YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 349 drug applications between 15 January 2025 and 21 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 108, covering 76 drug names.
2025/01/15 – 2025/01/21
- New acceptances this week
- 349
- Drugs with new generic filings (by drug name, de-duplicated)
- 76
- Accepted this week, now under review
- 8
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
349filings, 108 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 108 |
| New drug | 56 |
| Import | 26 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 261 |
| TCM | 49 |
| Therapeutic biologic | 35 |
| Prophylactic biologic | 4 |
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
76 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ruxolitinib Phosphate Tablets | 6 | 2 | 27 |
| 2 | 帕拉米韦氯化钠注射液 · No verified English name | 4 | 2 | 17 |
| 3 | Mivacurium Chloride Injection | 4 | 2 | 3 |
| 4 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 5 | Ethyl Iosapentate Capsules | 2 | 2 | 27 |
| 6 | Pentoxifylline Modified Release Tablets | 2 | 2 | 6 |
| 7 | Isavuconazonium Sulfate for Injection | 2 | 2 | 15 |
| 8 | Tedizolid Phosphate For Injection | 2 | 2 | 3 |
| 9 | 聚乙二醇钠钾散 · No verified English name | 2 | 2 | 3 |
| 10 | Benzbromarone Tablets | 2 | 2 | 4 |
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
214 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 16 | 12 | 0 |
| 2 | Xiu Zheng Pharma Group Lin Yi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 12 | 12 | 0 |
| 3 | Anhui Shuang He Pharma Co., Ltd. romanized | 8 | 2 | 0 |
| 4 | AstraZeneca AB | 6 | 5 | 0 |
| 5 | Yunnan Yi Zhi Hao Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 6 | Fresenius Kabi AB | 5 | 1 | 0 |
| 7 | Shandong Qidu Pharmaceutical Co., Ltd. | 4 | 3 | 1 |
| 8 | Alexion Pharmaceuticals Inc. | 4 | 2 | 0 |
| 9 | Chengdu Rong Sheng Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Hainan Brilliant Pharmaceutical Co., Ltd. | 4 | 2 | 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
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/21Import · Class 1 | AZD5492 · No verified English nameJXSL2500016 | AstraZeneca AB; AstraZeneca Global ll&U (China) Co. Ltd. |
| 2025/01/21Import · Class 1 | AZD5492 · No verified English nameJXSL2500015 | AstraZeneca AB; AstraZeneca Global ll&U (China) Co. Ltd. |
| 2025/01/21Import · Class 1 | AZD2936 · No verified English nameJXSL2500014 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/01/21Import · Class 2.2 | Ravulizumab注射液 · No verified English nameJXSL2500013 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/01/21Import · Class 2.2 | Ravulizumab注射液 · No verified English nameJXSL2500012 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/01/21Import · Class 1 | Bexicaserin口服溶液 · No verified English nameJXHL2500013 | Longboard Pharmaceuticals Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2025/01/21Generic · Class 3 | Ketotifen Fumarate Oral SolutionCYHS2500385 | Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized |
| 2025/01/21Generic · Class 3 | Sildenafil Sitrate For Oral SuspensionCYHS2500378 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/01/21Generic · Class 3 | Pioglitazone and Metformin Hydrochloride TabletsCYHS2500376 | Yan Tai Zheng Fang Pharmaceutical Co., Ltd. romanized |
| 2025/01/21Generic · Class 3 | Azilsartan and Amlodipine TabletsCYHS2500375 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/01/21Generic · Class 3 | Epalrestat TabletsCYHS2500372 | Shenyang Yong Da Pharmaceutical Co., Ltd. romanized |
| 2025/01/21Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2500371 | Chengdu Yi Lu Rong Yao Drug Technology Co., Ltd. romanized |
| 2025/01/21Generic · Class 3 | Potassium Phosphates InjectionCYHS2500370 | Chi Feng Yuan Sheng Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2025/01/21Generic · Class 3 | 微量元素注射液4-II · No verified English nameCYHS2500368 | Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/01/21Generic · Class 3 | Buspirone Hydrochloride TabletsCYHS2500367 | Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2025/01/21Generic · Class 3 | Progesterone InjectionCYHS2500365 | Shanghai Hui Yong Pharmaceutical Co., Ltd. romanized |
| 2025/01/21Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2500364 | Bai Shi Dun (Hainan) Medical Technology Co., Ltd. romanized; Dong Guan Shi Jin Mei Ji Pharma Co., Ltd. romanized |
| 2025/01/21Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2500363 | Chi Feng Yuan Sheng Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2025/01/21New drug · Class 3.4 | 注射用重组人脑利钠肽 · No verified English nameCXSS2500006 | Suzhou Lan Ding Biopharmaceutical Co., Ltd. romanized |
| 2025/01/21New drug · Class 2.2 | 20价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2500061 | Yunnan Wo Sen Bio Technology Co., Ltd. romanized; Yu Xi Wo Sen Bio Technology Co., Ltd. romanized; Yunnan Yi Miao Laboratory Co., Ltd. romanized |
| 2025/01/21New drug · Class 1 | BBM-D101注射液 · No verified English nameCXSL2500060 | Xin Zhong Pharmaceuticals Technology (Beijing) Co., Ltd. romanized; Shanghai Mian Yi Bio Technology Co., Ltd. romanized; Shanghai Xin Zhi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/21New drug · Class 2.4 | DJ-01注射剂 · No verified English nameCXSL2500059 | Suzhou De Jin Biopharmaceutical Co., Ltd. romanized |
| 2025/01/21New drug · Class 1.2 | YKYY026注射液 · No verified English nameCXSL2500058 | Hangzhou Tian Long Pharma Co., Ltd. romanized |
| 2025/01/21New drug · Class 1 | 注射用7MW3711 · No verified English nameCXSL2500057 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2025/01/21New drug · Class 3.3 | 罗莫佐单抗注射液 · No verified English nameCXSL2500056 | Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized |
| 2025/01/21New drug · Class 1 | XS228细胞注射液 · No verified English nameCXSL2500055 | Shi Ze Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2025/01/21New drug · Class 2.2 | LJ01003 · No verified English nameCXHS2500009 | Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized |
| 2025/01/21New drug · Class 2.2 | LJ01003 · No verified English nameCXHS2500008 | Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized |
| 2025/01/21New drug · Class 1 | 硫酸心舒帕莎片 · No verified English nameCXHL2500102 | Shandong Qidu Pharmaceutical Co., Ltd.; Shandong University romanized; Shandong University Qi Lu Hospital romanized |
| 2025/01/21New drug · Class 1 | 硫酸心舒帕莎片 · No verified English nameCXHL2500101 | Shandong Qidu Pharmaceutical Co., Ltd.; Shandong University romanized; Shandong University Qi Lu Hospital romanized |
84 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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