YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 290 drug applications between 15 August 2024 and 21 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 68 drug names.
2024/08/15 – 2024/08/21
- New acceptances this week
- 290
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- Accepted this week, now under review
- 5
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
290filings, 93 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 129 |
| Generic | 93 |
| New drug | 43 |
| Unspecified | 13 |
| Import | 11 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 189 |
| TCM | 58 |
| Therapeutic biologic | 33 |
| Biologic | 8 |
| Prophylactic biologic | 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
68 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 甲磺酸多沙唑嗪片 · No verified English name | 3 | 1 | 0 |
| 2 | Nicardipine Hydrochloride Injection | 3 | 1 | 13 |
| 3 | Epalrestat Tablets | 2 | 2 | 1 |
| 4 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 2 | 2 | 9 |
| 5 | Sodium Bicarbonate Injection | 2 | 2 | 10 |
| 6 | Lactulose Oral Solution | 2 | 1 | 34 |
| 7 | 依伏卡塞片 · No verified English name | 2 | 1 | 9 |
| 8 | Sodium Picosulfate Oral Solution | 2 | 1 | 0 |
| 9 | Sodium Tetradecyl Sulphate Injection | 2 | 1 | 0 |
| 10 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
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
188 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hunan San Xue Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 2 | Novartis Pharma AG | 6 | 2 | 0 |
| 3 | Novo Nordisk A/S | 5 | 1 | 0 |
| 4 | Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | Guangxi Chan Fang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Janssen Research & Development LLC | 4 | 2 | 0 |
| 7 | Hubei Mei Lin Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Jiangsu Shen Hua Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Guizhou Xin Bang Pharmaceutical Co., Ltd. romanized | 3 | 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
93 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/08/21Generic · Class 3 | 枸橼酸西地那非口溶膜 · No verified English nameCYHS2402732 | Zhejiang Le Pu Pharmaceutical Co., Ltd. romanized |
| 2024/08/21Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2402725 | Anhui Pioneer Pharmaceutical Co., Ltd; Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized |
| 2024/08/21Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2402724 | Anhui Pioneer Pharmaceutical Co., Ltd; Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized |
| 2024/08/21Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2402722 | Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized; Xi Nan Pharma Co., Ltd. romanized |
| 2024/08/21Generic · Class 3 | Amifostine For InjectionCYHS2402719 | Sichuan Shang Shan Liu Jing Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2024/08/21Generic · Class 3 | Fat-Soluble Vitamin Injection(Ⅱ)CYHS2402718 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/08/21Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2402716 | Nanjing Hai Jing Pharma Co., Ltd. romanized |
| 2024/08/21Generic · Class 3 | Sodium Picosulfate Oral SolutionCYHL2400171 | Nanjing Si Tai Er Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/21Generic · Class 3 | Sodium Picosulfate Oral SolutionCYHL2400170 | Nanjing Si Tai Er Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/21New drug · Class 1 | GZL-016注射液 · No verified English nameCXSL2400556 | Guangzhou Lai En Biopharmaceuticals Co., Ltd. romanized |
| 2024/08/21New drug · Class 2.4 | 奥布替尼片 · No verified English nameCXHS2400078 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2024/08/21New drug · Class 1 | 注射用RAB001 · No verified English nameCXHL2400853 | Zhong Shan Lai Bo Rui Chen Biopharmaceuticals Co., Ltd. romanized |
| 2024/08/21New drug · Class 2.2 | BCM684口崩片 · No verified English nameCXHL2400852 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized |
| 2024/08/20Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2402712 | Shandong Lukang Pharmaceutical Co.,Ltd. |
| 2024/08/20Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2402711 | Shandong Lukang Pharmaceutical Co.,Ltd. |
| 2024/08/20Generic · Class 3 | Potassium Chloride InjectionCYHS2402710 | Shijiazhuang Xing Ze Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2024/08/20Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2402706 | Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized |
| 2024/08/20Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2402705 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2024/08/20Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2402704 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2024/08/20Generic · Class 3 | 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2402699 | Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2024/08/20Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2402696 | Xu Bi Di Pharma (Hebei) Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2024/08/20Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2402692 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2024/08/20Generic · Class 3 | Cariprazine hydrochloride CapsulesCYHL2400169 | Chengdu Ao Bang Pharma Co., Ltd. romanized |
| 2024/08/20Generic · Class 3 | Cariprazine hydrochloride CapsulesCYHL2400168 | Chengdu Ao Bang Pharma Co., Ltd. romanized |
| 2024/08/20New drug · Class 1 | 注射用芦康沙妥珠单抗 · No verified English nameCXSS2400087 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2024/08/20New drug · Class 3.4 | 帕尼单抗注射液 · No verified English nameCXSS2400086 | Qilu Pharmaceutical Co., Ltd. |
| 2024/08/20New drug · Class 1 | CVL006 注射液 · No verified English nameCXSL2400555 | Fu Kang (Shanghai) Health Technology Co., Ltd. romanized; Zhejiang Fu Kang Pharmaceutical Co., Ltd. romanized |
| 2024/08/20New drug · Class 1 | IBI115 · No verified English nameCXSL2400554 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/08/20New drug · Class 2.4 | 甲磺酸阿美替尼片 · No verified English nameCXHS2400077 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2024/08/20New drug · Class 1 | 洛布替尼片 · No verified English nameCXHL2400851 | Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized |
63 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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