YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 386 drug applications between 27 November 2024 and 3 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 107, covering 86 drug names.
2024/11/27 – 2024/12/03
- New acceptances this week
- 386
- Drugs with new generic filings (by drug name, de-duplicated)
- 86
- Accepted this week, now under review
- 11
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
386filings, 107 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 194 |
| Generic | 107 |
| New drug | 52 |
| Import | 15 |
| Import re-registration | 10 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 260 |
| TCM | 77 |
| Therapeutic biologic | 43 |
| Biologic | 5 |
| 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
86 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 5 | 3 | 60 |
| 2 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 3 | 氧 · No verified English name | 2 | 2 | 15 |
| 4 | Isavuconazonium Sulfate for Injection | 2 | 2 | 15 |
| 5 | Clopidogrel Hydrogen Sulphate Tablets | 2 | 2 | 6 |
| 6 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 7 | Quetiapine Fumarate Extended-release Tablets | 2 | 1 | 0 |
| 8 | Brexpiprazole Tablets | 2 | 1 | 31 |
| 9 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 10 | Lysine Acetylsalicylate For Injection | 2 | 1 | 8 |
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
240 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 14 | 4 | 0 |
| 2 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 9 | 9 | 0 |
| 3 | The Wellcome Foundation Limited | 7 | 2 | 0 |
| 4 | Fresenius Kabi Deutschland GmbH | 6 | 1 | 0 |
| 5 | Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 5 | 5 | 5 |
| 6 | Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 5 | 3 | 0 |
| 8 | Hua Zhong Pharma Co., Ltd. romanized | 5 | 2 | 3 |
| 9 | Novo Nordisk A/S | 5 | 1 | 0 |
| 10 | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 5 | 1 | 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
100 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/03Import · Class 1 | PIT565 · No verified English nameJXSL2400232 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/12/03Generic · Class 3 | Cetylpyridinium Chloride Buccal TabletsCYHS2404168 | Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized |
| 2024/12/03Generic · Class 3 | Phloroglucinol Orally Disintegrating TabletsCYHS2404166 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/12/03Generic · Class 3 | Olmesartan Medoxomil Orally Disintegrating TabletsCYHS2404165 | Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized |
| 2024/12/03Generic · Class 3 | Propafenone Hydrochloride InjectionCYHS2404164 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2024/12/03Generic · Class 3 | Propafenone Hydrochloride InjectionCYHS2404163 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2024/12/03Generic · Class 3 | Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHS2404162 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2024/12/03Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2404161 | Shanxi Jiu Kang Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2024/12/03Generic · Class 3 | Epalrestat TabletsCYHS2404160 | Hainan Sai Li Ke Pharma Co., Ltd. romanized |
| 2024/12/03Generic · Class 3 | Lysine Acetylsalicylate For InjectionCYHS2404158 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2024/12/03Generic · Class 3 | Lysine Acetylsalicylate For InjectionCYHS2404156 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2024/12/03Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2404145 | Shandong Xu Lie Bio Technology Co., Ltd. romanized; Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/12/03Generic · Class 3 | Famotidine InjectionCYHS2404140 | Guangdong Jun Kang Pharma Co., Ltd. romanized; Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized |
| 2024/12/03Generic · Class 3 | Aripiprazole Oral SolutionCYHS2404139 | Zhejiang Zhe Bei Pharma Co., Ltd. romanized |
| 2024/12/03Generic · Class 3 | 雷芬那辛吸入溶液 · No verified English nameCYHL2400239 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2024/12/03New drug · Class 1.1 | 小儿热平颗粒 · No verified English nameCXZL2400083 | Jiu Hua Hua Yuan Pharma Co., Ltd. romanized |
| 2024/12/03New drug · Class 1.1 | 小儿热平颗粒 · No verified English nameCXZL2400082 | Jiu Hua Hua Yuan Pharma Co., Ltd. romanized |
| 2024/12/03New drug · Class 1.1 | 补髓益智颗粒 · No verified English nameCXZL2400081 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2024/12/03New drug · Class 3.2 | 皮下注射人免疫球蛋白 · No verified English nameCXSS2400133 | Chengdu Rong Sheng Pharma Co., Ltd. romanized |
| 2024/12/03New drug · Class 3.3 | 利拉鲁肽注射液 · No verified English nameCXSS2400132 | Chongqing Chen An Biopharmaceutical Co., Ltd. romanized |
| 2024/12/03New drug · Class 1 | 注射用重组病毒巨噬细胞炎性蛋白 · No verified English nameCXSL2400814 | Guangzhou Hong Run Bio Technology Co., Ltd. romanized |
| 2024/12/03New drug · Class 1 | IBI3017 · No verified English nameCXSL2400813 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/12/03New drug · Class 1 | DC50292A片 · No verified English nameCXHL2401311 | Beijing Shuang He Run Chuang Technology Co., Ltd. romanized |
| 2024/12/03New drug · Class 1 | DC50292A片 · No verified English nameCXHL2401310 | Beijing Shuang He Run Chuang Technology Co., Ltd. romanized |
| 2024/12/03New drug · Class 1 | AL2846胶囊 · No verified English nameCXHL2401309 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/12/03New drug · Class 1 | QB0208-1胶囊 · No verified English nameCXHL2401308 | Beijing Qing Bo Hui Neng Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/03New drug · Class 1 | QB0208-1胶囊 · No verified English nameCXHL2401307 | Beijing Qing Bo Hui Neng Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/03New drug · Class 1 | LT-002-158片 · No verified English nameCXHL2401306 | Ling Tai Biopharmaceuticals (Shao Xing) Co., Ltd. romanized |
| 2024/12/03New drug · Class 1 | LT-002-158片 · No verified English nameCXHL2401305 | Ling Tai Biopharmaceuticals (Shao Xing) Co., Ltd. romanized |
| 2024/12/02Generic · Class 3 | Bumetanide InjectionCYHS2404137 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
70 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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