YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 453 drug applications between 11 June 2025 and 17 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 125, covering 88 drug names.
2025/06/11 – 2025/06/17
- New acceptances this week
- 453
- Drugs with new generic filings (by drug name, de-duplicated)
- 88
- Accepted this week, now under review
- 71
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
453filings, 125 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 182 |
| Generic | 125 |
| New drug | 71 |
| Import | 52 |
| Unspecified | 12 |
| Import re-registration | 10 |
| Medical device (joint review) | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 282 |
| Therapeutic biologic | 85 |
| TCM | 75 |
| Biologic | 7 |
| Prophylactic biologic | 2 |
| In vitro diagnostic reagent | 1 |
| Unspecified | 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
88 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Injection | 15 | 15 | 53 |
| 2 | Brexpiprazole Tablets | 4 | 2 | 31 |
| 3 | 苯磺酸左氨氯地平片 · No verified English name | 4 | 2 | 45 |
| 4 | Sacubitril Valsartan Sodium Tablets | 3 | 2 | 70 |
| 5 | 中性低钙腹膜透析液(碳酸氢盐-G4.25%) · No verified English name | 2 | 2 | 1 |
| 6 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 7 | Acetylcysteine Oral Solution | 2 | 1 | 11 |
| 8 | Lactulose Oral Solution | 2 | 1 | 34 |
| 9 | Carbidopa and Levodopa Sustained-release Tablets | 2 | 1 | 2 |
| 10 | Perindopril tert-Butylamine Tablets | 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
273 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Merck Sharp & Dohme B.V. | 22 | 1 | 0 |
| 2 | Henan Ying Feng Pharmaceuticals Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Rui Yang Pharmaceutical Co., Ltd. romanized | 7 | 2 | 0 |
| 5 | AstraZeneca AB | 6 | 3 | 0 |
| 6 | Amgen Inc. | 6 | 1 | 0 |
| 7 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 5 | 4 |
| 8 | Name not romanized | 5 | 3 | 0 |
| 9 | Pfizer Inc. | 5 | 2 | 0 |
| 10 | Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized | 5 | 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
157 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/06/17Import · Class 1 | AMG 133 · No verified English nameJXSL2500096 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/17Import · Class 1 | AMG 133 · No verified English nameJXSL2500095 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/17Import · Class 1 | AMG 133 · No verified English nameJXSL2500094 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/17Import · Class 1 | AMG 133 · No verified English nameJXSL2500093 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/17Import · Class 1 | AMG 133 · No verified English nameJXSL2500092 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/17Import · Class 1 | AMG 133 · No verified English nameJXSL2500091 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/17Import · Class 1 | AZD6621 · No verified English nameJXSL2500090 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd |
| 2025/06/17Import · Class 1 | BI 907828片 · No verified English nameJXHL2500147 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2025/06/17Import · Class 1 | BI 907828片 · No verified English nameJXHL2500146 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2025/06/17Import · Class 1 | BI 907828片 · No verified English nameJXHL2500145 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2025/06/17Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2502162 | Wuhan Yi Bo Yuan Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2025/06/17Generic · Class 3 | Vincriscristine Sulfate InjectionCYHS2502160 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2025/06/17Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2502158 | Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized |
| 2025/06/17Generic · Class 3 | 小儿复方氨基酸注射液(19AA-I) · No verified English nameCYHS2502157 | Ran Dian (Nanjing) Biopharmaceuticals Technology Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
| 2025/06/17Generic · Class 3 | Gabapentin Oral SolutionCYHS2502156 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2025/06/17Generic · Class 3 | Acetylcysteine TabletsCYHS2502155 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/06/17Generic · Class 3 | 盐酸精氨酸注射液 · No verified English nameCYHS2502154 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/06/17Generic · Class 3 | Amisulpride Oral SolutionCYHS2502146 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/06/17Generic · Class 3 | Ferrous Succinate TabletsCYHS2502145 | Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized |
| 2025/06/17Generic · Class 3 | 甲磺酸酚妥拉明滴眼液 · No verified English nameCYHL2500114 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized |
| 2025/06/17New drug · Class 1.1 | 通窍静眩颗粒 · No verified English nameCXZL2500040 | Jiu Hua Hua Yuan Pharma Co., Ltd. romanized |
| 2025/06/17New drug · Class 3.3 | 德谷门冬双胰岛素注射液 · No verified English nameCXSS2500066 | Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized |
| 2025/06/17New drug · Class 3.3 | 德谷门冬双胰岛素注射液 · No verified English nameCXSS2500065 | Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized |
| 2025/06/17New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2500495 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/06/17New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2500494 | Beijing Zai Sheng Bio Technology Research Institute Co., Ltd. romanized |
| 2025/06/17New drug · Class 2.2 | 怡培生长激素注射液 · No verified English nameCXSL2500493 | Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized |
| 2025/06/17New drug · Class 1 | 脐带间充质干细胞注射液 · No verified English nameCXSL2500492 | Zhong Ke Ju Yan (Beijing) Bio Technology Co., Ltd. romanized |
| 2025/06/17New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2500491 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/06/17New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2500490 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2025/06/17New drug · Class 1 | SY-005注射液 · No verified English nameCXSL2500489 | Suzhou Ya Bao Drug Research and Development Co., Ltd. romanized |
127 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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