YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 388 drug applications between 23 April 2025 and 29 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 73 drug names.
2025/04/23 – 2025/04/29
- New acceptances this week
- 388
- Drugs with new generic filings (by drug name, de-duplicated)
- 73
- Accepted this week, now under review
- 43
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
388filings, 93 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 189 |
| Generic | 93 |
| New drug | 54 |
| Import | 34 |
| Unspecified | 10 |
| Import re-registration | 6 |
| Drug-device combination | 1 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 277 |
| TCM | 66 |
| Therapeutic biologic | 36 |
| Prophylactic biologic | 6 |
| 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
73 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Pemafibrate Tablets | 5 | 5 | 23 |
| 2 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 3 | Diclofenac Diethylamine Emulgel | 2 | 2 | 20 |
| 4 | Ferrous Succinate Tablets | 2 | 2 | 20 |
| 5 | Eperisone Hydrochloride Tablets | 2 | 2 | 8 |
| 6 | Adapalene Gel | 2 | 2 | 30 |
| 7 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 8 | Dimethyl Fumarate Delayed-release Capsules | 2 | 1 | 0 |
| 9 | Tandospirone Citrate Tablets | 2 | 1 | 2 |
| 10 | 注射用头孢唑肟钠 · No verified English name | 2 | 1 | 4 |
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 | Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | 16 | 10 | 0 |
| 2 | Eli Lilly and Company | 14 | 2 | 0 |
| 3 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 13 | 9 | 0 |
| 4 | Janssen-Cilag International NV | 9 | 4 | 0 |
| 5 | Dan Dong Hong Ye Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 6 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 6 | 3 | 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 | Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized | 4 | 4 | 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
113 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2025/04/28Generic · Class 3 | Benzbromarone TabletsCYHS2501591 | Zhejiang Jiang Bei Pharma Co., Ltd. romanized |
| 2025/04/28Generic · Class 3 | Ferrous Succinate TabletsCYHS2501589 | Shaanxi Ju Cheng Biopharmaceuticals Manufacturing Li Cu Jin Center Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/04/28Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2501587 | Ao Nuo (Zhongguo) Pharmaceutical Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.3 | 百令胶囊 · No verified English nameCXZL2500027 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.3 | 百令胶囊 · No verified English nameCXZL2500026 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2500338 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/04/28New drug · Class 1 | 注射用DB-1311 · No verified English nameCXSL2500337 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2500336 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2500335 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/04/28New drug · Class 1 | 注射用SKB518 · No verified English nameCXSL2500334 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
83 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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