YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 403 drug applications between 12 March 2025 and 18 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 66 drug names.
2025/03/12 – 2025/03/18
- New acceptances this week
- 403
- Drugs with new generic filings (by drug name, de-duplicated)
- 66
- Accepted this week, now under review
- 25
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
403filings, 95 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 193 |
| Generic | 95 |
| New drug | 53 |
| Import | 22 |
| Import re-registration | 22 |
| Unspecified | 18 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 300 |
| TCM | 52 |
| Therapeutic biologic | 44 |
| Prophylactic biologic | 5 |
| Biologic | 2 |
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
66 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 地氯雷他定口服溶液 · No verified English name | 4 | 2 | 26 |
| 2 | Sacubitril Valsartan Sodium Tablets | 4 | 2 | 70 |
| 3 | Lactulose Oral Solution | 3 | 2 | 34 |
| 4 | Riociguat Tablets | 3 | 1 | 4 |
| 5 | Levofloxacin and Sodium Chloride Injection | 3 | 1 | 14 |
| 6 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 8 |
| 7 | Famotidine Injection | 2 | 1 | 8 |
| 8 | Hydrocortisone Sodium Succinate for Injection | 2 | 1 | 16 |
| 9 | Ciclosporin Soft Capsules | 2 | 1 | 2 |
| 10 | Edoxaban Tosilate Tablets | 2 | 1 | 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
220 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nan Yang Pu Kang Heng Wang Pharma Co., Ltd. romanized | 17 | 16 | 0 |
| 2 | Bracco Imaging S.P.A. | 13 | 1 | 0 |
| 3 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | Hunan Jiudian Pharmaceutical Co., Ltd | 6 | 5 | 0 |
| 5 | Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 3 | 0 |
| 7 | AstraZeneca AB | 5 | 3 | 0 |
| 8 | Guangzhou Ze Sheng Pharma Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Zhongguo Ke College Shanghai Drug Research Institute romanized | 4 | 3 | 0 |
| 10 | Sanofi Winthrop Industrie | 4 | 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
110 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/18Import · Class 2.4 | 地非法林注射液 · No verified English nameJXHL2500049 | Vifor Fresenius Medical Care Renal Pharma Ltd.; Zhejiang Medical Technology Development Co. LTD. |
| 2025/03/18Import · Class 1 | VSA001注射液 · No verified English nameJXHL2500048 | Arrowhead Pharmaceuticals Inc.; Sanofi (China) Investment Co. Ltd. |
| 2025/03/18Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2501100 | Henan Li Hua Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2025/03/18Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2501099 | Henan Li Hua Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2025/03/18Generic · Class 3 | Propafenone Hydrochloride InjectionCYHS2501097 | Anhui Chang Jiang Pharma Co., Ltd. romanized |
| 2025/03/18Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2501096 | Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2025/03/18Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2501095 | Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2025/03/18Generic · Class 3 | Doxycycline Hyclate for InjectionCYHS2501092 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2025/03/18Generic · Class 3 | Labetalol Hydrochloride InjectionCYHS2501090 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/03/18Generic · Class 3 | Labetalol Hydrochloride InjectionCYHS2501089 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/03/18Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2501088 | Henan Pu Rui Pharma Co., Ltd. romanized |
| 2025/03/18Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2501087 | Henan Pu Rui Pharma Co., Ltd. romanized |
| 2025/03/18New drug · Class 1 | IBI363 · No verified English nameCXSL2500233 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/03/18New drug · Class 1 | IBI363 · No verified English nameCXSL2500232 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/03/18New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2500231 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/03/18New drug · Class 1 | 注射用SHR-A1811 · No verified English nameCXSL2500230 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/03/18New drug · Class 2.5 | 吸附组分无细胞百白破(减剂量)联合疫苗 · No verified English nameCXSL2500229 | Zhongguo Yi Xue Ke College Yi Xue Bio Xue Research Institute romanized |
| 2025/03/18New drug · Class 2.5 | 吸附组分无细胞百白破(减剂量)联合疫苗 · No verified English nameCXSL2500228 | Zhongguo Yi Xue Ke College Yi Xue Bio Xue Research Institute romanized |
| 2025/03/18New drug · Class 1 | TP1001 片 · No verified English nameCXHL2500300 | Sheng Yuan Ze Tong (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2025/03/18New drug · Class 1 | TP1001 片 · No verified English nameCXHL2500299 | Sheng Yuan Ze Tong (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2025/03/18New drug · Class 1 | 苹果酸法米替尼胶囊 · No verified English nameCXHL2500298 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/03/18New drug · Class 1 | RFUS-949片 · No verified English nameCXHL2500297 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/03/18New drug · Class 1 | RFUS-949片 · No verified English nameCXHL2500296 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/03/18New drug · Class 1 | GST-HG131片 · No verified English nameCXHL2500295 | Fujian Guang Sheng Zhong Lin Bio Technology Co., Ltd. romanized |
| 2025/03/18New drug · Class 1 | GST-HG131片 · No verified English nameCXHL2500294 | Fujian Guang Sheng Zhong Lin Bio Technology Co., Ltd. romanized |
| 2025/03/18New drug · Class 1 | 奈瑞可韦片 · No verified English nameCXHL2500293 | Fujian Guang Sheng Zhong Lin Bio Technology Co., Ltd. romanized |
| 2025/03/18New drug · Class 1 | 奈瑞可韦片 · No verified English nameCXHL2500292 | Fujian Guang Sheng Zhong Lin Bio Technology Co., Ltd. romanized |
| 2025/03/17Import · Class 1 | [225Ac]Ac-PSMA-617注射液 · No verified English nameJXHL2500047 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/03/15Import · Class 2.2 | 度普利尤单抗注射液 · No verified English nameJXSS2500026 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2025/03/15Import · Class 2.2 | 度普利尤单抗注射液 · No verified English nameJXSS2500025 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
80 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.