YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 393 drug applications between 8 March 2025 and 14 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 119, covering 80 drug names.
2025/03/08 – 2025/03/14
- New acceptances this week
- 393
- Drugs with new generic filings (by drug name, de-duplicated)
- 80
- Accepted this week, now under review
- 24
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
393filings, 119 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 166 |
| Generic | 119 |
| New drug | 41 |
| Import re-registration | 25 |
| Import | 22 |
| Unspecified | 20 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 319 |
| TCM | 36 |
| Therapeutic biologic | 32 |
| 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
80 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 9 | 4 | 70 |
| 2 | 地氯雷他定口服溶液 · No verified English name | 4 | 2 | 26 |
| 3 | Mivacurium Chloride Injection | 4 | 2 | 3 |
| 4 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 5 | Lactulose Oral Solution | 3 | 2 | 34 |
| 6 | 甲氧氯普胺片 · No verified English name | 3 | 2 | 3 |
| 7 | Riociguat Tablets | 3 | 1 | 4 |
| 8 | Levofloxacin and Sodium Chloride Injection | 3 | 1 | 14 |
| 9 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 2 | 2 | 9 |
| 10 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
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
221 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nan Yang Pu Kang Heng Wang Pharma Co., Ltd. romanized | 18 | 17 | 1 |
| 2 | Bracco Imaging S.P.A. | 13 | 1 | 0 |
| 3 | Fresenius Kabi Deutschland GmbH | 12 | 2 | 0 |
| 4 | Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Bayer AG | 6 | 3 | 0 |
| 6 | Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 7 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 3 | 0 |
| 8 | AstraZeneca AB | 5 | 3 | 0 |
| 9 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 5 | 2 | 2 |
| 10 | Hubei Wu Shi Pharma Co., Ltd. romanized | 4 | 3 | 4 |
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
93 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/14Import · Class 1 | TQJ230注射液 · No verified English nameJXHL2500044 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/03/14Import · Class 1 | ELVN-001胶囊 · No verified English nameJXHL2500043 | Enliven Therapeutics Inc.; R&G PharmaStudies Co. Ltd. |
| 2025/03/14Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2501064 | Shandong Yi Kang Pharma Co., Ltd. romanized |
| 2025/03/14Generic · Class 3 | Famotidine InjectionCYHS2501060 | Anhui Mei Lai Pharma Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized |
| 2025/03/14Generic · Class 3 | 甲氧氯普胺片 · No verified English nameCYHS2501059 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/03/14Generic · Class 3 | Famotidine InjectionCYHS2501058 | Anhui Mei Lai Pharma Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized |
| 2025/03/14Generic · Class 3 | Hydrotalcite SuspensionCYHS2501057 | Anhui Hao Yu Biopharmaceutical Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2025/03/14Generic · Class 3 | 多种维生素注射液(13)(10/3) · No verified English nameCYHS2501056 | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized |
| 2025/03/14Generic · Class 3 | Furosemide Oral SolutionCYHS2501054 | Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Nanchang Li Jian Pharma Co., Ltd. romanized |
| 2025/03/14Generic · Class 3 | Cytarabine InjectionCYHS2501052 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2025/03/14Generic · Class 3 | Cytarabine InjectionCYHS2501051 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2025/03/14New drug · Class 1.1 | 六味地黄苷糖片 · No verified English nameCXZS2500011 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2025/03/14New drug · Class 1 | SPGL008注射液 · No verified English nameCXSL2500223 | Shenzhen Sai Bao Er Bio Pharma Co., Ltd. romanized |
| 2025/03/14New drug · Class 1 | HMPL-306片 · No verified English nameCXHL2500282 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/03/14New drug · Class 1 | HMPL-306片 · No verified English nameCXHL2500281 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/03/14New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHL2500280 | Jiangxi Yuan Chao Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/14New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHL2500279 | Jiangxi Yuan Chao Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/14New drug · Class 2.4 | Potassium Sodium Hydrogen Citrate GranulesCXHL2500278 | Shenyang Xin Rui Pharmaceutical Co., Ltd. romanized |
| 2025/03/13Import · Class 3.1 | 注射用维替索妥尤单抗 · No verified English nameJXSS2500023 | Seagen Inc.; Baxter Oncology GmbH; Zai Lab(Shanghai) Co. Ltd |
| 2025/03/13Import · Class 1 | MK-7240注射液 · No verified English nameJXSL2500037 | Merck Sharp & Dohme LLC; Name not romanized |
| 2025/03/13Import · Class 1 | SAR441566 · No verified English nameJXHL2500042 | Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd. |
| 2025/03/13Import · Class 1 | LY3549492片 · No verified English nameJXHL2500041 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/03/13Import · Class 1 | LY3549492片 · No verified English nameJXHL2500040 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/03/13Import · Class 1 | LY3549492片 · No verified English nameJXHL2500039 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/03/13Import · Class 1 | LY3549492片 · No verified English nameJXHL2500038 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/03/13Generic · Class 3 | 盐酸肾上腺素注射液 · No verified English nameCYHS2501047 | Anhui Chang Jiang Pharma Co., Ltd. romanized |
| 2025/03/13Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2501043 | Chengdu Yao Yi Li Kang Pharmaceuticals Technology Co., Ltd. romanized; Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanized |
| 2025/03/13Generic · Class 3 | Furosemide TabletsCYHS2501040 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/03/13Generic · Class 3 | 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2501039 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2025/03/13Generic · Class 3 | 碘解磷定注射液 · No verified English nameCYHS2501036 | Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized |
63 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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