YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 289 drug applications between 29 March 2025 and 4 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 57 drug names.
2025/03/29 – 2025/04/04
- New acceptances this week
- 289
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- Accepted this week, now under review
- 22
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
289filings, 79 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 157 |
| Generic | 79 |
| New drug | 33 |
| Import | 11 |
| Unspecified | 4 |
| Import re-registration | 4 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 152 |
| TCM | 87 |
| Therapeutic biologic | 49 |
| Prophylactic 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
57 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 维生素B6注射液 · No verified English name | 3 | 3 | 10 |
| 2 | Tadalafil Tablets | 3 | 1 | 23 |
| 3 | Polidocanol Injection | 3 | 1 | 23 |
| 4 | 低钙腹膜透析液(乳酸盐-G1.5%) · No verified English name | 2 | 1 | 3 |
| 5 | 低钙腹膜透析液(乳酸盐-G2.5%) · No verified English name | 2 | 1 | 4 |
| 6 | 低钙腹膜透析液(乳酸盐-G4.25%) · No verified English name | 2 | 1 | 3 |
| 7 | Dexketoprofen Trometamol Tablets | 2 | 1 | 0 |
| 8 | Tropicamide Phenylephrine Eye Drops | 2 | 1 | 8 |
| 9 | Fusidic Acid Cream | 2 | 1 | 15 |
| 10 | Famciclovir Tablets | 2 | 1 | 0 |
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
159 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 15 | 10 | 0 |
| 2 | Shaanxi Pan Long Pharma Group Co., Ltd. romanized | 13 | 11 | 0 |
| 3 | Ningbo Tian Yi Pharma Technology Co., Ltd. romanized | 12 | 6 | 12 |
| 4 | Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized | 8 | 6 | 0 |
| 5 | Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 6 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Jin He Zang Yao Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized | 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
68 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/04/03Import · Class 3.1 | 注射用德曲妥珠单抗 · No verified English nameJXSS2500041 | Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2025/04/03Import · Class 3.1 | 本瑞利珠单抗注射液 · No verified English nameJXSS2500040 | AstraZeneca AB; Name not romanized |
| 2025/04/03Import · Class 3.1 | 本瑞利珠单抗注射液 · No verified English nameJXSS2500039 | AstraZeneca AB; Name not romanized |
| 2025/04/03Import · Class 2.2 | Ravulizumab注射液 · No verified English nameJXSL2500052 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/04/03Import · Class 2.2 | Ravulizumab注射液 · No verified English nameJXSL2500051 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/04/03Import · Class 1 | Bimagrumab注射液 · No verified English nameJXSL2500050 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/03Import · Class 1 | Bimagrumab注射液 · No verified English nameJXSL2500049 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/03Import · Class 2.2 | 注射用佐妥昔单抗 · No verified English nameJXSL2500048 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2025/04/03Generic · Class 3 | Diprophylline InjectionCYHS2501299 | Shandong Yi Jian Pharma Co., Ltd. romanized |
| 2025/04/03Generic · Class 3 | Acetylcysteine TabletsCYHS2501292 | Hainan Sai Li Ke Pharma Co., Ltd. romanized |
| 2025/04/03Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2501282 | Wuhan Shi Xiao Bo Bio Technology Co., Ltd. romanized; Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized |
| 2025/04/03Generic · Class 3 | Indobufen TabletsCYHS2501281 | Zhengzhou Han Dou Pharma Group Co., Ltd. romanized |
| 2025/04/03Generic · Class 3 | Tolvaptan Orally Disintegrating TabletsCYHS2501277 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2025/04/03Generic · Class 3 | Acetylcysteine InjectionCYHS2501276 | Guangdong Jun Kang Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/04/03Generic · Class 3 | Ketotifen Fumarate Oral SolutionCYHS2501275 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/04/03Generic · Class 3 | Potassium Phosphates InjectionCYHS2501270 | Anhui Shuang He Pharma Co., Ltd. romanized |
| 2025/04/03Generic · Class 3 | Ebastine Oral SolutionCYHS2501258 | Jiangxi Xin Zheng Pharma Co., Ltd. romanized |
| 2025/04/03Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2501257 | Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2025/04/03Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2501255 | Jiangsu Yue Xing Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized |
| 2025/04/03Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2501253 | Hubei Hai Mei Na Pharmaceuticals Technology Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized |
| 2025/04/03Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2501245 | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2025/04/03Generic · Class 3 | Dexketoprofen Trometamol TabletsCYHS2501242 | Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized |
| 2025/04/03Generic · Class 3 | Dexketoprofen Trometamol TabletsCYHS2501241 | Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized |
| 2025/04/03New drug · Class 1.1 | 芪桂络痹通片 · No verified English nameCXZS2500014 | Beijing Yi Ling Pharma Co., Ltd. romanized; Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2025/04/03New drug · Class 3.1 | 二冬汤颗粒 · No verified English nameCXZS2500013 | Zhejiang Wei Kang Pharma Co., Ltd. romanized |
| 2025/04/03New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2500043 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized |
| 2025/04/03New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2500042 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized |
| 2025/04/03New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2500041 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized |
| 2025/04/03New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2500040 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized |
| 2025/04/03New drug · Class 1 | Cizutamig注射液 · No verified English nameCXSL2500265 | Shanghai Tan Di Biopharmaceuticals Technology Co., Ltd. romanized |
38 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.