YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 365 drug applications between 16 May 2025 and 22 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 59 drug names.
2025/05/16 – 2025/05/22
- New acceptances this week
- 365
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- 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
365filings, 78 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 195 |
| Generic | 78 |
| New drug | 61 |
| Import | 17 |
| Unspecified | 12 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 222 |
| TCM | 76 |
| Therapeutic biologic | 58 |
| 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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Potassium Chloride Oral Solution | 4 | 2 | 11 |
| 2 | 维立西呱片 · No verified English name | 3 | 1 | 8 |
| 3 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 4 | Iguratimod Tablets | 2 | 2 | 23 |
| 5 | 丙戊酸钠缓释微片 · No verified English name | 2 | 1 | 0 |
| 6 | 地氯雷他定口服溶液 · No verified English name | 2 | 1 | 26 |
| 7 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 22 |
| 8 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 9 | Brivaracetam Tablets | 2 | 1 | 19 |
| 10 | Methylprednisolone Sodium Succinate for injection | 2 | 1 | 12 |
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 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 17 | 16 | 0 |
| 2 | AstraZeneca AB | 8 | 4 | 0 |
| 3 | Hong Tao Kai Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Changzhou Pharmaceutical Factory Co., Ltd. romanized | 5 | 2 | 5 |
| 5 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized | 5 | 2 | 0 |
| 6 | CISEN PHARMACEUTICAL CO., LTD. | 5 | 2 | 1 |
| 7 | Guo Yao Group De Zhong (Fo Shan) Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Hainan Hai Li Pharmaceutical Co., Ltd. romanized | 4 | 4 | 1 |
| 9 | Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 4 | 3 | 2 |
| 10 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 4 | 2 | 2 |
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
111 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/22Import · Class 1 | Depemokimab注射液 · No verified English nameJXSL2500080 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2025/05/22Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2501850 | Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized |
| 2025/05/22Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2501849 | Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized |
| 2025/05/22Generic · Class 3 | Verapamil Hydrochloride InjectionCYHS2501844 | Anhui Mei Lai Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
| 2025/05/22Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2501842 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/05/22Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2501841 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/05/22Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2501840 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/05/22Generic · Class 3 | 酮洛芬凝胶贴膏 · No verified English nameCYHL2500097 | Hunan Pai Ge Lan Pharma Co., Ltd. romanized |
| 2025/05/22New drug · Class 2.2 | 注射用芦康沙妥珠单抗 · No verified English nameCXSS2500052 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2025/05/22New drug · Class 1 | GR2001注射液 · No verified English nameCXSS2500051 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/05/22New drug · Class 1 | 注射用TJ101 · No verified English nameCXSL2500413 | Yi Xian Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2025/05/22New drug · Class 1 | 宫血间充质干细胞注射液 · No verified English nameCXSL2500412 | Zhejiang Sheng Chuang Jing Zhun Medical Technology Co., Ltd. romanized |
| 2025/05/22New drug · Class 3.3 | 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2500411 | Hua Lan Bio Yi Miao Co., Ltd. romanized |
| 2025/05/22New drug · Class 1 | 苯甲酸安达替尼胶囊 · No verified English nameCXHS2500055 | An Shi Pharma (Ningbo) Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2025/05/22New drug · Class 1 | 苯甲酸安达替尼胶囊 · No verified English nameCXHS2500054 | An Shi Pharma (Ningbo) Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2025/05/22New drug · Class 1 | MDI-1228_mesylate滴鼻液 · No verified English nameCXHL2500502 | Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized |
| 2025/05/22New drug · Class 1 | MDI-1228_mesylate滴鼻液 · No verified English nameCXHL2500501 | Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized |
| 2025/05/22New drug · Class 1 | 注射用DYX116 · No verified English nameCXHL2500500 | Jiangsu Deyuan Pharmaceutical Co.,Ltd. |
| 2025/05/22New drug · Class 1 | 注射用DYX116 · No verified English nameCXHL2500499 | Jiangsu Deyuan Pharmaceutical Co.,Ltd. |
| 2025/05/22New drug · Class 1 | HW241045片 · No verified English nameCXHL2500498 | Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized |
| 2025/05/22New drug · Class 1 | HW241045片 · No verified English nameCXHL2500497 | Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized |
| 2025/05/22New drug · Class 2.3 | TAP-1504凝胶 · No verified English nameCXHL2500496 | Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/21Import · Class 3.1 | 度普利尤单抗注射液 · No verified English nameJXSS2500063 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2025/05/21Import · Class 3.1 | 度普利尤单抗注射液 · No verified English nameJXSS2500062 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2025/05/21Import · Class 1 | 注射用Felzartamab · No verified English nameJXSL2500079 | Biogen Idec Research Limited |
| 2025/05/21Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2501839 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2025/05/21Generic · Class 3 | 美沙拉秦肠溶缓释胶囊 · No verified English nameCYHS2501835 | Gan Li Pharma Shandong Co., Ltd. romanized |
| 2025/05/21Generic · Class 3 | Bilastine Oral SolutionCYHS2501831 | Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/05/21Generic · Class 3 | Colesevelam Hydrochloride TabletsCYHS2501828 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2025/05/21Generic · Class 3 | 丙戊酸钠缓释微片 · No verified English nameCYHL2500095 | Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized |
81 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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