YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 527 drug applications between 21 December 2024 and 27 December 2024 (data as of 14 November 2026 06:00). Of these, generic applications numbered 169, covering 114 drug names.
2024/12/21 – 2024/12/27
- New acceptances this week
- 527
- Drugs with new generic filings (by drug name, de-duplicated)
- 114
- Accepted this week, now under review
- 9
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
527filings, 169 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 216 |
| Generic | 169 |
| New drug | 96 |
| Import | 29 |
| Unspecified | 11 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 380 |
| TCM | 79 |
| Therapeutic biologic | 65 |
| Biologic | 2 |
| Prophylactic biologic | 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
114 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Safinamide Methansulfonate Tablets | 8 | 5 | 20 |
| 2 | Lactulose Oral Solution | 6 | 3 | 34 |
| 3 | Vonoprazan Fumarate Tablets | 4 | 2 | 58 |
| 4 | Roxadustat Capsules | 4 | 2 | 13 |
| 5 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 3 | 3 | 23 |
| 6 | Bumetanide Injection | 3 | 2 | 13 |
| 7 | Minoxidil Liniment | 3 | 2 | 52 |
| 8 | Tadalafil Tablets | 3 | 1 | 23 |
| 9 | Lidocaine and Prilocaine Cream | 3 | 1 | 24 |
| 10 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
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
318 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 8 | 5 | 0 |
| 2 | Shandong Qidu Pharmaceutical Co., Ltd. | 8 | 3 | 0 |
| 3 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 6 | 4 | 2 |
| 5 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 7 | Nei Menggu Da Tang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Pfizer Inc. | 5 | 3 | 0 |
| 9 | Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized | 5 | 3 | 1 |
| 10 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | 5 | 2 | 1 |
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
187 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/27Import · Class 2.2 | 注射用德曲妥珠单抗 · No verified English nameJXSL2400255 | Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2024/12/27Import · Class 1 | MEDI5752 · No verified English nameJXSL2400254 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/12/27Import · Class 3.1 | 尘螨变应原舌下片 · No verified English nameJXSL2400253 | ALK-Abelló A/S |
| 2024/12/27Import · Class 1 | HRO761 · No verified English nameJXHL2400305 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/12/27Import · Class 1 | HRO761 · No verified English nameJXHL2400304 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/12/27Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2404589 | Chengdu Yao Yi Li Kang Pharmaceuticals Technology Co., Ltd. romanized; Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanized |
| 2024/12/27Generic · Class 3 | 托吡酯口服溶液 · No verified English nameCYHS2404585 | Hangzhou He Kang Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2024/12/27Generic · Class 3 | Bumetanide InjectionCYHS2404578 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2024/12/27Generic · Class 3 | Bumetanide InjectionCYHS2404577 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2024/12/27Generic · Class 3 | Minoxidil LinimentCYHS2404576 | Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized |
| 2024/12/27Generic · Class 3 | Propafenone Hydrochloride InjectionCYHS2404572 | Hebei Qiao Zhou Pharmaceuticals Technology Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2024/12/27Generic · Class 3 | 复方醋酸钠林格注射液 · No verified English nameCYHS2404568 | Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized |
| 2024/12/27Generic · Class 3 | Paracetamol TabletsCYHS2404564 | YaoPharma Co., Ltd. |
| 2024/12/27Generic · Class 3 | Aripiprazole Orally Disintegrating tabletsCYHS2404560 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2024/12/27Generic · Class 3 | Aripiprazole Orally Disintegrating tabletsCYHS2404559 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2024/12/27Generic · Class 3 | Benzbromarone TabletsCYHS2404558 | Beijing Foyou Pharma CO.,LTD |
| 2024/12/27Generic · Class 3 | Lidocaine and Tetracaine CreamCYHL2400278 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2024/12/27Generic · Class 3 | Ramelteon TabletsCYHL2400276 | Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized |
| 2024/12/27New drug · Class 1 | HS-20117注射液 · No verified English nameCXSL2400917 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2024/12/27New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2400916 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2024/12/27New drug · Class 1 | 注射用SHR-A2102 · No verified English nameCXSL2400915 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/12/27New drug · Class 1 | BBM-A101注射液 · No verified English nameCXSL2400914 | Xin Zhong Pharmaceuticals Technology (Beijing) Co., Ltd. romanized; Shanghai Xin Zhi Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Mian Yi Bio Technology Co., Ltd. romanized |
| 2024/12/27New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2400913 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/12/27New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2400912 | Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized; Chuang Zhi Xing (Guangzhou) Bio Technology Co., Ltd. romanized |
| 2024/12/27New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2400911 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/12/27New drug · Class 3.4 | 注射用重组改构人肿瘤坏死因子 · No verified English nameCXSL2400910 | Guangdong Tai He Bio Pharma Co., Ltd. romanized |
| 2024/12/27New drug · Class 1 | SNA02-48注射液 · No verified English nameCXSL2400909 | Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized; Xing Meng Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2024/12/27New drug · Class 2.2 | FL-0011 · No verified English nameCXHL2401468 | Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/27New drug · Class 2.2 | FL-0011 · No verified English nameCXHL2401467 | Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/27New drug · Class 2.2 | KLA514-2片 · No verified English nameCXHL2401466 | Sichuan Kelun Pharmaceutical Co., Ltd. |
157 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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