YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 370 drug applications between 29 August 2024 and 4 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 114, covering 84 drug names.
2024/08/29 – 2024/09/04
- New acceptances this week
- 370
- Drugs with new generic filings (by drug name, de-duplicated)
- 84
- 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
370filings, 114 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 170 |
| Generic | 114 |
| New drug | 64 |
| Import | 14 |
| Import re-registration | 5 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 246 |
| TCM | 70 |
| Therapeutic biologic | 45 |
| Prophylactic biologic | 9 |
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
84 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Rivaroxaban Tablets | 4 | 1 | 3 |
| 2 | 维生素B6注射液 · No verified English name | 3 | 3 | 10 |
| 3 | Bumetanide Injection | 3 | 2 | 13 |
| 4 | Dapoxetine Hydrochloride Tablets | 3 | 2 | 20 |
| 5 | Tadalafil Tablets | 3 | 1 | 23 |
| 6 | Gadobutrol Injection | 3 | 1 | 8 |
| 7 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English name | 2 | 2 | 7 |
| 8 | Formoterol Fumarate Inhalation Solution | 2 | 2 | 5 |
| 9 | 氯化钙注射液 · No verified English name | 2 | 2 | 6 |
| 10 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
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
231 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 11 | 11 | 0 |
| 2 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Jilin Xin Wan Lian Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 4 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 5 | Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 4 |
| 6 | Qingdao Dong Hai Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Janssen-Cilag International NV | 4 | 2 | 0 |
| 8 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized | 4 | 1 | 4 |
| 9 | Jiangsu En Hua Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Anhui Xin Zhi Yuan Pharmaceuticals Co., Ltd. romanized | 3 | 3 | 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
112 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/04Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSS2400071 | Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2024/09/04Import · Class 1 | BI 765179 注射用粉末 · No verified English nameJXSL2400161 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2024/09/04Import · Class 1 | AZD8630 · No verified English nameJXSL2400160 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/04Import · Class 1 | AZD8630 · No verified English nameJXSL2400159 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/04Import · Class 1 | AZD8630 · No verified English nameJXSL2400158 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/04Import · Class 1 | Lunsekimig注射液 · No verified English nameJXSL2400157 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2024/09/04Import · Class 2.4 | Atogepant Tablets · No verified English nameJXHL2400215 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/09/04Import · Class 1 | AZD5004薄膜包衣片 · No verified English nameJXHL2400214 | Eccogene Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/04Import · Class 1 | AZD5004薄膜包衣片 · No verified English nameJXHL2400213 | Eccogene Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/04Import · Class 1 | AZD5004薄膜包衣片 · No verified English nameJXHL2400212 | Eccogene Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/04Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2402911 | Wu Hu Dao Run Pharma Co., Ltd. romanized |
| 2024/09/04Generic · Class 3 | Epalrestat TabletsCYHS2402910 | Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2024/09/04Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2402903 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/09/04Generic · Class 3 | Procaterol Hydrochloride GranulesCYHS2402900 | Shijiazhuang Rong Wu Di Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Chang Jiang Pharma Co., Ltd. romanized |
| 2024/09/04Generic · Class 3 | Procaterol Hydrochloride GranulesCYHS2402899 | Shijiazhuang Rong Wu Di Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Chang Jiang Pharma Co., Ltd. romanized |
| 2024/09/04Generic · Class 3 | Bumetanide InjectionCYHS2402897 | Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized |
| 2024/09/04Generic · Class 3 | Clonidine hydrochloride extended-release tabletsCYHS2402894 | Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized |
| 2024/09/04New drug · Class 1 | 注射用VRT106 · No verified English nameCXSL2400590 | Guangzhou Wei Rong Te Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/04New drug · Class 1 | 注射用BB-1712 · No verified English nameCXSL2400589 | Bai Li Si Kang Biopharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2024/09/04New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2400588 | Jian Da Biopharmaceuticals (Nanjing) Co., Ltd. romanized |
| 2024/09/04New drug · Class 1.1 | 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2400587 | Ji Nuo Wei (Hebei) Bio Technology Co., Ltd. romanized; Beijing Ji Nuo Wei Bio Technology Co., Ltd. romanized; Ji Nuo Wei (Lang Fang Lin Kong Zi Mao Qu) Bio Zhi Pin Co., Ltd. romanized |
| 2024/09/04New drug · Class 1 | ABSK043片 · No verified English nameCXHL2400908 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/04New drug · Class 1 | ABSK043片 · No verified English nameCXHL2400907 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/04New drug · Class 1 | ND-003片 · No verified English nameCXHL2400906 | Shenzhen Shi Xin Yue Bio Technology Co., Ltd. romanized; Shenzhen Shi Xiao Fen Zi Xin Yao Innovation Center Co., Ltd. romanized |
| 2024/09/04New drug · Class 1 | ND-003片 · No verified English nameCXHL2400905 | Shenzhen Shi Xin Yue Bio Technology Co., Ltd. romanized; Shenzhen Shi Xiao Fen Zi Xin Yao Innovation Center Co., Ltd. romanized |
| 2024/09/04New drug · Class 1 | HY-072808软膏 · No verified English nameCXHL2400904 | Hefei En Rui Te Pharma Co., Ltd. romanized; Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized |
| 2024/09/04New drug · Class 1 | HY-072808软膏 · No verified English nameCXHL2400903 | Hefei En Rui Te Pharma Co., Ltd. romanized; Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized |
| 2024/09/04New drug · Class 2.3 | HQ2304胶囊 · No verified English nameCXHL2400902 | Bai Cheng Pharmaceuticals (Zhuhai Heng Qin) Co., Ltd. romanized |
| 2024/09/04New drug · Class 2.3 | HQ2304胶囊 · No verified English nameCXHL2400901 | Bai Cheng Pharmaceuticals (Zhuhai Heng Qin) Co., Ltd. romanized |
| 2024/09/04New drug · Class 1 | 莫米司特片 · No verified English nameCXHL2400900 | Gan Zhou He Mei Pharma Co., Ltd. romanized |
82 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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