YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 335 drug applications between 2 July 2025 and 8 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 66 drug names.
2025/07/02 – 2025/07/08
- New acceptances this week
- 335
- Drugs with new generic filings (by drug name, de-duplicated)
- 66
- Accepted this week, now under review
- 75
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
335filings, 96 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 145 |
| Generic | 96 |
| New drug | 70 |
| Import | 18 |
| Import re-registration | 4 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 229 |
| Therapeutic biologic | 53 |
| TCM | 50 |
| 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
66 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 瑞维那新吸入溶液 · No verified English name | 6 | 6 | 53 |
| 2 | Dapoxetine Hydrochloride Tablets | 4 | 2 | 20 |
| 3 | Acetylcysteine Injection | 3 | 3 | 53 |
| 4 | Cefazolin Sodium for Injection | 3 | 1 | 13 |
| 5 | Acyclovir Tablets | 3 | 1 | 6 |
| 6 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 7 | Iguratimod Tablets | 2 | 2 | 23 |
| 8 | 蔗糖羟基氧化铁咀嚼片 · No verified English name | 2 | 2 | 0 |
| 9 | Finerenone Tablets | 2 | 2 | 69 |
| 10 | 依伏卡塞片 · No verified English name | 2 | 1 | 9 |
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
217 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangxi Lai Bin Hu Lu Wa Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 2 | Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 5 | 4 | 0 |
| 4 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 5 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 6 | Celgene Corporation | 5 | 1 | 0 |
| 7 | Karuna Therapeutics Inc. | 5 | 1 | 0 |
| 8 | Guangdong He Xiang Biopharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Eli Lilly Nederland B.V. | 4 | 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
117 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/08Import · Class 1 | ALXN2420注射液 · No verified English nameJXHL2500162 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/07/08Generic · Class 3 | Bilastine Oral SolutionCYHS2502424 | Jiangsu Zhang Tai Pharma Co., Ltd. romanized |
| 2025/07/08Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2502423 | Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized |
| 2025/07/08Generic · Class 3 | Fudosteine oral solutionCYHS2502419 | Hainan Quan Xing Pharmaceutical Co., Ltd. romanized |
| 2025/07/08Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2502416 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
| 2025/07/08Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2502410 | Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2025/07/08Generic · Class 3 | Calcium Gluconate InjectionCYHS2502405 | Henan Pu Rui Pharma Co., Ltd. romanized |
| 2025/07/08Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2502403 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2025/07/08New drug · Class 1.1 | ZY-A002 · No verified English nameCXZL2500046 | Ya Bao Pharma Group Co., Ltd. romanized |
| 2025/07/08New drug · Class 2.3 | 淫羊藿素软胶囊 · No verified English nameCXZL2500045 | Name not romanized |
| 2025/07/08New drug · Class 1 | 乐德奇拜单抗注射液 · No verified English nameCXSS2500074 | Xian Sheng Pharma Co., Ltd. romanized; Yan Tai Mai Bai Rui International Biopharmaceuticals Co., Ltd. romanized |
| 2025/07/08New drug · Class 1 | 乐德奇拜单抗注射液 · No verified English nameCXSS2500073 | Xian Sheng Pharma Co., Ltd. romanized; Yan Tai Mai Bai Rui International Biopharmaceuticals Co., Ltd. romanized |
| 2025/07/08New drug · Class 2.2 | 注射用维迪西妥单抗 · No verified English nameCXSS2500072 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2025/07/08New drug · Class 1 | 注射用ZGGS34 · No verified English nameCXSL2500561 | Name not romanized; Name not romanized |
| 2025/07/08New drug · Class 3.4 | 人纤维蛋白原 · No verified English nameCXSL2500557 | Guo Yao Group Kunming Xue Ye Zhi Pin Co., Ltd. romanized |
| 2025/07/08New drug · Class 3.4 | 人纤维蛋白原 · No verified English nameCXSL2500556 | Guo Yao Group Kunming Xue Ye Zhi Pin Co., Ltd. romanized |
| 2025/07/08New drug · Class 3.3 | 仑卡奈单抗注射液 · No verified English nameCXSL2500555 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/07/08New drug · Class 3.3 | 甲型肝炎灭活疫苗(人二倍体细胞) · No verified English nameCXSL2500554 | Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized; Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized |
| 2025/07/08New drug · Class 1 | GR1803注射液 · No verified English nameCXSL2500553 | Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/07/08New drug · Class 1 | 自体自然杀伤细胞注射液 · No verified English nameCXSL2500552 | Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized |
| 2025/07/08New drug · Class 2.4 | 示踪用盐酸米托蒽醌注射液 · No verified English nameCXHS2500073 | Shenzhen Hua Run Jiu Chuang Pharmaceuticals Co., Ltd. romanized; Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/07/08New drug · Class 1 | TT-00420片 · No verified English nameCXHL2500658 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized |
| 2025/07/08New drug · Class 1 | TT-00420片 · No verified English nameCXHL2500657 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized |
| 2025/07/08New drug · Class 1 | TT-00420 片 · No verified English nameCXHL2500656 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized |
| 2025/07/08New drug · Class 1 | HRS-3095片 · No verified English nameCXHL2500655 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/07/08New drug · Class 1 | HRS-3095片 · No verified English nameCXHL2500654 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/07/08New drug · Class 1 | LSCCB-PtNNN注射液 · No verified English nameCXHL2500653 | Jin Bo Pharma (Shenzhen) Co., Ltd. romanized |
| 2025/07/08New drug · Class 2.2 | 盐酸右美托咪定微针贴剂 · No verified English nameCXHL2500652 | Guangzhou Xin Ji Pharma Technology Co., Ltd. romanized |
| 2025/07/08New drug · Class 2.2 | 盐酸右美托咪定微针贴剂 · No verified English nameCXHL2500651 | Guangzhou Xin Ji Pharma Technology Co., Ltd. romanized |
| 2025/07/07New drug · Class 3.3 | QL2106注射液 · No verified English nameCXSL2500545 | Qilu Pharmaceutical Co., Ltd. |
87 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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