YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 306 drug applications between 24 May 2025 and 30 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 57 drug names.
2025/05/24 – 2025/05/30
- New acceptances this week
- 306
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- Accepted this week, now under review
- 33
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
306filings, 76 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 151 |
| Generic | 76 |
| New drug | 50 |
| Import | 14 |
| Unspecified | 8 |
| Import re-registration | 6 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 196 |
| TCM | 54 |
| Therapeutic biologic | 45 |
| Prophylactic biologic | 7 |
| 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
57 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Injection | 4 | 4 | 53 |
| 2 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 3 | Adapalene And Benzoyl Peroxide Gel | 3 | 2 | 30 |
| 4 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 5 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 6 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
| 7 | 利伐沙班口崩片 · No verified English name | 2 | 1 | 4 |
| 8 | 复方氨基酸注射液(20AA-Ⅱ) · No verified English name | 2 | 1 | 0 |
| 9 | Levothyroxine Sodium Tablets | 2 | 1 | 12 |
| 10 | Levobupivacaine Hydrochloride Injection | 2 | 1 | 2 |
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
193 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shaanxi Pan Long Pharma Group Co., Ltd. romanized | 13 | 11 | 0 |
| 2 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 3 | 0 |
| 3 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Haerbin Tong Yi Tang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | Quan Zhou Zhong Qiao Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Guizhou Sheng Shi Long Fang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | UCB Pharma S.A. | 4 | 1 | 0 |
| 8 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Jilin Sheng Qi Ke Pharma Co., Ltd. romanized | 3 | 3 | 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
82 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/30Import · Class 2.2 | 伊奈利珠单抗注射液 · No verified English nameJXSS2500070 | Horizon Therapeutics Ireland DAC; AstraZeneca Nijmegen B.V.; Changzhou Hansoh Pharmaceutical Co. Ltd. |
| 2025/05/30Import · Class 1 | PF-08046047 · No verified English nameJXSL2500085 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2025/05/30Import · Class 2.1 | Mosunetuzumab Injection (Subcutaneous Injection) · No verified English nameJXSL2500084 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2025/05/30Import · Class 2.1 | Mosunetuzumab Injection (Subcutaneous Injection) · No verified English nameJXSL2500083 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2025/05/30Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2501936 | Shanghai He Feng Pharmaceutical Co., Ltd. romanized |
| 2025/05/30Generic · Class 3 | 复方氨基酸注射液(20AA-Ⅱ) · No verified English nameCYHS2501930 | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized |
| 2025/05/30Generic · Class 3 | 复方氨基酸注射液(20AA-Ⅱ) · No verified English nameCYHS2501929 | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized |
| 2025/05/30Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2501927 | Nanjing Hai Jing Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2025/05/30Generic · Class 3 | Ambroxol Hydrochloride DropsCYHS2501926 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/05/30Generic · Class 3 | Ambroxol Hydrochloride DropsCYHS2501925 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/05/30New drug · Class 3.3 | 雷珠单抗注射液 · No verified English nameCXSS2500055 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2025/05/30New drug · Class 1 | 注射用YL202 · No verified English nameCXSL2500437 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2025/05/30New drug · Class 1 | BGB-16673片 · No verified English nameCXHL2500526 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/05/30New drug · Class 1 | BGB-16673片 · No verified English nameCXHL2500525 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/05/30New drug · Class 1 | SZ2001片 · No verified English nameCXHL2500524 | Su Zhong Pharma Group Co., Ltd. romanized; Jiangsu Su Zhong Pharma Research Institute Co., Ltd. romanized |
| 2025/05/30New drug · Class 1 | SZ2001片 · No verified English nameCXHL2500523 | Su Zhong Pharma Group Co., Ltd. romanized; Jiangsu Su Zhong Pharma Research Institute Co., Ltd. romanized |
| 2025/05/30New drug · Class 1 | HSK47388片 · No verified English nameCXHL2500522 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2025/05/30New drug · Class 1 | HSK47388片 · No verified English nameCXHL2500521 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2025/05/30New drug · Class 2.2 | CZ006注射液 · No verified English nameCXHL2500520 | Zhejiang Cui Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/29Import · Class 1 | Giredestrant · No verified English nameJXHL2500122 | Genentech Inc.; Roche (China) Holding Ltd. |
| 2025/05/29Generic · Class 3 | Ketotifen Fumarate Oral SolutionCYHS2501921 | Anhui Mao Kang Pharma Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2025/05/29Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G4.25%) · No verified English nameCYHS2501913 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/05/29Generic · Class 3 | Deoxycholic Acid InjectionCYHL2500099 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/05/29New drug · Class 1.2 | JMZ-2102胶囊 · No verified English nameCXZL2500034 | Jiangxi Ji Min Ke Xin Pharma Co., Ltd. romanized |
| 2025/05/29New drug · Class 1.2 | JMZ-2102 · No verified English nameCXZL2500033 | Jiangxi Ji Min Ke Xin Pharma Co., Ltd. romanized |
| 2025/05/29New drug · Class 1.1 | 健脾疏肝固本颗粒 · No verified English nameCXZL2500032 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2025/05/29New drug · Class 1 | 注射用YL201 · No verified English nameCXSL2500436 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2025/05/29New drug · Class 1 | IBI363 · No verified English nameCXSL2500435 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/05/29New drug · Class 1 | IBI363 · No verified English nameCXSL2500434 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/05/29New drug · Class 1 | 注射用MHB088C · No verified English nameCXSL2500433 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
52 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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