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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

Period
2024/10/26 to 2024/11/01, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
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 typeFilings
Supplement186
Generic98
New drug52
Import13
Unspecified11
Import re-registration2

By drug type

Drug typeFilings
Chemical drug228
TCM84
Therapeutic biologic39
Biologic6
Prophylactic biologic5

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

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets8460
2Oseltamivir Phosphate For Oral Suspension322
3Febuxostat Tablets3212
4Ampicillin Sodium and Sulbactam Sodium for Injection3113
5Crisaborole Ointment2226
6Diquafosol Sodium Eye Drops225
7Metoclopramide Hydrochloride Injection226
8盐酸纳美芬注射液 · No verified English name221
9Lactated Ringer's Injection215
10Doxofylline Tablets212

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)FilingsDrugsGeneric
1Guangdong Sunho Pharmaceutical Co., Ltd.29240
2Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized21170
3Novo Nordisk A/S1130
4Jilin Sheng Shang Cheng Pharma Co., Ltd. romanized440
5Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized440
6Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized440
7Amgen Inc.420
8Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized333
9Xian Bei Lin Pharma Co., Ltd. romanized330
10Janssen-Cilag International NV320

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

AcceptedDrugApplicants
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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