YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 363 drug applications between 29 July 2024 and 4 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 103, covering 78 drug names.
2024/07/29 – 2024/08/04
- New acceptances this week
- 363
- Drugs with new generic filings (by drug name, de-duplicated)
- 78
- Accepted this week, now under review
- 12
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
363filings, 103 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 182 |
| Generic | 103 |
| New drug | 52 |
| Import | 14 |
| Unspecified | 8 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 233 |
| TCM | 64 |
| Therapeutic biologic | 57 |
| Prophylactic biologic | 7 |
| 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
78 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Azilsartan Medoxomil Potassium Tablets | 4 | 2 | 35 |
| 2 | Potassium Chloride Oral Solution | 3 | 2 | 11 |
| 3 | Bromhexine Hydrochloride Oral Solution | 3 | 2 | 22 |
| 4 | Neostigmine Methylsulfate Injection | 3 | 1 | 4 |
| 5 | Magnesium Sulfate Injection | 3 | 1 | 7 |
| 6 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 7 | Pediatric Faropenem Sodium Granules | 2 | 2 | 2 |
| 8 | Isavuconazonium Sulfate for Injection | 2 | 2 | 15 |
| 9 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
| 10 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
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
238 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hunan San Xue Pharma Co., Ltd. romanized | 14 | 11 | 0 |
| 2 | Ha Yao Group Pharmaceutical Factory romanized | 11 | 2 | 0 |
| 3 | Shen Wei Pharma Group Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Guangdong Ke Hong Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 5 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Shanghai Wan Shi Cheng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Janssen Research & Development LLC | 4 | 2 | 0 |
| 8 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized | 4 | 2 | 3 |
| 9 | Eli Lilly and Company | 4 | 1 | 0 |
| 10 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 1 | 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
107 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/08/03Import · Class 2.2 | 佩索利单抗注射液 · No verified English nameJXSL2400145 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2024/08/03Import · Class 1 | HDP-101 · No verified English nameJXSL2400144 | Heidelberg Pharma AG; Hangzhou Zhongmei HuaDong Pharmaceutical Co. Ltd. |
| 2024/08/03Import · Class 1 | ASP2138注射液 · No verified English nameJXSL2400143 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2024/08/03Import · Class 1 | JNJ-78278343注射液 · No verified English nameJXSL2400142 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/08/03Import · Class 1 | JNJ-78278343注射液 · No verified English nameJXSL2400141 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/08/03Generic · Class 3 | 昂丹司琼口溶膜 · No verified English nameCYHS2402479 | Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized |
| 2024/08/03Generic · Class 3 | 昂丹司琼口溶膜 · No verified English nameCYHS2402478 | Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized |
| 2024/08/03Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2402477 | Anhui Ji Ren Pharma Co., Ltd. romanized |
| 2024/08/03Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2402475 | Zhejiang Ling Chuang You Pin Pharma Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized |
| 2024/08/03Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2402474 | Zhejiang Ling Chuang You Pin Pharma Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized |
| 2024/08/03Generic · Class 3 | 头孢地尼干混悬剂 · No verified English nameCYHS2402472 | Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized |
| 2024/08/03Generic · Class 3 | Etoposide InjectionCYHS2402468 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2024/08/03Generic · Class 3 | 阿巴帕肽注射液 · No verified English nameCYHL2400159 | Qilu Pharmaceutical Co., Ltd. |
| 2024/08/03New drug · Class 1 | GQ1005注射液 · No verified English nameCXSL2400522 | Qi De Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2024/08/03New drug · Class 1 | 注射用PTX-912 · No verified English nameCXSL2400521 | Bo Zhi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2024/08/03New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2400520 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized |
| 2024/08/03New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2400519 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized |
| 2024/08/03New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2400518 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized |
| 2024/08/03New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2400517 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized |
| 2024/08/03New drug · Class 1 | YFQLXB-UC01注射液 · No verified English nameCXSL2400516 | Shandong Sheng Qi Lu Xi Bao Zhi Liao Gong Cheng Technology Co., Ltd. romanized |
| 2024/08/03New drug · Class 1 | ZM001注射液 · No verified English nameCXSL2400515 | Xiamen Zai Miao Bio Technology Co., Ltd. romanized |
| 2024/08/02Import · Class 3.1 | elranatamab · No verified English nameJXSL2400140 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2024/08/02Import · Class 3.1 | 注射用sotatercept · No verified English nameJXSL2400139 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2024/08/02Import · Class 3.1 | 注射用sotatercept · No verified English nameJXSL2400138 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2024/08/02Generic · Class 3 | Foscarnet Sodium InjectionCYHS2402461 | Chi Feng Yuan Sheng Pharma Co., Ltd. romanized |
| 2024/08/02Generic · Class 3 | Amisulpride Oral SolutionCYHS2402458 | Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized |
| 2024/08/02Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2402451 | Beijing SL Pharmaceutical Co., Ltd. |
| 2024/08/02Generic · Class 3 | 布美他尼片 · No verified English nameCYHS2402450 | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2024/08/02New drug · Class 1.2 | 冻干带状疱疹mRNA疫苗 · No verified English nameCXSL2400514 | Wuhan Rui Ji Bio Technology Co., Ltd. romanized; Shenzhen Rui Ji Bio Technology Co., Ltd. romanized |
| 2024/08/02New drug · Class 1 | IHS002赋能人脐带间充质干细胞注射液 · No verified English nameCXSL2400513 | Wuxi Hua Tai Innovation Yao Technology Research Institute 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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