YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 301 drug applications between 14 August 2024 and 20 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 69 drug names.
2024/08/14 – 2024/08/20
- New acceptances this week
- 301
- Drugs with new generic filings (by drug name, de-duplicated)
- 69
- 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
301filings, 96 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 133 |
| Generic | 96 |
| New drug | 48 |
| Import | 13 |
| Unspecified | 9 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 195 |
| TCM | 62 |
| Therapeutic biologic | 37 |
| Prophylactic biologic | 4 |
| Biologic | 3 |
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
69 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 3 | 3 | 9 |
| 2 | Atorvastatin Calcium Tablets | 3 | 2 | 24 |
| 3 | 甲磺酸多沙唑嗪片 · No verified English name | 3 | 1 | 0 |
| 4 | Epalrestat Tablets | 2 | 2 | 1 |
| 5 | Eperisone Hydrochloride Tablets | 2 | 2 | 8 |
| 6 | Sodium Bicarbonate Injection | 2 | 2 | 10 |
| 7 | 依伏卡塞片 · No verified English name | 2 | 1 | 9 |
| 8 | Sodium Tetradecyl Sulphate Injection | 2 | 1 | 0 |
| 9 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 10 | Tropicamide Phenylephrine Eye Drops | 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
192 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novartis Pharma AG | 6 | 2 | 0 |
| 2 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 5 | 3 | 0 |
| 3 | Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 4 | Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | Guangxi Chan Fang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED | 4 | 3 | 0 |
| 7 | Shanghai Shang Yao Di Yi Sheng Hua Pharma Co., Ltd. romanized | 4 | 3 | 2 |
| 8 | Qilu Pharmaceutical Co., Ltd. | 4 | 3 | 1 |
| 9 | Janssen Research & Development LLC | 4 | 2 | 0 |
| 10 | Takeda Manufacturing Austria AG | 4 | 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
97 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2024/08/20New drug · Class 1 | 洛布替尼片 · No verified English nameCXHL2400850 | Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized |
| 2024/08/19New drug · Class 1 | RJMty19注射液 · No verified English nameCXSL2400553 | Zhejiang Rui Jia Mei Bio Technology Co., Ltd. romanized |
| 2024/08/17Import · Class 1 | AZD5492 · No verified English nameJXSL2400149 | AstraZeneca AB; AstraZeneca Global ll&U (China) Co. Ltd. |
| 2024/08/17Generic · Class 3 | Bumetanide InjectionCYHS2402684 | Sichuan Wo Xiang Biopharmaceuticals Co., Ltd. romanized; Chengdu Di Yi Pharmaceutical Co., Ltd. romanized |
| 2024/08/17Generic · Class 3 | Sodium Tetradecyl Sulphate InjectionCYHL2400167 | Shanghai Shang Yao Di Yi Sheng Hua Pharma Co., Ltd. romanized |
| 2024/08/17Generic · Class 3 | Sodium Tetradecyl Sulphate InjectionCYHL2400166 | Shanghai Shang Yao Di Yi Sheng Hua Pharma Co., Ltd. romanized |
| 2024/08/17Generic · Class 3 | 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2400165 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2024/08/17New drug · Class 1 | SYS6026注射液 · No verified English nameCXSL2400552 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2024/08/17New drug · Class 1 | LAT010注射液 · No verified English nameCXSL2400551 | Lai Te Kang (Suzhou) Biopharmaceutical Co., Ltd. romanized |
| 2024/08/17New drug · Class 1 | G01滴眼液 · No verified English nameCXSL2400550 | Qingdao Wan Ming Sai Bo Biopharmaceuticals Co., Ltd. romanized |
| 2024/08/17New drug · Class 1 | G01滴眼液 · No verified English nameCXSL2400549 | Qingdao Wan Ming Sai Bo Biopharmaceuticals Co., Ltd. romanized |
| 2024/08/17New drug · Class 1 | G01滴眼液 · No verified English nameCXSL2400548 | Qingdao Wan Ming Sai Bo Biopharmaceuticals Co., Ltd. romanized |
| 2024/08/17New drug · Class 1 | 重组全人源抗PCSK9单克隆抗体注射液 · No verified English nameCXSL2400547 | Xin Li Tai (Chengdu) Bio Technology Co., Ltd. romanized; Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
67 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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