YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 506 drug applications between 9 October 2024 and 15 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 147, covering 108 drug names.
2024/10/09 – 2024/10/15
- New acceptances this week
- 506
- Drugs with new generic filings (by drug name, de-duplicated)
- 108
- Accepted this week, now under review
- 2
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
506filings, 147 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 222 |
| Generic | 147 |
| New drug | 77 |
| Import | 35 |
| Import re-registration | 13 |
| Unspecified | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 358 |
| TCM | 77 |
| Therapeutic biologic | 65 |
| Biologic | 4 |
| Prophylactic 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
108 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Fusidic Acid Cream | 6 | 3 | 15 |
| 2 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 3 | 3 | 8 |
| 3 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 4 | Bupivacaine Hydrochloride Injection | 3 | 1 | 4 |
| 5 | Fudosteine oral solution | 3 | 1 | 7 |
| 6 | Dasatinib Tablets | 3 | 1 | 4 |
| 7 | Potassium Chloride Oral Solution | 2 | 2 | 11 |
| 8 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 9 | Iguratimod Tablets | 2 | 2 | 23 |
| 10 | ω-3 Fish Oil Fat Emulsion Injection | 2 | 1 | 6 |
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
301 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bristol-Myers Squibb Pharma EEIG | 11 | 4 | 0 |
| 2 | Guizhou Ke Lun Pharma Co., Ltd. romanized | 9 | 3 | 1 |
| 3 | Janssen-Cilag International NV | 8 | 6 | 0 |
| 4 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 7 | 1 | 0 |
| 5 | Bard Pharmaceuticals Limited | 6 | 6 | 0 |
| 6 | Jiangsu Shen Hua Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | AstraZeneca AB | 5 | 4 | 0 |
| 8 | Merck Sharp & Dohme B.V. | 5 | 3 | 0 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 10 | Eli Lilly and Company | 5 | 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
161 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/10/15Import · Class 1 | Aficamten片 · No verified English nameJXHS2400085 | Cytokinetics Incorporated; Patheon Inc.; Sanofi (China) Investment Co. Ltd. |
| 2024/10/15Import · Class 1 | Bepirovirsen 注射液 · No verified English nameJXHL2400246 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2024/10/15Import · Class 1 | Daplusiran/Tomligisiran 注射液 · No verified English nameJXHL2400245 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2024/10/15Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2403475 | Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2024/10/15Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2403474 | Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2024/10/15Generic · Class 3 | 聚乙二醇3350散 · No verified English nameCYHS2403471 | Ma Ying Long Pharma Group Co., Ltd. romanized |
| 2024/10/15Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2403470 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized |
| 2024/10/15Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2403469 | Hunan Bai Qi He Drug Research and Development Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2024/10/15Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2403468 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized |
| 2024/10/15Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2403464 | Bai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanized; Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized |
| 2024/10/15Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2403457 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Sui Cheng Pharma Co., Ltd. romanized |
| 2024/10/15Generic · Class 3 | Fudosteine oral solutionCYHS2403456 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2024/10/15Generic · Class 3 | Fudosteine oral solutionCYHS2403455 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2024/10/15Generic · Class 3 | Fudosteine oral solutionCYHS2403454 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2024/10/15Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2403453 | Heilongjiang Sheng Zhi Run Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/10/15Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2403450 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/10/15Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2403449 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/10/15Generic · Class 3 | Tartilelin TabletsCYHL2400200 | Chengdu Jian Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/15New drug · Class 2.2 | 注射用维迪西妥单抗 · No verified English nameCXSS2400111 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2024/10/15New drug · Class 1 | YFQLXB-UC01注射液 · No verified English nameCXSL2400695 | Shandong Sheng Qi Lu Xi Bao Zhi Liao Gong Cheng Technology Co., Ltd. romanized |
| 2024/10/15New drug · Class 1 | GNC-038四特异性抗体注射液 · No verified English nameCXSL2400694 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2024/10/15New drug · Class 1 | GNC-038四特异性抗体注射液 · No verified English nameCXSL2400693 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2024/10/15New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2401081 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. |
| 2024/10/15New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2401080 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. |
| 2024/10/15New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2401079 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. |
| 2024/10/15New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2401078 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. |
| 2024/10/15New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2401077 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. |
| 2024/10/15New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2401076 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. |
| 2024/10/15New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2401075 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. |
| 2024/10/15New drug · Class 1 | TQH3906胶囊 · No verified English nameCXHL2401074 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
131 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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