YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 391 drug applications between 24 April 2025 and 30 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 74 drug names.
2025/04/24 – 2025/04/30
- New acceptances this week
- 391
- Drugs with new generic filings (by drug name, de-duplicated)
- 74
- Accepted this week, now under review
- 44
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
391filings, 90 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 206 |
| Generic | 90 |
| New drug | 52 |
| Import | 24 |
| Unspecified | 12 |
| Import re-registration | 6 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 266 |
| TCM | 82 |
| Therapeutic biologic | 33 |
| Biologic | 5 |
| Prophylactic biologic | 5 |
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
74 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Pemafibrate Tablets | 4 | 4 | 23 |
| 2 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 3 | Ferrous Succinate Tablets | 2 | 2 | 20 |
| 4 | Eperisone Hydrochloride Tablets | 2 | 2 | 8 |
| 5 | Adapalene Gel | 2 | 2 | 30 |
| 6 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 7 | Dimethyl Fumarate Delayed-release Capsules | 2 | 1 | 0 |
| 8 | Tandospirone Citrate Tablets | 2 | 1 | 2 |
| 9 | 注射用头孢唑肟钠 · No verified English name | 2 | 1 | 4 |
| 10 | Levobupivacaine Hydrochloride Injection | 2 | 1 | 2 |
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
226 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 33 | 26 | 0 |
| 2 | Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | 16 | 10 | 0 |
| 3 | Dan Dong Hong Ye Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | Eli Lilly and Company | 8 | 2 | 0 |
| 5 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 5 | 4 | 4 |
| 10 | Janssen-Cilag International NV | 5 | 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
99 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/04/30Generic · Class 3 | Multiple Electrolytes and Sodium Acetate InjectionCYHS2501623 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/04/30Generic · Class 3 | Famotidine InjectionCYHS2501619 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2025/04/30Generic · Class 3 | Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2501617 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized |
| 2025/04/30New drug · Class 1 | 靶向CD19和CD22 的嵌合抗原受体自体T细胞注射液 · No verified English nameCXSL2500344 | Shanghai Pharmaceuticals Group Bio Zhi Liao Technology Co., Ltd. romanized |
| 2025/04/30New drug · Class 1 | 注射用YL242 · No verified English nameCXSL2500343 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2025/04/30New drug · Class 1 | DF-003胶囊 · No verified English nameCXHL2500428 | Shanghai Yao Yuan Bio Technology Co., Ltd. romanized |
| 2025/04/30New drug · Class 1 | DF-003胶囊 · No verified English nameCXHL2500427 | Shanghai Yao Yuan Bio Technology Co., Ltd. romanized |
| 2025/04/30New drug · Class 1 | DF-003胶囊 · No verified English nameCXHL2500426 | Shanghai Yao Yuan Bio Technology Co., Ltd. romanized |
| 2025/04/30New drug · Class 1 | G201-Na胶囊 · No verified English nameCXHL2500425 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2025/04/30New drug · Class 1 | G201-Na胶囊 · No verified English nameCXHL2500424 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2025/04/29Import · Class 1 | Mezagitamab注射剂 · No verified English nameJXSL2500067 | Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited |
| 2025/04/29Import · Class 1 | Mezagitamab注射剂 · No verified English nameJXSL2500066 | Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited |
| 2025/04/29Import · Class 1 | TQJ230注射液 · No verified English nameJXHL2500103 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/04/29Generic · Class 3 | Metaraminol Tartrate InjectionCYHS2501612 | Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized |
| 2025/04/29Generic · Class 3 | Potassium Phosphates InjectionCYHS2501611 | Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2025/04/29Generic · Class 3 | Bumetanide InjectionCYHS2501608 | Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/04/29Generic · Class 3 | Lidocaine Hydrochloride GelCYHS2501605 | Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2025/04/29Generic · Class 3 | Betahistine Dihydrochloride TabletsCYHS2501601 | Jin Zhou Jiu Tai Pharma Co., Ltd. romanized |
| 2025/04/29Generic · Class 3 | 小儿多种维生素注射液(13) · No verified English nameCYHS2501600 | Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2025/04/29Generic · Class 3 | Spironolactone Oral SuspensionCYHS2501599 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized |
| 2025/04/29New drug · Class 2.1 | TFA003片 · No verified English nameCXZL2500028 | Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2025/04/29New drug · Class 1 | BBT001注射液 · No verified English nameCXSL2500342 | Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/04/29New drug · Class 1 | NouvNeu004 · No verified English nameCXSL2500341 | Rui Jian Yi Lian Pharmaceuticals Technology (Chengdu) Co., Ltd. romanized; Rui Jian Pharmaceuticals Technology (Wuhan) Co., Ltd. romanized |
| 2025/04/29New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2500340 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/04/29New drug · Class 1 | IMD101 注射液 · No verified English nameCXSL2500339 | Shanghai Ying Mai De Medical Technology Co., Ltd. romanized |
| 2025/04/29New drug · Class 1 | 索托克拉片 · No verified English nameCXHS2500043 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/04/28Import · Class 3.1 | 帕博利珠单抗注射液 · No verified English nameJXSS2500051 | Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2025/04/28Import · Class 1 | VHB937注射用浓溶液 · No verified English nameJXSL2500065 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/04/28Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2501595 | Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/04/28Generic · Class 3 | 富马酸氯马斯汀口服溶液 · No verified English nameCYHS2501592 | Guangdong Hua Nan Pharma Group Co., Ltd. romanized; Guangdong Zhong Sheng Pharma Co., Ltd. romanized |
69 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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