YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 362 drug applications between 24 October 2024 and 30 October 2024 (data as of 14 November 2026 06:00). Of these, generic applications numbered 103, covering 68 drug names.
2024/10/24 – 2024/10/30
- New acceptances this week
- 362
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- 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
362filings, 103 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 175 |
| Generic | 103 |
| New drug | 53 |
| Import | 16 |
| Unspecified | 12 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 231 |
| TCM | 72 |
| Therapeutic biologic | 43 |
| Biologic | 10 |
| Prophylactic biologic | 6 |
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
68 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 | Febuxostat Tablets | 3 | 2 | 12 |
| 5 | Crisaborole Ointment | 2 | 2 | 26 |
| 6 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 7 | Brexpiprazole Tablets | 2 | 2 | 31 |
| 8 | 氯化钙注射液 · No verified English name | 2 | 2 | 6 |
| 9 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 10 | Iguratimod Tablets | 2 | 2 | 23 |
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
210 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangdong Sunho Pharmaceutical Co., Ltd. | 33 | 24 | 0 |
| 2 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 15 | 13 | 0 |
| 3 | Novo Nordisk A/S | 15 | 2 | 0 |
| 4 | Jilin Sheng Shang Cheng Pharma Co., Ltd. romanized | 7 | 6 | 0 |
| 5 | Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized | 6 | 1 | 6 |
| 6 | Hua Chuan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Shandong Qidu Pharmaceutical Co., Ltd. | 4 | 3 | 4 |
| 8 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Shanghai Min Wei Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized | 3 | 3 | 3 |
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
107 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2024/10/30New drug · Class 1 | OCUL101注射液 · No verified English nameCXSL2400743 | Shenzhen Ou Ke Jian Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/30New drug · Class 1 | OCUL101注射液 · No verified English nameCXSL2400742 | Shenzhen Ou Ke Jian Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/30New drug · Class 2.2 | 恩朗苏拜单抗注射液 · No verified English nameCXSL2400741 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2024/10/30New drug · Class 1 | HM2002注射液 · No verified English nameCXSL2400740 | Shanghai Huan Ma Biopharmaceuticals Co., Ltd. romanized |
| 2024/10/30New drug · Class 1 | BAT1308注射液 · No verified English nameCXSL2400739 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2024/10/30New drug · Class 1 | 注射用BAT8007 · No verified English nameCXSL2400738 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2024/10/30New drug · Class 1 | RC148注射液 · No verified English nameCXSL2400737 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2024/10/30New drug · Class 3.2 | 重组人促卵泡激素-CTP融合蛋白注射液 · No verified English nameCXSL2400736 | Suzhou Jing Ze Biopharmaceuticals Co., Ltd. romanized |
| 2024/10/30New drug · Class 2.2 | HXASP028 · No verified English nameCXHL2401146 | Guangxi Shan He Bai Sheng Technology Co., Ltd. romanized |
| 2024/10/30New drug · Class 2.2 | HXASP028 · No verified English nameCXHL2401145 | Guangxi Shan He Bai Sheng Technology Co., Ltd. romanized |
| 2024/10/30New drug · Class 1 | HRN01片 · No verified English nameCXHL2401144 | Beijing Hua Rui Ding Xin Technology Co., Ltd. romanized |
| 2024/10/30New drug · Class 1 | HRN01片 · No verified English nameCXHL2401143 | Beijing Hua Rui Ding Xin Technology Co., Ltd. romanized |
| 2024/10/29Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2403665 | Henan Li Heng Pharmaceuticals Technology Co., Ltd. romanized; Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized |
| 2024/10/29Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2403660 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2024/10/29Generic · Class 3 | Cetylpyridinium Chloride Buccal TabletsCYHS2403659 | Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Rui Hua (Zhong Shan) Pharmaceutical Co., Ltd. romanized |
| 2024/10/29Generic · Class 3 | 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2403657 | Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized |
| 2024/10/29Generic · Class 3 | Ibuprofen InjectionCYHL2400212 | Hua Zhong Pharma Co., Ltd. romanized |
77 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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