YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 156 drug applications between 28 April 2024 and 4 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 36 drug names.
2024/04/28 – 2024/05/04
- New acceptances this week
- 156
- Drugs with new generic filings (by drug name, de-duplicated)
- 36
- Accepted this week, now under review
- 0
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
156filings, 44 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 68 |
| Generic | 44 |
| New drug | 29 |
| Import re-registration | 8 |
| Unspecified | 5 |
| Import | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 91 |
| TCM | 38 |
| Therapeutic biologic | 24 |
| Biologic | 2 |
| Prophylactic biologic | 1 |
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
36 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 3 | 1 | 23 |
| 2 | Pregabalin Oral Solution | 3 | 1 | 5 |
| 3 | Fluvoxamine Maleate Tablets | 2 | 2 | 0 |
| 4 | Perindopril arginine and amlodipine besylate tablets | 2 | 1 | 3 |
| 5 | 复方聚乙二醇电解质散(Ⅱ) · No verified English name | 2 | 1 | 4 |
| 6 | Moxifloxacin Hydrochloride Eye Drops | 2 | 1 | 4 |
| 7 | Itraconazole Oral Solution | 1 | 1 | 1 |
| 8 | Diquafosol Sodium Eye Drops | 1 | 1 | 5 |
| 9 | Perindopril arginine and amlodipine besylate tablets | 1 | 1 | 0 |
| 10 | Perindopril Arginine and Amlodipine Besylate Tablets(III) | 1 | 1 | 3 |
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
106 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Yan Huang Ben Cao Pharma Co., Ltd. romanized | 12 | 12 | 0 |
| 2 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized | 8 | 1 | 0 |
| 3 | BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED | 4 | 4 | 0 |
| 4 | Shaanxi Jun He Run Kang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | Jiangxi Shimei Pharmaceutical Co., Ltd | 4 | 3 | 4 |
| 6 | Takeda Pharmaceutical Company Limited | 4 | 1 | 0 |
| 7 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized | 3 | 3 | 0 |
| 8 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 3 | 2 | 0 |
| 9 | Hainan Si Da Pharmaceutical Co., Ltd. romanized | 3 | 1 | 3 |
| 10 | Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 3 | 1 | 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
49 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/05/01Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2400084 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2024/05/01New drug · Class 1 | CNK-UT002细胞注射液 · No verified English nameCXSL2400284 | Yi Zun Biopharmaceuticals (Zhejiang) Co., Ltd. romanized |
| 2024/05/01New drug · Class 1 | 注射用sacituzumab tirumotecan · No verified English nameCXSL2400283 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2024/05/01New drug · Class 1 | 酒石酸泰贝西利胶囊 · No verified English nameCXHS2400039 | Bei Da Pharma Co., Ltd. romanized |
| 2024/05/01New drug · Class 1 | SGB-3908注射液 · No verified English nameCXHL2400426 | Suzhou Sheng Yin Biopharmaceuticals Co., Ltd. romanized |
| 2024/05/01New drug · Class 2.2 | HZ031口溶膜 · No verified English nameCXHL2400425 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/04/30Import · Class 1 | ASP2138注射液 · No verified English nameJXSL2400083 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2024/04/30Generic · Class 3 | 头孢克肟颗粒 · No verified English nameCYHS2401322 | Zhejiang AngLiKang Pharmaceutical CO.,LTD. |
| 2024/04/30Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2401319 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2024/04/30Generic · Class 3 | Ambroxol Hydrochloride DropsCYHS2401318 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/04/30Generic · Class 3 | 硫酸沙丁胺醇糖浆 · No verified English nameCYHS2401315 | Hainan Wan Wei Pharmaceutical Co., Ltd. romanized |
| 2024/04/30Generic · Class 3 | Pregabalin Oral SolutionCYHS2401314 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2024/04/30Generic · Class 3 | Bilastine Oral SolutionCYHS2401313 | Shenzhen Shi Bei Mei Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2024/04/30Generic · Class 3 | Pregabalin Oral SolutionCYHS2401312 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2024/04/30Generic · Class 3 | Pregabalin Oral SolutionCYHS2401311 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2024/04/30Generic · Class 3 | Epinephrine InjectionCYHS2401310 | Wuhan Jiu An Drug Research Institute Co., Ltd. romanized; Wuhan Jiu An Pharma Co., Ltd. romanized |
| 2024/04/30Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2401309 | CISEN PHARMACEUTICAL CO., LTD. |
| 2024/04/30Generic · Class 3 | 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2401308 | Shaanxi Li Cai Pharma Co., Ltd. romanized; Yang Ling Ke Sen Biopharmaceutical Co., Ltd. romanized |
| 2024/04/30Generic · Class 3 | 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2401307 | Shaanxi Li Cai Pharma Co., Ltd. romanized; Yang Ling Ke Sen Biopharmaceutical Co., Ltd. romanized |
| 2024/04/30Generic · Class 3 | Azithromycin Eye DropsCYHL2400080 | Shenzhen Xin Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/04/30New drug · Class 1.1 | 清降和胃颗粒 · No verified English nameCXZL2400022 | Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized |
| 2024/04/30New drug · Class 1 | SQ-22031滴眼液 · No verified English nameCXSL2400282 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2024/04/30New drug · Class 1 | SQ-22031滴眼液 · No verified English nameCXSL2400281 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2024/04/30New drug · Class 1 | 注射用sacituzumab tirumotecan · No verified English nameCXSL2400280 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2024/04/30New drug · Class 1 | SQ-22031滴眼液 · No verified English nameCXSL2400279 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2024/04/30New drug · Class 1 | SQ-22031滴眼液 · No verified English nameCXSL2400278 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2024/04/30New drug · Class 1 | PM8002注射液 · No verified English nameCXSL2400277 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2024/04/30New drug · Class 1 | PM1009注射液 · No verified English nameCXSL2400276 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2024/04/30New drug · Class 1 | SQ-22031滴眼液 · No verified English nameCXSL2400275 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2024/04/30New drug · Class 1 | SQ-22031滴眼液 · No verified English nameCXSL2400274 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
19 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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