YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 314 drug applications between 30 August 2023 and 5 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 101, covering 74 drug names.
2023/08/30 – 2023/09/05
- New acceptances this week
- 314
- Drugs with new generic filings (by drug name, de-duplicated)
- 74
- Accepted this week, now under review
- 0
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
314filings, 101 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 136 |
| Generic | 101 |
| New drug | 58 |
| Import | 12 |
| Import re-registration | 5 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 219 |
| TCM | 51 |
| Therapeutic biologic | 36 |
| Prophylactic biologic | 6 |
| In vitro diagnostic reagent | 1 |
| 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
74 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Phloroglucinol Injection | 4 | 4 | 2 |
| 2 | Nicorandil for Injection | 3 | 2 | 1 |
| 3 | Etoricoxib Tablets | 3 | 1 | 8 |
| 4 | Quetiapine Fumarate Tablets | 3 | 1 | 0 |
| 5 | Tadalafil Tablets | 2 | 2 | 23 |
| 6 | Nicorandil Tablets | 2 | 2 | 4 |
| 7 | Pentoxifylline Injection | 2 | 2 | 3 |
| 8 | Potassium Chloride Injection | 2 | 2 | 10 |
| 9 | Lornoxicam for Injection | 2 | 2 | 2 |
| 10 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 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
208 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guizhou Rui He Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Shenyang Hong Yao Group Co., Ltd. romanized | 4 | 3 | 0 |
| 4 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 4 | 3 | 0 |
| 5 | Rui Yang Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 6 | Organon Pharma (UK) Limited | 4 | 1 | 0 |
| 7 | Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Shenzhen Jia Ke Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | CISEN PHARMACEUTICAL CO., LTD. | 4 | 1 | 0 |
| 10 | Jewim Pharmaceutical (Shandong) Co., Ltd. | 3 | 3 | 2 |
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
105 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/05Import · Class 3.1 | 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300076 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland; MSD R&D (China) Co. Ltd. |
| 2023/09/05Import · Class 3.1 | 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300075 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland; MSD R&D (China) Co. Ltd. |
| 2023/09/05Import · Class 1 | JDQ443片 · No verified English nameJXHL2300202 | Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd |
| 2023/09/05Import · Class 1 | DMX-200 · No verified English nameJXHL2300201 | Dimerix Bioscience Pty Ltd; IQVIA RDS (Shanghai) Co. Ltd. |
| 2023/09/05Generic · Class 3 | Amoxicillin Sodium for InjectionCYHS2302386 | Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized |
| 2023/09/05Generic · Class 3 | Amoxicillin Sodium for InjectionCYHS2302385 | Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized |
| 2023/09/05Generic · Class 3 | Metaraminol Tartrate InjectionCYHS2302378 | Anhui Mei Lai Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
| 2023/09/05Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2302377 | Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized |
| 2023/09/05Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2302376 | Anhui Heng Xing Pharmaceutical Co., Ltd. romanized |
| 2023/09/05Generic · Class 3 | 美洛昔康纳米晶注射液 · No verified English nameCYHL2300112 | Health Yuan Pharma Group Co., Ltd. romanized |
| 2023/09/05New drug · Class 1.1 | 藿夏感冒颗粒 · No verified English nameCXZL2300059 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2023/09/05New drug · Class 1 | 舒西利单抗注射液 · No verified English nameCXSS2300072 | Zhong Kang Biopharmaceutical (Haikou) Co., Ltd. romanized |
| 2023/09/05New drug · Class 2.1 | 重组人CTLA-4变体Fc融合蛋白注射液 · No verified English nameCXSL2300600 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2023/09/05New drug · Class 1 | HS-IT101注射液 · No verified English nameCXSL2300599 | Qingdao Hua Sai Bo Man Yi Xue Xi Bao Bio Co., Ltd. romanized |
| 2023/09/05New drug · Class 1 | 注射用SHR-A2009 · No verified English nameCXSL2300598 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/05New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2300597 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/05New drug · Class 1 | T3011疱疹病毒注射液 · No verified English nameCXSL2300596 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2023/09/05New drug · Class 1 | WBC100胶囊 · No verified English nameCXHL2300954 | Hangzhou Wei Ben Pharma Co., Ltd. romanized |
| 2023/09/05New drug · Class 2.2 | 注射用醋酸丙氨瑞林微球 · No verified English nameCXHL2300953 | Shanghai Li Zhu Pharmaceutical Co., Ltd. romanized |
| 2023/09/05New drug · Class 2.3 | QLM2010 · No verified English nameCXHL2300952 | Qilu Pharmaceutical Co., Ltd. |
| 2023/09/05New drug · Class 1 | TY705注射液 · No verified English nameCXHL2300951 | Tianjin Drug Research Institute Co., Ltd. romanized |
| 2023/09/05New drug · Class 1 | TY705注射液 · No verified English nameCXHL2300950 | Tianjin Drug Research Institute Co., Ltd. romanized |
| 2023/09/05New drug · Class 1 | JK0003片 · No verified English nameCXHL2300949 | Shenzhen Jia Ke Bio Technology Co., Ltd. romanized |
| 2023/09/05New drug · Class 1 | JK0003片 · No verified English nameCXHL2300948 | Shenzhen Jia Ke Bio Technology Co., Ltd. romanized |
| 2023/09/05New drug · Class 1 | JK0003片 · No verified English nameCXHL2300947 | Shenzhen Jia Ke Bio Technology Co., Ltd. romanized |
| 2023/09/05New drug · Class 1 | JK0003片 · No verified English nameCXHL2300946 | Shenzhen Jia Ke Bio Technology Co., Ltd. romanized |
| 2023/09/04Generic · Class 3 | Pentoxifylline InjectionCYHS2302369 | Shanxi Hui Da Lin Xi Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized |
| 2023/09/02Generic · Class 3 | Potassium Chloride InjectionCYHS2302366 | Hainan Ou Ruo La Bio Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2023/09/02Generic · Class 3 | Indobufen TabletsCYHS2302365 | Shenzhen Shi Lang Bo Biopharmaceuticals Co., Ltd. romanized; Ya Bao Pharma Tai Yuan Pharmaceutical Co., Ltd. romanized |
| 2023/09/02Generic · Class 3 | Indobufen TabletsCYHS2302364 | Shenzhen Shi Lang Bo Biopharmaceuticals Co., Ltd. romanized; Ya Bao Pharma Tai Yuan Pharmaceutical Co., Ltd. romanized |
75 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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