 2.4 | GEN-725片 · No verified English nameCXHL2501058 | Henan Zhen Shi Bio Technology Co., Ltd. romanized |
| 2025/09/30New drug · Class 2.4 | GEN-725片 · No verified English nameCXHL2501057 | Henan Zhen Shi Bio Technology Co., Ltd. romanized |
| 2025/09/29Import · Class 1 | 注射用MK-2400 · No verified English nameJXSL2500192 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2025/09/29Import · Class 1 | 注射用MK-6070 · No verified English nameJXSL2500191 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2025/09/29Import · Class 1 | NNC6019-0001注射液 · No verified English nameJXSL2500190 | Novo Nordisk A/S; ICON Clinical Research (Beijing No. 2) Co. Ltd. |
| 2025/09/29Generic · Class 3 | 布比卡因脂质体注射液 · No verified English nameCYHS2503587 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2025/09/29Generic · Class 3 | 布比卡因脂质体注射液 · No verified English nameCYHS2503586 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2025/09/29Generic · Class 3 | Furosemide TabletsCYHS2503564 | Hai Hong Heng Long (Hainan) Bio Technology Co., Ltd. romanized; Jiangsu Yun Yang Group Pharma Co., Ltd. romanized |
| 2025/09/29Generic · Class 3 | Fluocinolone Acetonide,Hydroquinone And Tretinoin CreamCYHL2500175 | Zhejiang AngLiKang Pharmaceutical CO.,LTD. |
99 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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