YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 490 drug applications between 12 June 2025 and 18 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 134, covering 99 drug names.
2025/06/12 – 2025/06/18
- New acceptances this week
- 490
- Drugs with new generic filings (by drug name, de-duplicated)
- 99
- Accepted this week, now under review
- 73
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
490filings, 134 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 201 |
| Generic | 134 |
| New drug | 75 |
| Import | 59 |
| Unspecified | 10 |
| Import re-registration | 10 |
| Medical device (joint review) | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 300 |
| Therapeutic biologic | 96 |
| TCM | 82 |
| Biologic | 7 |
| Prophylactic biologic | 3 |
| In vitro diagnostic reagent | 1 |
| Unspecified | 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
99 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Injection | 11 | 11 | 53 |
| 2 | 苯磺酸左氨氯地平片 · No verified English name | 4 | 2 | 45 |
| 3 | Escitalopram Oxalate Tablets | 3 | 1 | 6 |
| 4 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 5 | Peramivir Injection | 2 | 2 | 7 |
| 6 | 托吡酯口服溶液 · No verified English name | 2 | 2 | 7 |
| 7 | Acetylcysteine Oral Solution | 2 | 1 | 11 |
| 8 | Lactulose Oral Solution | 2 | 1 | 34 |
| 9 | Carbidopa and Levodopa Sustained-release Tablets | 2 | 1 | 2 |
| 10 | Perindopril tert-Butylamine Tablets | 2 | 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
293 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Merck Sharp & Dohme B.V. | 22 | 1 | 0 |
| 2 | Henan Ying Feng Pharmaceuticals Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Pfizer Inc. | 8 | 3 | 0 |
| 4 | Amgen Inc. | 8 | 2 | 0 |
| 5 | Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 6 | Novo Nordisk A/S | 7 | 2 | 0 |
| 7 | Rui Yang Pharmaceutical Co., Ltd. romanized | 7 | 2 | 0 |
| 8 | Name not romanized | 6 | 4 | 0 |
| 9 | AstraZeneca AB | 6 | 3 | 0 |
| 10 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 5 | 4 |
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
174 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/06/18Import · Class 2.2 | DS-1062a · No verified English nameJXSL2500102 | Daiichi Sankyo Inc. |
| 2025/06/18Import · Class 2.2 | 注射用德曲妥珠单抗 · No verified English nameJXSL2500101 | Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2025/06/18Import · Class 2.2 | 比奇珠单抗注射液 · No verified English nameJXSL2500100 | UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd |
| 2025/06/18Import · Class 2.2 | 比奇珠单抗注射液 · No verified English nameJXSL2500099 | UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd |
| 2025/06/18Import · Class 2.1 | 注射用贝林妥欧单抗(皮下注射) · No verified English nameJXSL2500098 | Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd. |
| 2025/06/18Import · Class 2.1 | 注射用贝林妥欧单抗(皮下注射) · No verified English nameJXSL2500097 | Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.? |
| 2025/06/18Import · Class 1 | PF-07248144片 · No verified English nameJXHL2500149 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2025/06/18Import · Class 1 | PF-07248144片 · No verified English nameJXHL2500148 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2025/06/18Generic · Class 3 | 托吡酯口服溶液 · No verified English nameCYHS2502194 | Guangzhou Han Guang Pharma Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized |
| 2025/06/18Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2502193 | Zhong Run Pharma Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized |
| 2025/06/18Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2502192 | Zhong Run Pharma Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized |
| 2025/06/18Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2502188 | Guangzhou Nan Xin Pharmaceutical Co., Ltd. romanized |
| 2025/06/18Generic · Class 3 | Peramivir InjectionCYHS2502187 | Hainan Hui Pu Sen Pharmaceuticals Bio Technology Co., Ltd. romanized |
| 2025/06/18Generic · Class 3 | 聚乙二醇4000散(儿童型) · No verified English nameCYHS2502186 | Hainan Yun Ding Pharmaceuticals Technology Co., Ltd. romanized; Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized |
| 2025/06/18Generic · Class 3 | Eltrombopag Lamine For Oral SuspensionCYHS2502182 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/06/18Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2502177 | Hefei Ying Tai Pharmaceutical Co., Ltd. romanized |
| 2025/06/18Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2502176 | Hefei Ying Tai Pharmaceutical Co., Ltd. romanized |
| 2025/06/18Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2502175 | Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized |
| 2025/06/18Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2502174 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/06/18Generic · Class 3 | Bilastine Oral SolutionCYHS2502169 | Henan Jun Shan Bio Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2025/06/18New drug · Class 3.3 | 雷珠单抗注射液 · No verified English nameCXSS2500067 | Jie Ke (Tianjin) Biopharmaceuticals Co., Ltd. romanized |
| 2025/06/18New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞) (复合佐剂) · No verified English nameCXSL2500498 | Jiangsu Li Wei Si De Bio Technology Co., Ltd. romanized; Li Wei Si De Bio Technology (Shanghai) Co., Ltd. romanized |
| 2025/06/18New drug · Class 1 | SA102-CAR-T注射液 · No verified English nameCXSL2500497 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/06/18New drug · Class 1 | JLM019注射液 · No verified English nameCXSL2500496 | Jie Ku (Shanghai) Biopharmaceuticals Research Co., Ltd. romanized; Jie Ke (Tianjin) Biopharmaceuticals Co., Ltd. romanized |
| 2025/06/18New drug · Class 1 | KN5501细胞注射液 · No verified English nameCXSL2500488 | Shenzhen En Rui Kai Nuo Bio Technology Co., Ltd. romanized |
| 2025/06/18New drug · Class 1 | F-02-2-Na片 · No verified English nameCXHL2500589 | Guangdong Heng Qin Xin Chuang Yi Biopharmaceuticals Co., Ltd. romanized; Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized; Guangzhou Xin Chuang Yi Biopharmaceuticals Co., Ltd. romanized |
| 2025/06/18New drug · Class 1 | F-02-2-Na片 · No verified English nameCXHL2500588 | Guangdong Heng Qin Xin Chuang Yi Biopharmaceuticals Co., Ltd. romanized; Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized; Guangzhou Xin Chuang Yi Biopharmaceuticals Co., Ltd. romanized |
| 2025/06/18New drug · Class 1 | F-02-2-Na片 · No verified English nameCXHL2500587 | Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized; Guangzhou Xin Chuang Yi Biopharmaceuticals Co., Ltd. romanized; Guangdong Heng Qin Xin Chuang Yi Biopharmaceuticals Co., Ltd. romanized |
| 2025/06/17Import · Class 1 | AMG 133 · No verified English nameJXSL2500096 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/17Import · Class 1 | AMG 133 · No verified English nameJXSL2500095 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
144 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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