YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 528 drug applications between 26 December 2024 and 1 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 167, covering 122 drug names.
2024/12/26 – 2025/01/01
- New acceptances this week
- 528
- Drugs with new generic filings (by drug name, de-duplicated)
- 122
- Accepted this week, now under review
- 16
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
528filings, 167 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 192 |
| Generic | 167 |
| New drug | 121 |
| Import | 27 |
| Unspecified | 16 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 385 |
| TCM | 76 |
| Therapeutic biologic | 65 |
| Biologic | 1 |
| 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
122 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Safinamide Methansulfonate Tablets | 7 | 4 | 20 |
| 2 | Lactulose Oral Solution | 4 | 2 | 34 |
| 3 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 4 | 甲氧氯普胺片 · No verified English name | 3 | 2 | 3 |
| 5 | Minoxidil Liniment | 3 | 2 | 52 |
| 6 | Paliperidone Palmitate Injection | 3 | 1 | 8 |
| 7 | Mirogabalin Besilate Tablets | 3 | 1 | 61 |
| 8 | Ibrutinib Capsules | 2 | 2 | 9 |
| 9 | Formoterol Fumarate Inhalation Solution | 2 | 2 | 5 |
| 10 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 2 | 23 |
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
324 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 11 | 11 | 0 |
| 2 | AstraZeneca AB | 8 | 5 | 0 |
| 3 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 7 | 5 | 3 |
| 4 | Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized | 7 | 3 | 0 |
| 5 | Heng Chang (Guangzhou) Xin Yao Research 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 | Chengdu Easton Biopharmaceuticals Co.,Ltd. | 5 | 2 | 3 |
| 10 | Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | 5 | 2 | 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
208 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/01Import · Class 1 | 德莫奇单抗注射液 · No verified English nameJXSS2400114 | GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Limited trading as Glaxo Wellcome Operations; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2025/01/01Import · Class 1 | 德莫奇单抗注射液 · No verified English nameJXSS2400113 | GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Limited trading as Glaxo Wellcome Operations; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2025/01/01Import · Class 2.4 | 放射性药物镓[68Ga]oxodotreotide注射液配制用药盒 · No verified English nameJXHL2400308 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/01/01Import · Class 2.4 | 镥[177Lu]oxodotreotide注射液 · No verified English nameJXHL2400307 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/01/01Generic · Class 3 | 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2404663 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/01/01Generic · Class 3 | Metronidazole Vaginal GelCYHS2404662 | Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized |
| 2025/01/01Generic · Class 3 | Minoxidil LinimentCYHS2404653 | Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized; Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized |
| 2025/01/01Generic · Class 3 | Minoxidil LinimentCYHS2404652 | Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized; Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized |
| 2025/01/01Generic · Class 3 | Ibuprofen Soft CapsulesCYHS2404651 | Ren Fu Pu Ke Pharma (Hainan) Co., Ltd. romanized; Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized |
| 2025/01/01Generic · Class 3 | 氢溴酸加兰他敏口崩片 · No verified English nameCYHS2404649 | Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized |
| 2025/01/01Generic · Class 3 | 氢溴酸加兰他敏口崩片 · No verified English nameCYHS2404648 | Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized |
| 2025/01/01Generic · Class 3 | 达普司他片 · No verified English nameCYHL2400287 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2025/01/01Generic · Class 3 | 达普司他片 · No verified English nameCYHL2400286 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2025/01/01Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHL2400285 | Tianjin Hong Ri Pharma Co., Ltd. romanized |
| 2025/01/01New drug · Class 3.1 | 大建中膏 · No verified English nameCXZS2400041 | Hua Run San Jiu (Ya An) Pharma Co., Ltd. romanized |
| 2025/01/01New drug · Class 1.1 | 金桔余甘含片 · No verified English nameCXZL2400101 | Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized |
| 2025/01/01New drug · Class 2.4 | 注射用重组A型肉毒毒素 · No verified English nameCXSS2400144 | Chongqing Yu Yan Pharmaceutical Co., Ltd. romanized |
| 2025/01/01New drug · Class 1 | GFS202A注射液 · No verified English nameCXSL2400937 | Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/01/01New drug · Class 1 | IBI363 · No verified English nameCXSL2400936 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/01/01New drug · Class 1 | IBI363 · No verified English nameCXSL2400935 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/01/01New drug · Class 1 | VUM03注射液 · No verified English nameCXSL2400934 | Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized |
| 2025/01/01New drug · Class 1 | DNTH103注射液 · No verified English nameCXSL2400933 | Yuan Yi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2025/01/01New drug · Class 1 | RDc001片 · No verified English nameCXHL2401511 | Henan Sheng Rui Da Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/01New drug · Class 1 | RDc001片 · No verified English nameCXHL2401510 | Henan Sheng Rui Da Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/01New drug · Class 1 | RDc001片 · No verified English nameCXHL2401509 | Henan Sheng Rui Da Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/01New drug · Class 1 | HS-10380片 · No verified English nameCXHL2401508 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/01New drug · Class 1 | K-13片 · No verified English nameCXHL2401507 | Shanghai Yi Feng Bio Technology Co., Ltd. romanized |
| 2025/01/01New drug · Class 1 | K-13片 · No verified English nameCXHL2401506 | Shanghai Yi Feng Bio Technology Co., Ltd. romanized |
| 2025/01/01New drug · Class 1 | K-13片 · No verified English nameCXHL2401505 | Shanghai Yi Feng Bio Technology Co., Ltd. romanized |
| 2025/01/01New drug · Class 1 | RAG-1C眼内注射液 · No verified English nameCXHL2401504 | Zhong Mei Rui Kang He Suan Technology (Nan Tong) Research Institute Co., Ltd. romanized |
178 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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