YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 406 drug applications between 5 December 2024 and 11 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 121, covering 76 drug names.
2024/12/05 – 2024/12/11
- New acceptances this week
- 406
- Drugs with new generic filings (by drug name, de-duplicated)
- 76
- Accepted this week, now under review
- 7
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
406filings, 121 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 178 |
| Generic | 121 |
| New drug | 73 |
| Import | 17 |
| Unspecified | 11 |
| Import re-registration | 5 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 261 |
| TCM | 71 |
| Therapeutic biologic | 57 |
| Biologic | 8 |
| Prophylactic biologic | 7 |
| In vitro diagnostic reagent | 2 |
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
76 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 14 | 7 | 60 |
| 2 | Lactulose Oral Solution | 5 | 1 | 34 |
| 3 | Ambroxol Hydrochloride Oral Solution | 4 | 1 | 46 |
| 4 | Isavuconazonium Sulfate for Injection | 3 | 3 | 15 |
| 5 | Sodium Bicarbonate Injection | 3 | 2 | 10 |
| 6 | Oxcarbazepine Extended-release Tablets | 3 | 1 | 0 |
| 7 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 8 | Levocarnitine Oral Solution | 2 | 2 | 9 |
| 9 | Mupirocin Ointment | 2 | 2 | 30 |
| 10 | Progesterone Injection | 2 | 2 | 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
248 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangxi Qing Feng Pharma Co., Ltd. romanized | 7 | 6 | 0 |
| 2 | Ren He Yi Kang Group Co., Ltd. romanized | 7 | 3 | 2 |
| 3 | Ya Bao Pharma Group Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Novo Nordisk A/S | 5 | 3 | 0 |
| 6 | Shaanxi Xing Bang Pharma Co., Ltd. romanized | 5 | 1 | 5 |
| 7 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Tong Hua Zheng Yuan Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 4 | 3 | 1 |
| 10 | Hainan Sai Li Ke Pharma Co., Ltd. romanized | 4 | 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
119 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/11Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2404303 | Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2024/12/11Generic · Class 3 | Atropine Sulfate InjectionCYHS2404301 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2024/12/11Generic · Class 3 | Famotidine InjectionCYHS2404291 | Hangzhou Min Sheng Drug Research Institute Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2024/12/11Generic · Class 3 | Potassium Phosphates InjectionCYHS2404290 | Shijiazhuang Rong Wu Di Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2024/12/11Generic · Class 3 | Multiple Electrolyte Additive For InjectionCYHS2404289 | Suzhou Lang Yi Biopharmaceuticals Research Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized |
| 2024/12/11New drug · Class 2.3 | 淫羊藿总黄酮胶囊 · No verified English nameCXZL2400088 | Jiangsu Kang Yuan Yang Guang Pharma Co., Ltd. romanized |
| 2024/12/11New drug · Class 1.1 | 固本消疹颗粒 · No verified English nameCXZL2400087 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2024/12/11New drug · Class 1.2 | 冻干呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2400850 | Suzhou Ai Bo Bio Technology Co., Ltd. romanized; Ai Bo Bio Technology (Shanghai) Co., Ltd. romanized |
| 2024/12/11New drug · Class 1.2 | 冻干呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2400849 | Suzhou Ai Bo Bio Technology Co., Ltd. romanized; Ai Bo Bio Technology (Shanghai) Co., Ltd. romanized |
| 2024/12/11New drug · Class 1.2 | 冻干呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2400848 | Suzhou Ai Bo Bio Technology Co., Ltd. romanized; Ai Bo Bio Technology (Shanghai) Co., Ltd. romanized |
| 2024/12/11New drug · Class 1.2 | 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2400847 | Beijing Ji Nuo Wei Bio Technology Co., Ltd. romanized; Ji Nuo Wei (Hebei) Bio Technology Co., Ltd. romanized; Ji Nuo Wei (Lang Fang Lin Kong Zi Mao Qu) Bio Zhi Pin Co., Ltd. romanized |
| 2024/12/11New drug · Class 2.2 | 人干扰素α2b喷雾剂 · No verified English nameCXSL2400846 | Tianjin Wei Ming Biopharmaceuticals Co., Ltd. romanized |
| 2024/12/11New drug · Class 2.2 | 人干扰素α2b喷雾剂 · No verified English nameCXSL2400845 | Tianjin Wei Ming Biopharmaceuticals Co., Ltd. romanized |
| 2024/12/11New drug · Class 1 | 重组人源化抗Trop2单抗-SN38偶联物 · No verified English nameCXSL2400844 | Shanghai Shi Jian Bio Technology Co., Ltd. romanized |
| 2024/12/11New drug · Class 2.2 | BN021208H · No verified English nameCXHL2401356 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2024/12/11New drug · Class 1 | AP306片 · No verified English nameCXHL2401355 | Shanghai Li Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/11New drug · Class 1 | AP306片 · No verified English nameCXHL2401354 | Shanghai Li Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/11New drug · Class 1 | AP306片 · No verified English nameCXHL2401353 | Shanghai Li Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/11New drug · Class 1 | AP306片 · No verified English nameCXHL2401352 | Shanghai Li Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/11New drug · Class 1 | HS-10561胶囊 · No verified English nameCXHL2401351 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/11New drug · Class 1 | HS-10561胶囊 · No verified English nameCXHL2401350 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/11New drug · Class 1 | HS-10561胶囊 · No verified English nameCXHL2401349 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/11New drug · Class 1 | IN10018片 · No verified English nameCXHL2401348 | Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2024/12/11New drug · Class 1 | IN10018片 · No verified English nameCXHL2401347 | Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2024/12/11New drug · Class 1 | JK0001片 · No verified English nameCXHL2401346 | Shenzhen Jia Ke Bio Technology Co., Ltd. romanized |
| 2024/12/11New drug · Class 1 | JK0001片 · No verified English nameCXHL2401345 | Shenzhen Jia Ke Bio Technology Co., Ltd. romanized |
| 2024/12/11New drug · Class 1 | SBK013片 · No verified English nameCXHL2401344 | Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/10Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2400235 | Merck Sharp & Dohme LLC; MSD R&D(China) Co. Ltd |
| 2024/12/10Generic · Class 3 | Ferrous Succinate TabletsCYHS2404279 | Chi Feng Gu De Pharma Co., Ltd. romanized; Zhejiang Nord Pharmaceutical Co., Ltd |
| 2024/12/10Generic · Class 3 | Ketamine Hydrochloride InjectionCYHS2404278 | Guo Yao Group Gong Ye Co., Ltd. Lang Fang Branch romanized |
89 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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