YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 278 drug applications between 27 April 2025 and 3 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 54 drug names.
2025/04/27 – 2025/05/03
- New acceptances this week
- 278
- Drugs with new generic filings (by drug name, de-duplicated)
- 54
- Accepted this week, now under review
- 28
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
278filings, 58 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 146 |
| Generic | 58 |
| New drug | 52 |
| Import | 9 |
| Unspecified | 6 |
| Import re-registration | 6 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 172 |
| TCM | 66 |
| Therapeutic biologic | 34 |
| Biologic | 5 |
| Prophylactic biologic | 1 |
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
54 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 二甲双胍恩格列净片(Ⅰ) · No verified English name | 2 | 2 | 7 |
| 2 | 盐酸米诺环素泡沫剂 · No verified English name | 2 | 2 | 0 |
| 3 | Adapalene Gel | 2 | 2 | 30 |
| 4 | 注射用头孢唑肟钠 · No verified English name | 2 | 1 | 4 |
| 5 | Lactated Ringer's Injection | 1 | 1 | 5 |
| 6 | Ethyl Iosapentate Capsules | 1 | 1 | 27 |
| 7 | Pemafibrate Tablets | 1 | 1 | 23 |
| 8 | 倍氯米松福莫特罗吸入气雾剂 · No verified English name | 1 | 1 | 0 |
| 9 | Lidocaine and Prilocaine Cream | 1 | 1 | 24 |
| 10 | Pinaverium Bromide Tablets | 1 | 1 | 5 |
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
161 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 41 | 34 | 0 |
| 2 | Janssen-Cilag International NV | 8 | 3 | 0 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 4 | Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Guangdong Sunho Pharmaceutical Co., Ltd. | 5 | 1 | 0 |
| 6 | Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized | 4 | 3 | 4 |
| 9 | Takeda Development Center Americas Inc. | 4 | 2 | 0 |
| 10 | Nanjing Yu Xi Pharmaceuticals Technology Co., Ltd. romanized | 4 | 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
76 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/01Import · Class 1 | 177Lu-HuJ591单抗注射液 · No verified English nameJXSL2500069 | Telix Pharmaceuticals (Innovations) Pty Ltd; GrandPharma (China) Co. Ltd. |
| 2025/05/01Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2501638 | Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized |
| 2025/05/01Generic · Class 3 | Meloxicam injectionCYHS2501635 | Zhejiang Sheng Zhao Drug Technology Co., Ltd. romanized; Hangzhou Ao Ya Bio Technology Co., Ltd. romanized |
| 2025/05/01Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2501634 | Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2025/05/01New drug · Class 1 | FL115注射液 · No verified English nameCXSL2500350 | Suzhou Fu Rong Bio Technology Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | BAT4406F注射液 · No verified English nameCXSL2500349 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2500348 | Shenzhen Shi Bei Ke Bio Technology Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | 注射用BGB-B3227 · No verified English nameCXSL2500347 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | 注射用重组病毒巨噬细胞炎性蛋白 · No verified English nameCXSL2500346 | Guangzhou Hong Run Bio Technology Co., Ltd. romanized |
| 2025/05/01New drug · Class 2.2 | 依沃西单抗注射液 · No verified English nameCXSL2500345 | Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | 注射用HRS8179 · No verified English nameCXHL2500436 | Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | MDI-1228_mesylate凝胶 · No verified English nameCXHL2500435 | Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | MDI-1228_mesylate凝胶 · No verified English nameCXHL2500434 | Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | MDI-1228_mesylate凝胶 · No verified English nameCXHL2500433 | Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | MDI-1228_mesylate凝胶 · No verified English nameCXHL2500432 | Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | HRS-1893片 · No verified English nameCXHL2500431 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | SYN608片 · No verified English nameCXHL2500430 | Hangzhou Sheng Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | SYN608片 · No verified English nameCXHL2500429 | Hangzhou Sheng Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 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 |
46 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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