YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 390 drug applications between 10 July 2025 and 16 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 107, covering 71 drug names.
2025/07/10 – 2025/07/16
- New acceptances this week
- 390
- Drugs with new generic filings (by drug name, de-duplicated)
- 71
- Accepted this week, now under review
- 70
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
390filings, 107 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 165 |
| Generic | 107 |
| New drug | 82 |
| Import | 22 |
| Import re-registration | 13 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 258 |
| TCM | 76 |
| Therapeutic biologic | 52 |
| Prophylactic biologic | 3 |
| 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
71 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 4 | 2 | 22 |
| 2 | Empagliflozin Tablets | 4 | 2 | 18 |
| 3 | Minoxidil Liniment | 4 | 2 | 52 |
| 4 | Guanfacine Hydrochloride Extended Release Tablets | 4 | 1 | 4 |
| 5 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 3 | 1 | 12 |
| 6 | Acetylcysteine Injection | 2 | 2 | 53 |
| 7 | Baricitinib Tablets | 2 | 2 | 32 |
| 8 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 9 | Nicardipine Hydrochloride Injection | 2 | 2 | 13 |
| 10 | 维生素K1滴剂 · No verified English name | 2 | 2 | 3 |
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
229 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized | 12 | 9 | 0 |
| 2 | Sichuan Qing Shan Li Kang Pharma Co., Ltd. romanized | 12 | 6 | 12 |
| 3 | Jiangxi Qing Feng Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | AstraZeneca AB | 6 | 3 | 0 |
| 5 | Janssen-Cilag International NV | 6 | 3 | 0 |
| 6 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 7 | Eli Lilly and Company | 6 | 1 | 0 |
| 8 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 4 | 3 | 2 |
| 10 | Shandong Sheng Di Pharmaceuticals 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
151 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/16Import · Class 3.1 | 注射用塔拉妥单抗 · No verified English nameJXSS2500103 | Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd. |
| 2025/07/16Import · Class 3.1 | 注射用塔拉妥单抗 · No verified English nameJXSS2500102 | Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd. |
| 2025/07/16Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2502556 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/07/16Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2502555 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/07/16Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2502554 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/07/16Generic · Class 3 | 呋喃妥因胶囊 · No verified English nameCYHS2502553 | Shijiazhuang Rong Wu Di Pharmaceuticals Technology Co., Ltd. romanized; Zi Bo Wan Jie Pharmaceutical Co., Ltd. romanized |
| 2025/07/16Generic · Class 3 | 呋喃妥因胶囊 · No verified English nameCYHS2502552 | Shijiazhuang Rong Wu Di Pharmaceuticals Technology Co., Ltd. romanized; Zi Bo Wan Jie Pharmaceutical Co., Ltd. romanized |
| 2025/07/16Generic · Class 3 | 多种微量元素注射液(4-Ⅱ) · No verified English nameCYHS2502551 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/07/16Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502550 | Qingdao Rui Nai Medical Technology Co., Ltd. romanized |
| 2025/07/16Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2502549 | Qingdao Rui Nai Medical Technology Co., Ltd. romanized |
| 2025/07/16Generic · Class 3 | Furosemide Oral SolutionCYHS2502546 | Zhengzhou Da Ruo Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2025/07/16Generic · Class 3 | Cimetidine InjectionCYHS2502539 | Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2025/07/16Generic · Class 3 | 维生素K1滴剂 · No verified English nameCYHS2502535 | Zhejiang Wei Kang Pharma Co., Ltd. romanized |
| 2025/07/16Generic · Class 3 | 维生素K1滴剂 · No verified English nameCYHS2502534 | Kui Hua Pharma Group (Xiang Yang) Long Zhong Co., Ltd. romanized |
| 2025/07/16New drug · Class 3.1 | 宣郁通经汤颗粒 · No verified English nameCXZS2500030 | Hefei Hua Run Shen Lu Pharma Co., Ltd. romanized |
| 2025/07/16New drug · Class 1 | HS_SW01细胞注射液 · No verified English nameCXSL2500598 | Shenzhen Hui Shan Bio Technology Co., Ltd. romanized |
| 2025/07/16New drug · Class 1 | HS_SW01细胞注射液 · No verified English nameCXSL2500597 | Shenzhen Hui Shan Bio Technology Co., Ltd. romanized |
| 2025/07/16New drug · Class 1 | TJ101注射液 · No verified English nameCXSL2500596 | Tian Jing Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2025/07/16New drug · Class 1 | HX044注射液 · No verified English nameCXSL2500595 | Han Si Ai Tai Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized |
| 2025/07/16New drug · Class 2.2 | ACYW135群脑膜炎球菌结合疫苗 · No verified English nameCXSL2500594 | Shanghai Rui Zhou Bio Technology Co., Ltd. romanized; Shanghai Wei Zhou Bio Technology Co., Ltd. romanized; Changchun Rui Zhou Biopharmaceutical Co., Ltd. romanized |
| 2025/07/16New drug · Class 2.2 | 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2500083 | Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/07/16New drug · Class 2.2 | 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2500082 | Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/07/16New drug · Class 2.2 | 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2500081 | Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/07/16New drug · Class 2.2 | 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2500080 | Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/07/16New drug · Class 1 | IBI3032 · No verified English nameCXHL2500702 | Xin Da Bio Technology Co., Ltd. romanized |
| 2025/07/16New drug · Class 1 | IBI3032 · No verified English nameCXHL2500701 | Xin Da Bio Technology Co., Ltd. romanized |
| 2025/07/16New drug · Class 1 | IBI3032 · No verified English nameCXHL2500700 | Xin Da Bio Technology Co., Ltd. romanized |
| 2025/07/16New drug · Class 1 | IBI3032 · No verified English nameCXHL2500699 | Xin Da Bio Technology Co., Ltd. romanized |
| 2025/07/15Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2502531 | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized |
| 2025/07/15Generic · Class 3 | Dexamethasone Sodium Phosphate InjectionCYHS2502529 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
121 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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