YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 493 drug applications between 23 December 2024 and 29 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 169, covering 119 drug names.
2024/12/23 – 2024/12/29
- New acceptances this week
- 493
- Drugs with new generic filings (by drug name, de-duplicated)
- 119
- Accepted this week, now under review
- 12
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
493filings, 169 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 184 |
| Generic | 169 |
| New drug | 107 |
| Import | 22 |
| Import re-registration | 6 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 359 |
| TCM | 73 |
| Therapeutic biologic | 60 |
| 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
119 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lactulose Oral Solution | 6 | 3 | 34 |
| 2 | Safinamide Methansulfonate Tablets | 5 | 3 | 20 |
| 3 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 4 | Roxadustat Capsules | 4 | 2 | 17 |
| 5 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 3 | 3 | 23 |
| 6 | Cimetidine Injection | 3 | 3 | 5 |
| 7 | Bumetanide Injection | 3 | 2 | 13 |
| 8 | 甲氧氯普胺片 · No verified English name | 3 | 2 | 3 |
| 9 | Minoxidil Liniment | 3 | 2 | 52 |
| 10 | Lidocaine and Prilocaine Cream | 3 | 1 | 24 |
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
301 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Qidu Pharmaceutical Co., Ltd. | 9 | 4 | 1 |
| 2 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | AstraZeneca AB | 8 | 5 | 0 |
| 4 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 7 | 5 | 3 |
| 5 | Nei Menggu Da Tang Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 7 | Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized | 5 | 3 | 1 |
| 10 | Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized | 4 | 4 | 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
210 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/28Import · Class 1 | PF-08046054 (注射用冻干粉针) · No verified English nameJXSL2400256 | Seagen Inc.; Pfizer Investment CO. Ltd. |
| 2024/12/28Import · Class 2.4 | Upadacitinib Sustained-release TabletsJXHS2400119 | AbbVie Deutschland GmbH & Co.KG; AbbVie Ireland NL B.V. |
| 2024/12/28Generic · Class 3 | Atropine Sulfate InjectionCYHS2404615 | Yan Tai Wan Run Pharma Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2024/12/28Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2404614 | Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized |
| 2024/12/28Generic · Class 3 | 盐酸多沙普仑注射液 · No verified English nameCYHS2404612 | Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2024/12/28Generic · Class 3 | 盐酸多沙普仑注射液 · No verified English nameCYHS2404611 | Hubei Jian Cheng Bo Tai Pharmaceuticals Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized |
| 2024/12/28Generic · Class 3 | Clonazepam InjectionCYHS2404609 | Guo Yao Group Gong Ye Co., Ltd. Lang Fang Branch romanized |
| 2024/12/28Generic · Class 3 | 甲氧氯普胺片 · No verified English nameCYHS2404607 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/12/28Generic · Class 3 | Cimetidine InjectionCYHS2404606 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/12/28Generic · Class 3 | Cimetidine InjectionCYHS2404605 | Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2024/12/28Generic · Class 3 | 维生素B?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2404604 | Guangdong Jun Kang Pharma Co., Ltd. romanized; Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized |
| 2024/12/28Generic · Class 3 | Trimebutine Maleate TabletsCYHS2404603 | Zhejiang AngLiKang Pharmaceutical CO.,LTD.; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/12/28Generic · Class 3 | Trimebutine Maleate TabletsCYHS2404602 | Zhejiang AngLiKang Pharmaceutical CO.,LTD.; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/12/28Generic · Class 3 | Compound Paracetamol and Vitamin C Effervescent TabletsCYHS2404600 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2024/12/28Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2404599 | Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2024/12/28Generic · Class 3 | 阿瑞匹坦注射液 · No verified English nameCYHS2404598 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2024/12/28Generic · Class 3 | Aminophylline InjectionCYHS2404595 | Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized |
| 2024/12/28Generic · Class 3 | Aminophylline InjectionCYHS2404594 | Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized |
| 2024/12/28Generic · Class 3 | Lidocaine Hydrochloride Ophthalmic GelCYHL2400281 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2024/12/28Generic · Class 3 | Rupatadine Fumarate Oral SolutionCYHL2400280 | Guangzhou Shi Tong Hui Pharma Co., Ltd. romanized |
| 2024/12/28Generic · Class 3 | Minocycline Hydrochloride For InjectionCYHL2400279 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized |
| 2024/12/28New drug · Class 3.1 | 半夏白术天麻汤颗粒 · No verified English nameCXZS2400040 | Anhui Hua Run Jin Chan Pharma Co., Ltd. romanized |
| 2024/12/28New drug · Class 1 | XP-001-V2 · No verified English nameCXSL2400922 | Shanghai Xin Pu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/28New drug · Class 1 | 注射用MHB036C · No verified English nameCXSL2400921 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2024/12/28New drug · Class 1 | 注射用MHB039A · No verified English nameCXSL2400920 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2024/12/28New drug · Class 1 | CD-001注射液 · No verified English nameCXSL2400919 | Cheng Dian (Suzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2024/12/28New drug · Class 1 | 注射用DB-1419 · No verified English nameCXSL2400918 | Ying En Bio Technology (Shanghai) Co., Ltd. romanized |
| 2024/12/28New drug · Class 2.4 | 依达拉奉右莰醇舌下片 · No verified English nameCXHL2401490 | Xian Sheng Pharma Co., Ltd. romanized |
| 2024/12/28New drug · Class 1 | TLX-83胶囊 · No verified English nameCXHL2401489 | Zhejiang University romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhong Ke Zhong Shan Drug Innovation Research Institute romanized; Yan Tai Xin Yao Chuang Zhi Shandong Sheng Laboratory romanized |
| 2024/12/28New drug · Class 1 | TLX-83胶囊 · No verified English nameCXHL2401488 | Zhejiang University romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhong Ke Zhong Shan Drug Innovation Research Institute romanized; Yan Tai Xin Yao Chuang Zhi Shandong Sheng Laboratory romanized |
180 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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