YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 570 drug applications between 11 October 2024 and 17 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 167, covering 124 drug names.
2024/10/11 – 2024/10/17
- New acceptances this week
- 570
- Drugs with new generic filings (by drug name, de-duplicated)
- 124
- Accepted this week, now under review
- 4
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
570filings, 167 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 242 |
| Generic | 167 |
| New drug | 97 |
| Import | 38 |
| Import re-registration | 14 |
| Unspecified | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 394 |
| TCM | 94 |
| Therapeutic biologic | 73 |
| Prophylactic biologic | 5 |
| Biologic | 4 |
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
124 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Fusidic Acid Cream | 5 | 2 | 15 |
| 2 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 3 | 3 | 8 |
| 3 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 4 | Hydrocortisone Sodium Succinate for Injection | 3 | 2 | 16 |
| 5 | Bupivacaine Hydrochloride Injection | 3 | 1 | 4 |
| 6 | Fudosteine oral solution | 3 | 1 | 7 |
| 7 | Dasatinib Tablets | 3 | 1 | 4 |
| 8 | Bromhexine Hydrochloride Injection | 2 | 2 | 8 |
| 9 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 10 | 维生素B6注射液 · No verified English name | 2 | 2 | 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
351 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Janssen-Cilag International NV | 9 | 6 | 0 |
| 2 | Guizhou Ke Lun Pharma Co., Ltd. romanized | 9 | 3 | 1 |
| 3 | Bristol-Myers Squibb Pharma EEIG | 7 | 3 | 0 |
| 4 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 7 | 1 | 0 |
| 5 | Bard Pharmaceuticals Limited | 6 | 6 | 0 |
| 6 | AstraZeneca AB | 6 | 4 | 0 |
| 7 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 4 | 0 |
| 8 | Novo Nordisk A/S | 6 | 2 | 0 |
| 9 | Jiangsu Shen Hua Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 4 | 3 |
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
184 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/10/17Import · Class 3.1 | 注射用sotatercept · No verified English nameJXSS2400095 | Merck Sharp & Dohme LLC; Patheon Italia S.p.A.; MSD R&D (China) Co. Ltd. |
| 2024/10/17Import · Class 3.1 | 注射用sotatercept · No verified English nameJXSS2400094 | Merck Sharp & Dohme LLC; Patheon Italia S.p.A.; MSD R&D (China) Co. Ltd. |
| 2024/10/17Import · Class 1 | 注射用Budigalimab · No verified English nameJXSL2400195 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/10/17Import · Class 1 | ABBV-400注射用粉末 · No verified English nameJXSL2400194 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/10/17Generic · Class 3 | 维生素B??注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2403517 | Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized |
| 2024/10/17Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2403516 | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2024/10/17Generic · Class 3 | Vigabatrin Powder for Oral SolutionCYHS2403515 | Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized |
| 2024/10/17Generic · Class 3 | Venlafaxine Hydrochloride Extended Release TabletsCYHS2403508 | Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized |
| 2024/10/17Generic · Class 3 | Levofloxacin InjectionCYHS2403507 | YaoPharma Co., Ltd. |
| 2024/10/17Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2403502 | Guangdong Yue He Ze Drug Research Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/10/17Generic · Class 3 | 盐酸多沙普仑注射液 · No verified English nameCYHS2403501 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/10/17Generic · Class 3 | Ferric Maltol CapsulesCYHL2400203 | Hangzhou Qian Yuan Bao Ling Pharma Co., Ltd. romanized |
| 2024/10/17Generic · Class 3 | Relugolix TabletsCYHL2400202 | Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2024/10/17New drug · Class 1 | 注射用Zilovertamab vedotin · No verified English nameCXSL2400708 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2024/10/17New drug · Class 1 | 注射用MK-6204(SKB535) · No verified English nameCXSL2400707 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2024/10/17New drug · Class 1 | 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2400706 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2024/10/17New drug · Class 1 | 重组红细胞生成刺激蛋白注射液(CHO细胞) · No verified English nameCXSL2400705 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2024/10/17New drug · Class 1 | SYS6043 · No verified English nameCXSL2400704 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2024/10/17New drug · Class 1 | RC1416注射液 · No verified English nameCXSL2400703 | Nanjing Rong Jie Kang Bio Technology Co., Ltd. romanized |
| 2024/10/17New drug · Class 1 | RC1416注射液 · No verified English nameCXSL2400702 | Nanjing Rong Jie Kang Bio Technology Co., Ltd. romanized |
| 2024/10/17New drug · Class 1 | CD-001注射液 · No verified English nameCXSL2400701 | Cheng Dian (Suzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2024/10/17New drug · Class 1 | 注射用ZG005 · No verified English nameCXSL2400700 | Name not romanized; Name not romanized |
| 2024/10/17New drug · Class 2.2 | BCM851口溶膜 · No verified English nameCXHL2401099 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized |
| 2024/10/17New drug · Class 2.2 | BCM851口溶膜 · No verified English nameCXHL2401098 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized |
| 2024/10/17New drug · Class 2.2 | BCM851口溶膜 · No verified English nameCXHL2401097 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized |
| 2024/10/17New drug · Class 2.2 | BCM851口溶膜 · No verified English nameCXHL2401096 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized |
| 2024/10/17New drug · Class 1 | H002胶囊 · No verified English nameCXHL2401095 | Tai Zhou Hong Yun Pharmaceutical Co., Ltd. romanized |
| 2024/10/17New drug · Class 1 | 盐酸吉卡昔替尼片 · No verified English nameCXHL2401094 | Name not romanized; Name not romanized |
| 2024/10/16Generic · Class 3 | Alendronate Sodium Oral SolutionCYHS2403492 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2024/10/16Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2403488 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
154 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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