YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 293 drug applications between 19 June 2025 and 25 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 88, covering 56 drug names.
2025/06/19 – 2025/06/25
- New acceptances this week
- 293
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- Accepted this week, now under review
- 53
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
293filings, 88 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 129 |
| Generic | 88 |
| New drug | 47 |
| Import | 18 |
| Import re-registration | 7 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 177 |
| TCM | 65 |
| Therapeutic biologic | 48 |
| Prophylactic biologic | 2 |
| 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
56 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Injection | 7 | 7 | 53 |
| 2 | Ethyl Iosapentate Capsules | 4 | 3 | 27 |
| 3 | 瑞维那新吸入溶液 · No verified English name | 3 | 3 | 53 |
| 4 | Glucosamine Sulfate Capsules | 3 | 3 | 51 |
| 5 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 6 | 苯磺酸左氨氯地平片 · No verified English name | 3 | 2 | 45 |
| 7 | Febuxostat Tablets | 3 | 2 | 12 |
| 8 | Tadalafil Tablets | 3 | 1 | 23 |
| 9 | 氧 · No verified English name | 2 | 2 | 15 |
| 10 | 注射用甲苯磺酸奥马环素 · No verified English name | 2 | 2 | 9 |
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
209 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Amgen Inc. | 7 | 2 | 0 |
| 2 | Novo Nordisk A/S | 5 | 1 | 0 |
| 3 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 4 |
| 4 | Roche Pharma (Schweiz) AG | 4 | 2 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 6 | Shanghai He Huang Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 7 | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | 3 | 3 | 0 |
| 8 | Hunan Tai Yang Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Tong Hua Ji Tong Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Pfizer Inc. | 3 | 2 | 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
85 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/06/25Import · Class 2.2; 2.4 | 利福布汀注射用浓溶液 · No verified English nameJXHL2500153 | BioVersys AG; GuangZhou BioVersys Pharmaceutical Co. Ltd |
| 2025/06/25Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2502273 | Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2025/06/25Generic · Class 3 | 米拉贝隆缓释干混悬剂 · No verified English nameCYHL2500121 | Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized |
| 2025/06/25New drug · Class 1 | IMS001注射液 · No verified English nameCXSL2500514 | Zhuhai Heng Qin Ai Mu Si Tan Bio Technology Co., Ltd. romanized |
| 2025/06/25New drug · Class 1 | AXT-1003胶囊 · No verified English nameCXHL2500618 | Ai Si Tuo Kang Pharmaceuticals Technology (Beijing) Co., Ltd. romanized |
| 2025/06/24Import · Class 1 | U3-1402 · No verified English nameJXSL2500112 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2025/06/24Import · Class 1 | PF-08046054 (注射用冻干粉针) · No verified English nameJXSL2500111 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2025/06/24Import · Class 1 | ALPN-303注射液 · No verified English nameJXSL2500110 | Vertex Pharmaceuticals Incorporated; Name not romanized |
| 2025/06/24Generic · Class 3 | Ebastine Oral SolutionCYHS2502258 | Ren Xi Pharmaceuticals Technology Hebei Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/06/24Generic · Class 3 | Bilastine Oral SolutionCYHS2502257 | Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/06/24Generic · Class 3 | Sucralfate Oral SuspensionCYHS2502256 | Hefei Guo Gao Pharma Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized |
| 2025/06/24New drug · Class 1 | GR2303注射液 · No verified English nameCXSL2500512 | Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/06/24New drug · Class 1 | TQH2722注射液 · No verified English nameCXSL2500511 | Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2025/06/24New drug · Class 1 | ALMB-0166注射液 · No verified English nameCXSL2500510 | Shanghai En Le Mai Bio Technology Co., Ltd. romanized |
| 2025/06/24New drug · Class 3.2 | 流感病毒裂解疫苗(高剂量) · No verified English nameCXSL2500509 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2025/06/24New drug · Class 1 | TQC2731注射液 · No verified English nameCXSL2500508 | Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2025/06/24New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHS2500069 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2025/06/24New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHS2500068 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2025/06/24New drug · Class 1 | Sonrotoclax薄膜包衣片 · No verified English nameCXHL2500617 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/06/24New drug · Class 1 | Sonrotoclax薄膜包衣片 · No verified English nameCXHL2500616 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/06/24New drug · Class 1 | Sonrotoclax薄膜包衣片 · No verified English nameCXHL2500615 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/06/24New drug · Class 1 | Sonrotoclax薄膜包衣片 · No verified English nameCXHL2500614 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/06/24New drug · Class 1 | BT01001滴眼液 · No verified English nameCXHL2500613 | Suzhou Bi Yang Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/24New drug · Class 1 | BT01001滴眼液 · No verified English nameCXHL2500612 | Suzhou Bi Yang Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/24New drug · Class 1 | BT01001滴眼液 · No verified English nameCXHL2500611 | Suzhou Bi Yang Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/24New drug · Class 1 | ICP-248片 · No verified English nameCXHL2500610 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/24New drug · Class 1 | ICP-248片 · No verified English nameCXHL2500609 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/23Generic · Class 3 | Lysine Acetylsalicylate For InjectionCYHS2502249 | Nanjing Huang Long Bio Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2025/06/23Generic · Class 3 | Lysine Acetylsalicylate For InjectionCYHS2502248 | Nanjing Huang Long Bio Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2025/06/23Generic · Class 3 | Prasugrel Hydrochloride TabletsCYHL2500120 | Chongqing Pharmaceuticals (Group) Co., Ltd. romanized |
55 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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