YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 440 drug applications between 9 June 2025 and 15 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 122, covering 80 drug names.
2025/06/09 – 2025/06/15
- New acceptances this week
- 440
- Drugs with new generic filings (by drug name, de-duplicated)
- 80
- Accepted this week, now under review
- 65
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
440filings, 122 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 184 |
| Generic | 122 |
| New drug | 70 |
| Import | 43 |
| Unspecified | 11 |
| Import re-registration | 9 |
| Medical device (joint review) | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 286 |
| Therapeutic biologic | 73 |
| TCM | 69 |
| Biologic | 7 |
| Prophylactic biologic | 3 |
| In vitro diagnostic reagent | 1 |
| Unspecified | 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
80 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Injection | 18 | 17 | 53 |
| 2 | Brexpiprazole Tablets | 4 | 2 | 31 |
| 3 | 苯磺酸左氨氯地平片 · No verified English name | 4 | 2 | 45 |
| 4 | Carbidopa and Levodopa Sustained-release Tablets | 3 | 2 | 2 |
| 5 | Sacubitril Valsartan Sodium Tablets | 3 | 2 | 70 |
| 6 | 中性低钙腹膜透析液(碳酸氢盐-G4.25%) · No verified English name | 2 | 2 | 1 |
| 7 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 8 | Ethyl Iosapentate Capsules | 2 | 2 | 27 |
| 9 | Acetylcysteine Oral Solution | 2 | 1 | 11 |
| 10 | Lactulose Oral Solution | 2 | 1 | 34 |
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
271 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Merck Sharp & Dohme B.V. | 22 | 1 | 0 |
| 2 | Henan Ying Feng Pharmaceuticals Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Rui Yang Pharmaceutical Co., Ltd. romanized | 7 | 2 | 0 |
| 5 | Qilu Pharmaceutical Co., Ltd. | 5 | 4 | 1 |
| 6 | Name not romanized | 5 | 3 | 0 |
| 7 | AstraZeneca AB | 5 | 2 | 0 |
| 8 | Pfizer Inc. | 5 | 2 | 0 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized | 5 | 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
145 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/06/14Import · Class 1 | 注射用MK-2400 · No verified English nameJXSL2500089 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2025/06/14Import · Class 1 | 注射用MK-5909 · No verified English nameJXSL2500088 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2025/06/14Import · Class 2.4 | 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHL2500144 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd |
| 2025/06/14Import · Class 2.4 | 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHL2500143 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd |
| 2025/06/14Import · Class 1 | AZD6793 · No verified English nameJXHL2500142 | AstraZeneca AB |
| 2025/06/14Import · Class 1 | AZD6793 · No verified English nameJXHL2500141 | AstraZeneca AB |
| 2025/06/14Import · Class 1 | AZD6793 · No verified English nameJXHL2500140 | AstraZeneca AB |
| 2025/06/14Generic · Class 3 | Ketorolac Trometamol TabletsCYHS2502133 | Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized |
| 2025/06/14Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2502131 | Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized |
| 2025/06/14Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2502130 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized |
| 2025/06/14Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2502129 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized |
| 2025/06/14Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2502125 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/06/14Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2502123 | Jiangsu Cheng Kang Pharma Co., Ltd. romanized |
| 2025/06/14Generic · Class 3 | 醋酸锌颗粒 · No verified English nameCYHS2502120 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2025/06/14Generic · Class 3 | 醋酸锌颗粒 · No verified English nameCYHS2502119 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2025/06/14Generic · Class 3 | 贝美前列素涂剂 · No verified English nameCYHL2500113 | Zhejiang Fu Nuo Pharmaceuticals Co., Ltd. romanized |
| 2025/06/14New drug · Class 1 | IBI343 · No verified English nameCXSL2500487 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/06/14New drug · Class 1 | 注射用ZG005 · No verified English nameCXSL2500486 | Name not romanized; Name not romanized |
| 2025/06/14New drug · Class 1 | 洛奈利单抗注射液 · No verified English nameCXSL2500485 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2025/06/14New drug · Class 2.2 | 兰索拉唑碳酸氢钠干混悬剂 · No verified English nameCXHS2500067 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/06/14New drug · Class 1 | HP-001胶囊 · No verified English nameCXHL2500580 | Shanghai Chao Yang Pharma Co., Ltd. romanized |
| 2025/06/14New drug · Class 1 | HP-001胶囊 · No verified English nameCXHL2500579 | Shanghai Chao Yang Pharma Co., Ltd. romanized |
| 2025/06/14New drug · Class 1 | HP-001胶囊 · No verified English nameCXHL2500578 | Shanghai Chao Yang Pharma Co., Ltd. romanized |
| 2025/06/14New drug · Class 2.4 | 盐酸吉卡昔替尼片 · No verified English nameCXHL2500577 | Name not romanized; Name not romanized |
| 2025/06/14New drug · Class 1 | 注射用FZ-P001钠 · No verified English nameCXHL2500576 | Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized |
| 2025/06/14New drug · Class 2.2 | JSS-222 · No verified English nameCXHL2500575 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/06/14New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2500574 | Fujian Ji Nuo Hou Pu Bio Technology Co., Ltd. romanized |
| 2025/06/14New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2500573 | Fujian Ji Nuo Hou Pu Bio Technology Co., Ltd. romanized |
| 2025/06/14New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2500572 | Fujian Ji Nuo Hou Pu Bio Technology Co., Ltd. romanized |
| 2025/06/14New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2500571 | Fujian Ji Nuo Hou Pu Bio Technology Co., Ltd. romanized |
115 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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