YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 389 drug applications between 11 July 2025 and 17 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 118, covering 82 drug names.
2025/07/11 – 2025/07/17
- New acceptances this week
- 389
- Drugs with new generic filings (by drug name, de-duplicated)
- 82
- Accepted this week, now under review
- 77
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
389filings, 118 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 150 |
| Generic | 118 |
| New drug | 84 |
| Import | 22 |
| Import re-registration | 12 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 267 |
| TCM | 67 |
| Therapeutic biologic | 48 |
| 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
82 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 | Minoxidil Liniment | 4 | 2 | 52 |
| 3 | Guanfacine Hydrochloride Extended Release Tablets | 4 | 1 | 4 |
| 4 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 3 | 1 | 12 |
| 5 | Acetylcysteine Injection | 2 | 2 | 53 |
| 6 | 双氯芬酸钠盐酸利多卡因注射液 · No verified English name | 2 | 2 | 8 |
| 7 | 噻托溴铵吸入喷雾剂 · No verified English name | 2 | 2 | 1 |
| 8 | Baricitinib Tablets | 2 | 2 | 32 |
| 9 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 10 | Nicardipine Hydrochloride Injection | 2 | 2 | 13 |
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
245 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan Qing Shan Li Kang Pharma Co., Ltd. romanized | 12 | 6 | 12 |
| 2 | Jiangxi Qing Feng Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 4 | AstraZeneca AB | 5 | 2 | 0 |
| 5 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 4 | 3 | 2 |
| 7 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Hunan Jiudian Pharmaceutical Co., Ltd | 4 | 2 | 0 |
| 10 | F. Hoffmann-La Roche Ltd | 4 | 1 | 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
154 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/17Import · Class 3.1 | 注射用德曲妥珠单抗 · No verified English nameJXSS2500101 | Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2025/07/17Import · Class 3.1 | 加达西单抗注射液 · No verified English nameJXSS2500100 | CSL Behring AG; CSL Behring GmbH; PAREXEL CHINA CO. LTD |
| 2025/07/17Import · Class 2.2 | 罗培干扰素α-2b注射液 · No verified English nameJXSS2500099 | PharmaEssentia Corporation; PharmaEssentia Corporation Taichung Plant; PharmaEssentia Biotechnology (Beijing) Company limited |
| 2025/07/17Import · Class 1 | Leflutrozole胶囊 · No verified English nameJXHL2500186 | ReproNovo SA; Pharmaron (Chengdu) Clinical Services Co. Ltd. |
| 2025/07/17Import · Class 1 | Leflutrozole胶囊 · No verified English nameJXHL2500185 | ReproNovo SA; Pharmaron (Chengdu) Clinical Services Co. Ltd. |
| 2025/07/17Import · Class 1 | Leflutrozole胶囊 · No verified English nameJXHL2500184 | ReproNovo SA; Pharmaron (Chengdu) Clinical Services Co. Ltd. |
| 2025/07/17Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2502573 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/07/17Generic · Class 3 | Sucralfate Oral SuspensionCYHS2502571 | Qingdao Shuang Jing Pharma Co., Ltd. romanized |
| 2025/07/17Generic · Class 3 | 维生素B12注射液 · No verified English nameCYHS2502568 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized |
| 2025/07/17Generic · Class 3 | Bifonazole SolutionCYHS2502567 | Jiangsu He Chen Pharma Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd. |
| 2025/07/17Generic · Class 3 | Colistimethate Sodium for InjectionCYHL2500129 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/07/17Generic · Class 3 | 卡左双多巴肠凝胶 · No verified English nameCYHL2500128 | Hunan Pai Ge Lan Pharma Co., Ltd. romanized |
| 2025/07/17New drug · Class 1 | 注射用YLSH003 · No verified English nameCXSL2500600 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2025/07/17New drug · Class 1 | EMB-07注射液 · No verified English nameCXSL2500599 | Shanghai An Mai Bio Technology Co., Ltd. romanized |
| 2025/07/17New drug · Class 2.2 | SQ-129玻璃体缓释注射液 · No verified English nameCXHL2500712 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2025/07/17New drug · Class 2.2 | SQ-129玻璃体缓释注射液 · No verified English nameCXHL2500711 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2025/07/17New drug · Class 1 | SYH2070注射液 · No verified English nameCXHL2500709 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.; Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2025/07/17New drug · Class 2.2 | LPD-003原位凝胶 · No verified English nameCXHL2500708 | Zhejiang Zi Teng Pharma Technology Co., Ltd. romanized |
| 2025/07/17New drug · Class 1 | GTA182片 · No verified English nameCXHL2500707 | Shanghai Pai Long Bio Technology Co., Ltd. romanized |
| 2025/07/17New drug · Class 1 | GTA182片 · No verified English nameCXHL2500706 | Shanghai Pai Long Bio Technology Co., Ltd. romanized |
| 2025/07/17New drug · Class 1 | D-2570片 · No verified English nameCXHL2500705 | Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized |
| 2025/07/17New drug · Class 1 | PH027-1片 · No verified English nameCXHL2500704 | Suzhou Pu He Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/17New drug · Class 1 | PH027-1片 · No verified English nameCXHL2500703 | Suzhou Pu He Pharmaceuticals Technology Co., Ltd. romanized |
| 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 |
124 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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