YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 360 drug applications between 20 December 2023 and 26 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 100, covering 72 drug names.
2023/12/20 – 2023/12/26
- New acceptances this week
- 360
- Drugs with new generic filings (by drug name, de-duplicated)
- 72
- Accepted this week, now under review
- 1
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
360filings, 100 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 163 |
| Generic | 100 |
| New drug | 53 |
| Import | 24 |
| Unspecified | 12 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 249 |
| TCM | 62 |
| Therapeutic biologic | 42 |
| Biologic | 3 |
| Prophylactic biologic | 3 |
| In vitro diagnostic reagent | 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
72 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lactulose Oral Solution | 4 | 3 | 34 |
| 2 | Carboplatin Injection | 4 | 2 | 10 |
| 3 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 4 | Roxadustat Capsules | 3 | 2 | 17 |
| 5 | Ketorolac Tromethamine Injection | 3 | 2 | 4 |
| 6 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 2 | 23 |
| 7 | Ceftazidime And Avibactam Sodium For Injection | 2 | 2 | 12 |
| 8 | Progesterone Sustained-release Vaginal Gel | 2 | 2 | 2 |
| 9 | Folic acid injection | 2 | 1 | 1 |
| 10 | Diquafosol Sodium Eye Drops | 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
217 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized | 14 | 1 | 0 |
| 2 | AstraZeneca AB | 9 | 5 | 0 |
| 3 | Shenyang Hong Yao Group Co., Ltd. romanized | 7 | 6 | 0 |
| 4 | Guizhou Bai Ling Qi Ye Group Pharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 5 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Guangzhou Bai Yun Shan Tian Xin Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 8 | Hainan Xu Wo Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 4 | 3 | 4 |
| 10 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 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
106 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/26Import · Class 2.2 | Benralizumab注射液 · No verified English nameJXSL2300235 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/12/26Import · Class 1 | BI1569912 片 · No verified English nameJXHL2300328 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/12/26Import · Class 1 | BI1569912 片 · No verified English nameJXHL2300327 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/12/26Generic · Class 3 | Multiple Electrolytes and Sodium Acetate InjectionCYHS2303623 | Shandong Ke Lun Pharma Co., Ltd. romanized |
| 2023/12/26Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2303622 | Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized |
| 2023/12/26Generic · Class 3 | 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2303617 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
| 2023/12/26Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2303616 | Jiangsu Ming Sheng Kang Yuan Pharma Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2023/12/26Generic · Class 3 | Remifentanil Hydrochloride for InjectionCYHS2303613 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2023/12/26Generic · Class 3 | Remifentanil Hydrochloride for InjectionCYHS2303612 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2023/12/26Generic · Class 3 | Nefopam Hydrochloride InjectionCYHS2303608 | Anhui Heng Xing Pharmaceutical Co., Ltd. romanized |
| 2023/12/26Generic · Class 3 | Acetylcysteine InjectionCYHS2303606 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
| 2023/12/26Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2303605 | Guangdong Ding Xin Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2023/12/26Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2303601 | Jiangsu Deyuan Pharmaceutical Co.,Ltd. |
| 2023/12/26Generic · Class 3 | 盐酸氨酮戊酸口服溶液用粉末 · No verified English nameCYHL2300157 | Tai Zhou Fu Dan Zhang Jiang Pharma Co., Ltd. romanized |
| 2023/12/26New drug · Class 1.1 | 铁皮石斛咀嚼片 · No verified English nameCXZL2300075 | Hangzhou Dan He Pharmaceuticals Co., Ltd. romanized |
| 2023/12/26New drug · Class 1 | KH801注射液 · No verified English nameCXSL2300890 | Beijing Kang Hong Biopharmaceuticals Co., Ltd. romanized |
| 2023/12/26New drug · Class 1 | HLX6018 · No verified English nameCXSL2300889 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized |
| 2023/12/26New drug · Class 1 | 注射用MK-1200 · No verified English nameCXSL2300888 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2023/12/26New drug · Class 1 | VIC-1911片 · No verified English nameCXHL2301448 | Jie Si Ying Da Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Jie Si Ying Da Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2023/12/26New drug · Class 1 | FHND6091胶囊 · No verified English nameCXHL2301447 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized |
| 2023/12/26New drug · Class 1 | FHND6091胶囊 · No verified English nameCXHL2301446 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized |
| 2023/12/26New drug · Class 1 | GY-1068胶囊 · No verified English nameCXHL2301445 | Shanghai Gui Zhi Yan Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/26New drug · Class 1 | LD09163片 · No verified English nameCXHL2301444 | Shanghai Li Dao Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/26New drug · Class 1 | LD09163片 · No verified English nameCXHL2301443 | Shanghai Li Dao Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/26New drug · Class 1 | 注射用AST2169脂质体 · No verified English nameCXHL2301442 | Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/25Import · Class 1 | AZD9829 · No verified English nameJXSL2300234 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd |
| 2023/12/25Import · Class 1 | Etavopivat · No verified English nameJXHL2300326 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2023/12/25Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2303595 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2023/12/25Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2303594 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/12/25Generic · Class 3 | Folic acid injectionCYHS2303593 | Beijing Bu Lin Bio Technology Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
76 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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