YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 344 drug applications between 29 October 2024 and 4 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 94, covering 68 drug names.
2024/10/29 – 2024/11/04
- New acceptances this week
- 344
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- Accepted this week, now under review
- 2
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
344filings, 94 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 172 |
| Generic | 94 |
| New drug | 52 |
| Import | 12 |
| Unspecified | 11 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 213 |
| TCM | 85 |
| Therapeutic biologic | 34 |
| Biologic | 6 |
| Prophylactic biologic | 6 |
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 | Vonoprazan Fumarate Tablets | 6 | 3 | 60 |
| 2 | Doxofylline Tablets | 4 | 2 | 2 |
| 3 | Oseltamivir Phosphate For Oral Suspension | 3 | 2 | 2 |
| 4 | Ampicillin Sodium and Sulbactam Sodium for Injection | 3 | 1 | 13 |
| 5 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 6 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 7 | 盐酸纳美芬注射液 · No verified English name | 2 | 2 | 1 |
| 8 | Potassium Aspartate And Magnesium Aspartate Injection | 2 | 2 | 3 |
| 9 | Ezetimibe and Atorvastatin Calcium Trihydrate Tablets | 2 | 1 | 4 |
| 10 | Obeticholic Acid Tablets | 2 | 1 | 0 |
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 | Guangdong Sunho Pharmaceutical Co., Ltd. | 16 | 13 | 0 |
| 2 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 16 | 12 | 0 |
| 3 | Novo Nordisk A/S | 11 | 3 | 0 |
| 4 | Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | Amgen Inc. | 4 | 2 | 0 |
| 6 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 3 | 3 | 0 |
| 7 | Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 8 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Xian Bei Lin Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Zhongguo Yi Xue Ke College Yi Xue Bio Xue Research Institute romanized | 3 | 2 | 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
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/11/04New drug · Class 1.3 | ZY022胶囊 · No verified English nameCXZL2400076 | Zhongguo Yi Xue Ke College Drug Research Institute romanized; Hunan Sheng Tian Ji Zhen Xi Zhong Yao Cai Development Co., Ltd. romanized |
| 2024/11/04New drug · Class 1.3 | ZY022 · No verified English nameCXZL2400075 | Zhongguo Yi Xue Ke College Drug Research Institute romanized; Hunan Sheng Tian Ji Zhen Xi Zhong Yao Cai Development Co., Ltd. romanized |
| 2024/11/02Generic · Class 3 | Phloroglucinol Orally Disintegrating TabletsCYHS2403744 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/11/02Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2403743 | Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized |
| 2024/11/02Generic · Class 3 | Doxofylline TabletsCYHS2403742 | Zhejiang Hua Yuan Pharma Co., Ltd. romanized |
| 2024/11/02Generic · Class 3 | Doxofylline TabletsCYHS2403741 | Zhejiang Hua Yuan Pharma Co., Ltd. romanized |
| 2024/11/02Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2403734 | Ping Guang Pharmaceutical Co., Ltd. romanized |
| 2024/11/02Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2403730 | Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2024/11/02New drug · Class 3.3 | 流感病毒裂解疫苗 · No verified English nameCXSS2400118 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2024/11/02New drug · Class 1 | 注射用HLX43 · No verified English nameCXSL2400747 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2024/11/02New drug · Class 1 | SYHA1813口服溶液 · No verified English nameCXHL2401166 | Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/02New drug · Class 1 | SYHA1813口服溶液 · No verified English nameCXHL2401165 | Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/02New drug · Class 1 | SYHA1813口服溶液 · No verified English nameCXHL2401164 | Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/02New drug · Class 2.3 | HQ2303 · No verified English nameCXHL2401163 | Bai Cheng Pharmaceuticals (Zhuhai Heng Qin) Co., Ltd. romanized |
| 2024/11/02New drug · Class 1 | 注射用MB0151 · No verified English nameCXHL2401162 | Zhu Liu Yuan Bio Technology (Shanghai) Co., Ltd. romanized; Zhong Shan Zhu Liu Yuan Bio Technology Co., Ltd. romanized |
| 2024/11/02New drug · Class 2.1; 2.4 | 盐酸(R)-氯胺酮注射液 · No verified English nameCXHL2401161 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2024/11/02New drug · Class 1 | SYHX1901片 · No verified English nameCXHL2401160 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2024/11/02New drug · Class 2.1; 2.4 | 盐酸(R)-氯胺酮注射液 · No verified English nameCXHL2401159 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2024/11/02New drug · Class 1 | SYHX1901片 · No verified English nameCXHL2401158 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2024/11/02New drug · Class 2.2 | BN020827H · No verified English nameCXHL2401157 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2024/11/01Import · Class 2.2 | 注射用德曲妥珠单抗 · No verified English nameJXSL2400211 | Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2024/11/01Import · Class 1 | PIT565 · No verified English nameJXSL2400210 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/11/01Import · Class 3.1 | 13价肺炎球菌多糖结合疫苗 · No verified English nameJXSL2400209 | Pfizer Europe MA EEIG; Pfizer Investment CO. Ltd. |
| 2024/11/01Import · Class 2.4 | BMS-986165片 · No verified English nameJXHL2400262 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2024/11/01Import · Class 2.4 | BMS-986165片 · No verified English nameJXHL2400261 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2024/11/01Import · Class 2.4 | BMS-986165片 · No verified English nameJXHL2400260 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2024/11/01Generic · Class 3 | Multiple Electrolyte Additive For InjectionCYHS2403726 | Henan Shang Heng Pharmaceuticals Technology Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized |
| 2024/11/01Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2403723 | Gansu Nong Ken Drug Jian Factory Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized |
| 2024/11/01Generic · Class 3 | Lorazepam TabletsCYHS2403722 | Beijing Yi Min Pharma Co., Ltd. romanized |
| 2024/11/01Generic · Class 3 | Progesterone InjectionCYHS2403721 | Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized |
72 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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