YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 367 drug applications between 18 August 2025 and 24 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 65 drug names.
2025/08/18 – 2025/08/24
- New acceptances this week
- 367
- Drugs with new generic filings (by drug name, de-duplicated)
- 65
- Accepted this week, now under review
- 101
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
367filings, 93 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 177 |
| Generic | 93 |
| New drug | 65 |
| Import | 19 |
| Unspecified | 8 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 243 |
| TCM | 63 |
| Therapeutic biologic | 52 |
| Biologic | 6 |
| Prophylactic biologic | 3 |
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
65 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 卡格列净二甲双胍缓释片 · No verified English name | 4 | 1 | 5 |
| 2 | Fexofenadine Hydrochloride Tablets | 4 | 1 | 10 |
| 3 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 4 | Magnesium Sulfate Injection | 3 | 2 | 7 |
| 5 | Mirogabalin Besilate Tablets | 3 | 2 | 61 |
| 6 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) | 3 | 2 | 17 |
| 7 | Memantine Hydrochloride OD Tablets | 3 | 1 | 2 |
| 8 | Letermovir Tablets | 2 | 2 | 7 |
| 9 | Potassium Chloride Injection | 2 | 2 | 10 |
| 10 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
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
233 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 11 | 2 | 0 |
| 2 | NAPP PHARMACEUTICALS LIMITED | 9 | 1 | 0 |
| 3 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 6 | 5 | 5 |
| 4 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 2 | 0 |
| 5 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Changchun Jin Sai Pharma Co., Ltd. romanized | 5 | 4 | 1 |
| 7 | BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED | 5 | 3 | 0 |
| 8 | Janssen-Cilag International NV | 5 | 2 | 0 |
| 9 | AstraZeneca AB | 4 | 3 | 0 |
| 10 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc. | 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
116 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/08/23Import · Class 2.2 | 注射用德曲妥珠单抗 · No verified English nameJXSS2500110 | Daiichi Sankyo Europe GmbH; Simtra Deutschland GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2025/08/23Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500228 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/23Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500227 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/23Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500226 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/23Generic · Class 3 | Memantine Hydrochloride OD TabletsCYHS2503099 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/08/23Generic · Class 3 | Memantine Hydrochloride OD TabletsCYHS2503098 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/08/23Generic · Class 3 | Memantine Hydrochloride OD TabletsCYHS2503097 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/08/23Generic · Class 3 | 利伐沙班口崩片 · No verified English nameCYHS2503096 | Hefei En Rui Te Pharma Co., Ltd. romanized |
| 2025/08/23Generic · Class 3 | 利伐沙班口崩片 · No verified English nameCYHS2503095 | Hefei En Rui Te Pharma Co., Ltd. romanized |
| 2025/08/23Generic · Class 3 | 复方氨基酸注射液(18AA-X) · No verified English nameCYHS2503093 | Yuan Da Yi Xue Ying Yang Ke Xue (Wuhan) Co., Ltd. romanized |
| 2025/08/23Generic · Class 3 | Magnesium Sulfate InjectionCYHS2503089 | Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized |
| 2025/08/23Generic · Class 3 | Potassium Chloride InjectionCYHS2503088 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/08/23Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2503087 | Xizang An Xing Pharmaceuticals Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2025/08/23Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2503086 | Xizang An Xing Pharmaceuticals Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2025/08/23New drug · Class 1.1 | 卿芷软膏 · No verified English nameCXZL2500067 | Guangzhou Bo Ji Xin Yao Lin Chuang Research Center Co., Ltd. romanized |
| 2025/08/23New drug · Class 2.2 | 贝莫苏拜单抗注射液 · No verified English nameCXSS2500085 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/08/23New drug · Class 1 | LBM801 · No verified English nameCXSL2500734 | Shanghai Bo Sai Mei Bio Technology Co., Ltd. romanized; Shanghai Li Kang Rui Bio Gong Cheng Co., Ltd. romanized |
| 2025/08/23New drug · Class 1 | SR604注射液 · No verified English nameCXSL2500733 | Shanghai Lai Shi Xue Ye Zhi Pin Co., Ltd. romanized |
| 2025/08/23New drug · Class 1.1 | 冻干结核病mRNA疫苗 · No verified English nameCXSL2500732 | Rui Ji (Beijing) Bio Technology Co., Ltd. romanized; Shenzhen Rui Ji Bio Technology Co., Ltd. romanized; Wuhan Rui Ji Bio Technology Co., Ltd. romanized |
| 2025/08/23New drug · Class 1 | GenSci134注射液 · No verified English nameCXSL2500731 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2025/08/23New drug · Class 1 | GenSci134注射液 · No verified English nameCXSL2500730 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2025/08/23New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHS2500102 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/08/23New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHS2500101 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/08/23New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHS2500100 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/08/23New drug · Class 1 | RNK08954片 · No verified English nameCXHL2500886 | Name not romanized |
| 2025/08/23New drug · Class 1 | RNK08954片 · No verified English nameCXHL2500885 | Name not romanized |
| 2025/08/23New drug · Class 1 | IN10018片 · No verified English nameCXHL2500884 | Ying Shi Bio Technology (Shenzhen) Co., Ltd. romanized |
| 2025/08/23New drug · Class 1 | IN10018片 · No verified English nameCXHL2500883 | Ying Shi Bio Technology (Shenzhen) Co., Ltd. romanized |
| 2025/08/23New drug · Class 1 | YKYY013注射液 · No verified English nameCXHL2500882 | Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized |
| 2025/08/22Import · Class 2.4 | 尼拉帕利阿比特龙片 · No verified English nameJXHS2500089 | Janssen-Cilag International NV; Patheon France; Xian Janssen Pharmaceutical Ltd. |
86 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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