YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 245 drug applications between 4 May 2025 and 10 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 48 drug names.
2025/05/04 – 2025/05/10
- New acceptances this week
- 245
- Drugs with new generic filings (by drug name, de-duplicated)
- 48
- Accepted this week, now under review
- 16
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
245filings, 66 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 119 |
| Generic | 66 |
| New drug | 48 |
| Import | 10 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 153 |
| TCM | 49 |
| Therapeutic biologic | 37 |
| Prophylactic biologic | 4 |
| 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
48 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Penicillin G Sodium For Injection | 6 | 1 | 2 |
| 2 | Riociguat Tablets | 3 | 1 | 4 |
| 3 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 4 | 黄体酮注射液(Ⅱ) · No verified English name | 2 | 2 | 2 |
| 5 | Nintedanib Esilate Soft Capsules | 2 | 1 | 6 |
| 6 | Carboplatin Injection | 2 | 1 | 10 |
| 7 | Orlistat Capsules | 2 | 1 | 8 |
| 8 | Baricitinib Tablets | 2 | 1 | 32 |
| 9 | 昂丹司琼口溶膜 · No verified English name | 2 | 1 | 2 |
| 10 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
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
151 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 12 | 12 | 0 |
| 2 | Jiangxi Qing Feng Pharma Co., Ltd. romanized | 10 | 9 | 0 |
| 3 | Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | AstraZeneca AB | 6 | 5 | 0 |
| 5 | Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 6 | Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 6 |
| 7 | Shanxi Huang He Zhong Yao Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 5 | 3 | 0 |
| 9 | Shanxi Mai Di Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 3 | 3 | 2 |
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
83 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/10Import · Class 1 | SAR402663注射液 · No verified English nameJXSL2500074 | Sanofi-Aventis Recherche & Développement; SANOFI (CHINA) INVESTMENT CO. LTD |
| 2025/05/10Import · Class 1 | AZD0780薄膜衣片 · No verified English nameJXHL2500106 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/05/10Generic · Class 3 | Diphenhydramine Hydrochloride InjectionCYHS2501704 | Anhui Chang Jiang Pharma Co., Ltd. romanized |
| 2025/05/10Generic · Class 3 | Ketoconazole CreamCYHS2501702 | Bao Long Pharma Co., Ltd. romanized |
| 2025/05/10Generic · Class 3 | 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2501700 | Shijiazhuang Kang Li Pharma Co., Ltd. romanized |
| 2025/05/10Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2501699 | Suzhou Hong Sen Pharma Co., Ltd. romanized |
| 2025/05/10Generic · Class 3 | Furosemide Oral SolutionCYHS2501698 | Hainan Quan Xing Pharmaceutical Co., Ltd. romanized |
| 2025/05/10Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2501697 | Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized |
| 2025/05/10New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2500373 | Tianjin Hua Yu Pharma Co., Ltd. romanized |
| 2025/05/10New drug · Class 1 | 注射用GB268 · No verified English nameCXSL2500372 | Jia He Bio Pharma Co., Ltd. romanized |
| 2025/05/10New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2500371 | Huan Ke (Hebei) Bio Technology Co., Ltd. romanized; Hua Pu Shijiazhuang Pharmaceuticals Co., Ltd. romanized |
| 2025/05/10New drug · Class 3.3 | 德谷门冬双胰岛素注射液 · No verified English nameCXSL2500370 | Yi Fan Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/05/10New drug · Class 1 | IBI3011 · No verified English nameCXSL2500369 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/05/10New drug · Class 1 | 玛仕度肽注射液 · No verified English nameCXHL2500459 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/05/10New drug · Class 1 | 玛仕度肽注射液 · No verified English nameCXHL2500458 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/05/10New drug · Class 1 | 玛仕度肽注射液 · No verified English nameCXHL2500457 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/05/10New drug · Class 1 | DZD8586片 · No verified English nameCXHL2500453 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2025/05/10New drug · Class 1 | 马来酸苏特替尼胶囊 · No verified English nameCXHL2500452 | Jiangsu Mai Du Drug Research and Development Co., Ltd. romanized |
| 2025/05/09Import · Class 3.1 | Risankizumab · No verified English nameJXSL2500073 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/05/09Import · Class 2.1 | Risankizumab · No verified English nameJXSL2500072 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/05/09Generic · Class 3 | Fexofenadine Hydrochloride TabletsCYHS2501681 | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/05/09Generic · Class 3 | Fexofenadine Hydrochloride TabletsCYHS2501680 | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/05/09New drug · Class 1 | 注射用RC278 · No verified English nameCXSL2500368 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2025/05/09New drug · Class 1.2 | AFN1204注射液 · No verified English nameCXSL2500367 | Hefei A Fa Na Bio Technology Co., Ltd. romanized |
| 2025/05/09New drug · Class 1 | IBI130 · No verified English nameCXSL2500366 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/05/09New drug · Class 1.2 | AFN1213注射液 · No verified English nameCXSL2500365 | Hefei A Fa Na Bio Technology Co., Ltd. romanized |
| 2025/05/09New drug · Class 1 | SCTB39-1注射液 · No verified English nameCXSL2500364 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2025/05/09New drug · Class 1 | 注射用VDJ006 · No verified English nameCXSL2500363 | Beijing Wei De Jie Bio Technology Co., Ltd. romanized |
| 2025/05/09New drug · Class 2.4 | 羟乙磺酸达尔西利片 · No verified English nameCXHS2500045 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/05/09New drug · Class 2.4 | 羟乙磺酸达尔西利片 · No verified English nameCXHS2500044 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
53 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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