YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 392 drug applications between 15 May 2025 and 21 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 68 drug names.
2025/05/15 – 2025/05/21
- New acceptances this week
- 392
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- Accepted this week, now under review
- 51
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
392filings, 97 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 206 |
| Generic | 97 |
| New drug | 55 |
| Import | 19 |
| Unspecified | 10 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 249 |
| TCM | 80 |
| Therapeutic biologic | 55 |
| Prophylactic biologic | 5 |
| Biologic | 3 |
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 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 4 | 2 | 22 |
| 2 | Risperidone Oral Solution | 4 | 1 | 6 |
| 3 | Calcium Acetate Oral Solution | 4 | 1 | 1 |
| 4 | Aripiprazole Oral Solution | 4 | 1 | 4 |
| 5 | Glucosamine Sulfate Capsules | 3 | 3 | 51 |
| 6 | 维立西呱片 · No verified English name | 3 | 1 | 8 |
| 7 | 维生素B12注射液 · No verified English name | 2 | 2 | 6 |
| 8 | 丙戊酸钠缓释微片 · No verified English name | 2 | 1 | 0 |
| 9 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 10 | Levofloxacin and Sodium Chloride Injection | 2 | 1 | 14 |
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
234 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 17 | 16 | 0 |
| 2 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 13 | 4 | 13 |
| 3 | Hong Tao Kai Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | AstraZeneca AB | 6 | 3 | 0 |
| 5 | Guo Yao Group De Zhong (Fo Shan) Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Changzhou Pharmaceutical Factory Co., Ltd. romanized | 5 | 2 | 5 |
| 7 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized | 5 | 2 | 0 |
| 8 | CISEN PHARMACEUTICAL CO., LTD. | 5 | 2 | 1 |
| 9 | Hainan Hai Li Pharmaceutical Co., Ltd. romanized | 4 | 4 | 1 |
| 10 | Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized | 4 | 3 | 2 |
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
118 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/21Import · Class 3.1 | 度普利尤单抗注射液 · No verified English nameJXSS2500063 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2025/05/21Import · Class 3.1 | 度普利尤单抗注射液 · No verified English nameJXSS2500062 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2025/05/21Import · Class 1 | 注射用Felzartamab · No verified English nameJXSL2500079 | Biogen Idec Research Limited |
| 2025/05/21Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2501839 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2025/05/21Generic · Class 3 | 美沙拉秦肠溶缓释胶囊 · No verified English nameCYHS2501835 | Gan Li Pharma Shandong Co., Ltd. romanized |
| 2025/05/21Generic · Class 3 | Bilastine Oral SolutionCYHS2501831 | Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/05/21Generic · Class 3 | Colesevelam Hydrochloride TabletsCYHS2501828 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2025/05/21Generic · Class 3 | 丙戊酸钠缓释微片 · No verified English nameCYHL2500095 | Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized |
| 2025/05/21Generic · Class 3 | 丙戊酸钠缓释微片 · No verified English nameCYHL2500094 | Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized |
| 2025/05/21New drug · Class 1.4 | 24价肺炎球菌结合疫苗 · No verified English nameCXSL2500410 | Suzhou Ju Wei Bio Technology Co., Ltd. romanized |
| 2025/05/21New drug · Class 1 | 注射用MHB042C · No verified English nameCXSL2500409 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2025/05/21New drug · Class 1 | 人牙囊间充质干细胞注射液 · No verified English nameCXSL2500408 | Chengdu Shi Lian Kang Jian Bio Technology Co., Ltd. romanized |
| 2025/05/21New drug · Class 1 | 注射用LB4330 · No verified English nameCXSL2500407 | Shanghai Jian Xin Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/21New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2500405 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/05/21New drug · Class 1 | 注射用重组抗PD1/TIM3人源化双特异抗体 · No verified English nameCXSL2500404 | Shanghai Jian Xin Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/21New drug · Class 1 | 注射用SHR-A2102 · No verified English nameCXSL2500403 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/05/21New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2500402 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/05/21New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2500401 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/05/21New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2500400 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/05/21New drug · Class 2.2 | CB345 · No verified English nameCXHL2500495 | Hangzhou Cheng Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/21New drug · Class 2.2 | CB345 · No verified English nameCXHL2500494 | Hangzhou Cheng Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/21New drug · Class 1 | HS-10516胶囊 · No verified English nameCXHL2500493 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/21New drug · Class 1 | HS-10516胶囊 · No verified English nameCXHL2500492 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/21New drug · Class 1 | YL-13027片 · No verified English nameCXHL2500491 | Shanghai Ying Li Pharma Co., Ltd. romanized |
| 2025/05/21New drug · Class 1 | YL-13027片 · No verified English nameCXHL2500490 | Shanghai Ying Li Pharma Co., Ltd. romanized |
| 2025/05/20Import · Class 2.2 | Tremelimumab注射液 · No verified English nameJXSL2500078 | MedImmune LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2025/05/20Import · Class 2.2 | 度伐利尤单抗注射液 · No verified English nameJXSL2500077 | MedImmune LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2025/05/20Import · Class 1 | AZD1613注射液 · No verified English nameJXSL2500076 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/05/20Import · Class 2.4 | 氘可来昔替尼片 · No verified English nameJXHS2500059 | Bristol-Myers Squibb Pharma EEIG; PATHEON INC.; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/05/20Import · Class 1 | AZD5305 · No verified English nameJXHL2500119 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
88 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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