YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 362 drug applications between 26 October 2024 and 1 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 98, covering 71 drug names.
2024/10/26 – 2024/11/01
- New acceptances this week
- 362
- Drugs with new generic filings (by drug name, de-duplicated)
- 71
- 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
362filings, 98 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 186 |
| Generic | 98 |
| New drug | 52 |
| Import | 13 |
| Unspecified | 11 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 228 |
| TCM | 84 |
| Therapeutic biologic | 39 |
| Biologic | 6 |
| Prophylactic biologic | 5 |
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
71 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 8 | 4 | 60 |
| 2 | Oseltamivir Phosphate For Oral Suspension | 3 | 2 | 2 |
| 3 | Febuxostat Tablets | 3 | 2 | 12 |
| 4 | Ampicillin Sodium and Sulbactam Sodium for Injection | 3 | 1 | 13 |
| 5 | Crisaborole Ointment | 2 | 2 | 26 |
| 6 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 7 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 8 | 盐酸纳美芬注射液 · No verified English name | 2 | 2 | 1 |
| 9 | Lactated Ringer's Injection | 2 | 1 | 5 |
| 10 | Doxofylline Tablets | 2 | 1 | 2 |
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
212 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangdong Sunho Pharmaceutical Co., Ltd. | 29 | 24 | 0 |
| 2 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 21 | 17 | 0 |
| 3 | Novo Nordisk A/S | 11 | 3 | 0 |
| 4 | Jilin Sheng Shang Cheng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Amgen Inc. | 4 | 2 | 0 |
| 8 | Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized | 3 | 3 | 3 |
| 9 | Xian Bei Lin Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Janssen-Cilag International NV | 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
105 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2024/11/01Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2403718 | Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized |
| 2024/11/01Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2403717 | Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized |
| 2024/11/01Generic · Class 3 | Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2403716 | Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2024/11/01Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2403715 | Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2024/11/01Generic · Class 3 | Lamivudine and Tenofovir Disoproxil Fumarate TabletsCYHS2403711 | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized |
| 2024/11/01Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2403710 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2024/11/01Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2403709 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2024/11/01Generic · Class 3 | 托吡酯口服溶液 · No verified English nameCYHS2403708 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2024/11/01Generic · Class 3 | 复方葡萄糖/电解质颅脑手术冲洗液 · No verified English nameCYHS2403702 | Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2024/11/01New drug · Class 1 | SYS6041 · No verified English nameCXSL2400746 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2024/11/01New drug · Class 2.4; 2.2 | 马来酸噻吗洛尔凝胶 · No verified English nameCXHS2400111 | Shanghai Ao Quan Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Xin Ya Pharma Min Xing Co., Ltd. romanized |
| 2024/11/01New drug · Class 1 | HY-072808软膏 · No verified English nameCXHL2401156 | Hefei En Rui Te Pharma Co., Ltd. romanized; Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized |
| 2024/11/01New drug · Class 1 | HY-072808软膏 · No verified English nameCXHL2401155 | Hefei En Rui Te Pharma Co., Ltd. romanized; Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized |
| 2024/11/01New drug · Class 2.2 | HQ2216注射液 · No verified English nameCXHL2401154 | Bai Cheng Pharmaceuticals (Zhuhai Heng Qin) Co., Ltd. romanized |
| 2024/11/01New drug · Class 1 | 苯磺酸CG-0255胶囊 · No verified English nameCXHL2401153 | Shanghai Ke Jun Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Ke Jin Zi Xun Management Co., Ltd. romanized |
| 2024/11/01New drug · Class 1 | 苯磺酸CG-0255胶囊 · No verified English nameCXHL2401152 | Shanghai Ke Jun Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Ke Jin Zi Xun Management Co., Ltd. romanized |
| 2024/10/31Generic · Class 3 | 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2403697 | Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; Ji Chuan Pharma Group Co., Ltd. romanized |
| 2024/10/31Generic · Class 3 | Pentoxifylline Modified Release TabletsCYHS2403696 | Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2024/10/31Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2403695 | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2024/10/31Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2403694 | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
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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