YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 340 drug applications between 25 October 2024 and 31 October 2024 (data as of 14 November 2026 06:00). Of these, generic applications numbered 100, covering 67 drug names.
2024/10/25 – 2024/10/31
- New acceptances this week
- 340
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- 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
340filings, 100 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 165 |
| Generic | 100 |
| New drug | 49 |
| Unspecified | 13 |
| Import | 10 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 219 |
| TCM | 70 |
| Therapeutic biologic | 37 |
| Biologic | 10 |
| Prophylactic biologic | 4 |
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
67 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 8 | 4 | 58 |
| 2 | Methotrexate Injection | 6 | 1 | 11 |
| 3 | 维生素B6注射液 · No verified English name | 4 | 4 | 9 |
| 4 | Oseltamivir Phosphate For Oral Suspension | 3 | 2 | 2 |
| 5 | Febuxostat Tablets | 3 | 2 | 12 |
| 6 | Crisaborole Ointment | 2 | 2 | 26 |
| 7 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 8 | Brexpiprazole Tablets | 2 | 2 | 31 |
| 9 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 10 | Lactated Ringer's Injection | 2 | 1 | 5 |
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
191 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangdong Sunho Pharmaceutical Co., Ltd. | 35 | 26 | 0 |
| 2 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 21 | 17 | 0 |
| 3 | Novo Nordisk A/S | 15 | 2 | 0 |
| 4 | Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized | 6 | 1 | 6 |
| 5 | Jilin Sheng Shang Cheng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Shandong Qidu Pharmaceutical Co., Ltd. | 4 | 3 | 4 |
| 7 | Amgen Inc. | 4 | 2 | 0 |
| 8 | Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized | 3 | 3 | 3 |
| 9 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Zhongguo Yi Xue Ke College Yi Xue Bio Xue Research Institute romanized | 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
100 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/10/31Generic · Class 3 | 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2403697 | Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; Ji Chuan Pharma Group Co., Ltd. romanized |
| 2024/10/31Generic · Class 3 | Pentoxifylline Modified Release TabletsCYHS2403696 | Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2024/10/31Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2403695 | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2024/10/31Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2403694 | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2024/10/31Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2403691 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Nanchang Li Jian Pharma Co., Ltd. romanized |
| 2024/10/31Generic · Class 3 | Nitroglycerin InjectionCYHS2403689 | Hainan Wei Jian Pharma Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized |
| 2024/10/31Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2403688 | Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanized |
| 2024/10/31Generic · Class 3 | Doxofylline TabletsCYHS2403684 | Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized |
| 2024/10/31Generic · Class 3 | Doxofylline TabletsCYHS2403683 | Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized |
| 2024/10/31New drug · Class 1.1 | HC009合剂 · No verified English nameCXZL2400074 | Beijing Hou Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/31New drug · Class 1 | 注射用芦康沙妥珠单抗 · No verified English nameCXSS2400117 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2024/10/31New drug · Class 1 | PJ008注射液 · No verified English nameCXSL2400745 | Chongqing Pai Jin Bio Technology Co., Ltd. romanized |
| 2024/10/31New drug · Class 2.2 | HB018口溶膜 · No verified English nameCXHL2401151 | Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/31New drug · Class 2.2 | HB018口溶膜 · No verified English nameCXHL2401150 | Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/31New drug · Class 2.2 | HB018口溶膜 · No verified English nameCXHL2401149 | Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/31New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2401148 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2024/10/31New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2401147 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2024/10/30Import · Class 2.2 | Tarlatamab · No verified English nameJXSL2400208 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2024/10/30Import · Class 2.2 | Tarlatamab · No verified English nameJXSL2400207 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2024/10/30Import · Class 2.2 | Tarlatamab · No verified English nameJXSL2400206 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2024/10/30Import · Class 2.3; 2.4 | MRG-001注射液 · No verified English nameJXHL2400259 | MEDREGEN LLC; Hangzhou Tigermed Consulting Co. Ltd. |
| 2024/10/30Generic · Class 3 | Potassium Phosphates InjectionCYHS2403682 | Guangdong Mai De Fa Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/10/30Generic · Class 3 | Metoprolol Succinate Extended-release CapsulesCYHS2403679 | Shanghai Hui Yong Pharmaceutical Co., Ltd. romanized |
| 2024/10/30Generic · Class 3 | Calcium Acetate Oral SolutionCYHS2403678 | Hefei En Rui Te Pharma Co., Ltd. romanized |
| 2024/10/30Generic · Class 3 | Obeticholic Acid TabletsCYHS2403677 | Tai Zhou Fu Dan Zhang Jiang Pharma Co., Ltd. romanized |
| 2024/10/30Generic · Class 3 | Obeticholic Acid TabletsCYHS2403676 | Tai Zhou Fu Dan Zhang Jiang Pharma Co., Ltd. romanized |
| 2024/10/30Generic · Class 3 | 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2400213 | Jiangsu Run Bang Pharma Co., Ltd. romanized |
| 2024/10/30New drug · Class 1.1 | 仙茜颗粒 · No verified English nameCXZL2400073 | Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized |
| 2024/10/30New drug · Class 1.1 | BYS30颗粒 · No verified English nameCXZL2400072 | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized |
| 2024/10/30New drug · Class 1 | OCUL101注射液 · No verified English nameCXSL2400744 | Shenzhen Ou Ke Jian Biopharmaceuticals Technology Co., Ltd. romanized |
70 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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