YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 346 drug applications between 17 May 2025 and 23 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 84, covering 63 drug names.
2025/05/17 – 2025/05/23
- New acceptances this week
- 346
- Drugs with new generic filings (by drug name, de-duplicated)
- 63
- Accepted this week, now under review
- 56
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
346filings, 84 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 172 |
| Generic | 84 |
| New drug | 60 |
| Import | 18 |
| Unspecified | 10 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 214 |
| TCM | 67 |
| Therapeutic biologic | 58 |
| Prophylactic biologic | 6 |
| 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
63 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 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 3 | 维立西呱片 · No verified English name | 3 | 1 | 8 |
| 4 | Adapalene And Benzoyl Peroxide Gel | 3 | 1 | 30 |
| 5 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 6 | Iguratimod Tablets | 2 | 2 | 23 |
| 7 | 丙戊酸钠缓释微片 · No verified English name | 2 | 1 | 0 |
| 8 | 地氯雷他定口服溶液 · No verified English name | 2 | 1 | 26 |
| 9 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 10 | Brivaracetam Tablets | 2 | 1 | 19 |
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
218 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 | 20 | 19 | 0 |
| 2 | AstraZeneca AB | 9 | 4 | 0 |
| 3 | Guangdong Sunho Pharmaceutical Co., Ltd. | 6 | 3 | 0 |
| 4 | Zhong Mei Shanghai Shi Gui Bao Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Changzhou Pharmaceutical Factory Co., Ltd. romanized | 5 | 2 | 5 |
| 6 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | Guo Yao Group De Zhong (Fo Shan) Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 4 | 3 | 2 |
| 10 | Guangxi Wan Tong Pharmaceutical Co., Ltd. romanized | 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
112 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/23Import · Class 1 | GHZ339注射液 · No verified English nameJXSL2500081 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/05/23Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2501864 | Hangzhou He Kang Pharma Co., Ltd. romanized |
| 2025/05/23Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2501863 | Hangzhou He Kang Pharma Co., Ltd. romanized |
| 2025/05/23Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2501862 | Hangzhou He Kang Pharma Co., Ltd. romanized |
| 2025/05/23Generic · Class 3 | Hydrotalcite SuspensionCYHS2501860 | Zhejiang Ling Chuang You Pin Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/05/23Generic · Class 3 | Propafenone Hydrochloride InjectionCYHS2501853 | Hubei Tian Sheng Pharma Co., Ltd. romanized |
| 2025/05/23Generic · Class 3 | Potassium Phosphates InjectionCYHS2501851 | Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Xi Er Kang Tai Pharma Co., Ltd. romanized |
| 2025/05/23New drug · Class 1.1 | 通利肠溶胶囊 · No verified English nameCXZS2500022 | Rong Chang Pharmaceutical (Zi Bo) Co., Ltd. romanized |
| 2025/05/23New drug · Class 3.1 | 完带颗粒 · No verified English nameCXZS2500021 | Sichuan Guang Da Pharmaceutical Co., Ltd. romanized |
| 2025/05/23New drug · Class 1.1 | 固本清肺颗粒 · No verified English nameCXZL2500031 | Shenzhen Shi Zhong Hospital romanized |
| 2025/05/23New drug · Class 1.1 | 紫英颗粒 · No verified English nameCXZL2500030 | Guangdong Fang Sheng Rong Ke Pharma Co., Ltd. romanized |
| 2025/05/23New drug · Class 3.3 | 注射用SIM0692 · No verified English nameCXSL2500417 | Shandong Xian Sheng Biopharmaceutical Co., Ltd. romanized |
| 2025/05/23New drug · Class 1 | SHR-7782注射液 · No verified English nameCXSL2500416 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/05/23New drug · Class 1 | SNUG01 · No verified English nameCXSL2500415 | Shen Ji Chang Hua (Beijing) Bio Technology Co., Ltd. romanized |
| 2025/05/23New drug · Class 1 | 斯乐韦米单抗注射液 · No verified English nameCXSL2500414 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/05/23New drug · Class 2.2 | 盐酸奥洛他定口服溶液 · No verified English nameCXHL2500504 | Hainan Wan Wei Pharmaceutical Co., Ltd. romanized |
| 2025/05/23New drug · Class 1 | BGB-45035片 · No verified English nameCXHL2500503 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 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 |
82 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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