YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 320 drug applications between 29 June 2025 and 5 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 49 drug names.
2025/06/29 – 2025/07/05
- New acceptances this week
- 320
- Drugs with new generic filings (by drug name, de-duplicated)
- 49
- Accepted this week, now under review
- 51
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
320filings, 74 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 168 |
| Generic | 74 |
| New drug | 56 |
| Import | 15 |
| Import re-registration | 5 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 202 |
| TCM | 64 |
| Therapeutic biologic | 52 |
| Prophylactic biologic | 2 |
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
49 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Injection | 6 | 6 | 53 |
| 2 | Oseltamivir Phosphate Capsules | 5 | 2 | 39 |
| 3 | 瑞维那新吸入溶液 · No verified English name | 3 | 3 | 53 |
| 4 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 3 | 2 | 23 |
| 5 | Cefazolin Sodium for Injection | 3 | 1 | 13 |
| 6 | Acyclovir Tablets | 3 | 1 | 6 |
| 7 | 蒙脱石混悬液 · No verified English name | 2 | 2 | 31 |
| 8 | 蔗糖羟基氧化铁咀嚼片 · No verified English name | 2 | 2 | 0 |
| 9 | 帕拉米韦氯化钠注射液 · No verified English name | 2 | 1 | 17 |
| 10 | Tranexamic Acid Tablets | 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
200 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 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 6 | 5 | 0 |
| 3 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 5 | 3 | 0 |
| 4 | Celgene Corporation | 5 | 1 | 0 |
| 5 | Karuna Therapeutics Inc. | 5 | 1 | 0 |
| 6 | Guangdong He Xiang Biopharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Shen Wei Pharma Group 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
97 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/05Import · Class 1 | 乙磺酸LY4066434片 · No verified English nameJXHL2500161 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/07/05Import · Class 1 | 乙磺酸LY4066434片 · No verified English nameJXHL2500160 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/07/05Import · Class 1 | 乙磺酸LY4066434片 · No verified English nameJXHL2500159 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/07/05Generic · Class 3 | Acyclovir TabletsCYHS2502385 | Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2025/07/05Generic · Class 3 | Acyclovir TabletsCYHS2502384 | Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2025/07/05Generic · Class 3 | Acyclovir TabletsCYHS2502383 | Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2025/07/05Generic · Class 3 | Pregabalin Oral SolutionCYHS2502378 | Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized |
| 2025/07/05New drug · Class 1.1 | 参榆消银软膏 · No verified English nameCXZL2500044 | Beijing Si Li An Pharma Co., Ltd. romanized |
| 2025/07/05New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2500551 | Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized |
| 2025/07/05New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2500550 | Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized |
| 2025/07/05New drug · Class 1 | HEC-151注射液 · No verified English nameCXSL2500549 | Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized; Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2025/07/05New drug · Class 1 | 人脐带CD146间充质干细胞注射液 · No verified English nameCXSL2500548 | Beijing San You Li Kang Xi Bao Technology Co., Ltd. romanized |
| 2025/07/05New drug · Class 1 | 宫血间充质干细胞注射液 · No verified English nameCXSL2500547 | Zhejiang Sheng Chuang Jing Zhun Medical Technology Co., Ltd. romanized |
| 2025/07/05New drug · Class 1 | QH104A细胞注射液 · No verified English nameCXSL2500546 | Beijing Qing Hui Lian Nuo Bio Technology Co., Ltd. romanized |
| 2025/07/05New drug · Class 1 | IPG0521注射液 · No verified English nameCXSL2500544 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/05New drug · Class 1 | GZR101-80注射液 · No verified English nameCXSL2500543 | Gan Li Pharma Shandong Co., Ltd. romanized |
| 2025/07/05New drug · Class 1 | 注射用MCLA-129 · No verified English nameCXSL2500542 | Bei Da Pharma Co., Ltd. romanized |
| 2025/07/05New drug · Class 1 | 人源化抗CD19 CAR-T细胞注射液 · No verified English nameCXSL2500541 | Shenyang Jing Sheng Bio Technology Co., Ltd. romanized |
| 2025/07/05New drug · Class 1 | ZHB110舌下片 · No verified English nameCXSL2500540 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2025/07/05New drug · Class 1 | ZHB110舌下片 · No verified English nameCXSL2500539 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2025/07/05New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHS2500072 | Shenzhen Shi Yu Jian Biopharmaceuticals Co., Ltd. romanized; Shenzhen Shi Xin Yang Wei Kang Technology Co., Ltd. romanized |
| 2025/07/05New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHS2500071 | Shenzhen Shi Yu Jian Biopharmaceuticals Co., Ltd. romanized; Shenzhen Shi Xin Yang Wei Kang Technology Co., Ltd. romanized |
| 2025/07/05New drug · Class 1 | 硫酸酯化聚古罗糖醛酸钠颗粒 · No verified English nameCXHL2500650 | Zhongguo Ke College Shanghai Drug Research Institute romanized; Lv Gu (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/05New drug · Class 1 | SYH2066片 · No verified English nameCXHL2500649 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/07/05New drug · Class 1 | SYH2066片 · No verified English nameCXHL2500648 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/07/05New drug · Class 2.4 | 盐酸恩沙替尼胶囊 · No verified English nameCXHL2500647 | Bei Da Pharma Co., Ltd. romanized |
| 2025/07/05New drug · Class 2.4 | 盐酸恩沙替尼胶囊 · No verified English nameCXHL2500646 | Bei Da Pharma Co., Ltd. romanized |
| 2025/07/04Import · Class 2.3 | 迈之灵片 · No verified English nameJXZL2500002 | Aescuven Pharma Deutschland GmbH & Co.KG; Shenzhen Xingyin Pharmaceutical Co. Ltd. |
| 2025/07/04Import · Class 2.3 | 迈之灵片 · No verified English nameJXZL2500001 | Aescuven Pharma Deutschland GmbH & Co. KG; Shenzhen Xingyin Pharmaceutical Co. Ltd. |
| 2025/07/04Import · Class 1 | Trontinemab注射液 · No verified English nameJXSL2500119 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
67 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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