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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 340 drug applications between 25 October 2024 and 31 October 2024 (data as of 14 November 2026 06:00). Of these, generic applications numbered 100, covering 67 drug names.

2024/10/25 – 2024/10/31

Period
2024/10/25 to 2024/10/31, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
340
Drugs with new generic filings (by drug name, de-duplicated)
67
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

340filings, 100 of them generic

By application type

Application typeFilings
Supplement165
Generic100
New drug49
Unspecified13
Import10
Import re-registration3

By drug type

Drug typeFilings
Chemical drug219
TCM70
Therapeutic biologic37
Biologic10
Prophylactic biologic4

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

67 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets8458
2Methotrexate Injection6111
3维生素B6注射液 · No verified English name449
4Oseltamivir Phosphate For Oral Suspension322
5Febuxostat Tablets3212
6Crisaborole Ointment2226
7Diquafosol Sodium Eye Drops225
8Brexpiprazole Tablets2231
9Metoclopramide Hydrochloride Injection226
10Lactated Ringer's Injection215

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

191 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangdong Sunho Pharmaceutical Co., Ltd.35260
2Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized21170
3Novo Nordisk A/S1520
4Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized616
5Jilin Sheng Shang Cheng Pharma Co., Ltd. romanized440
6Shandong Qidu Pharmaceutical Co., Ltd.434
7Amgen Inc.420
8Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized333
9Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized330
10Zhongguo Yi Xue Ke College Yi Xue Bio Xue Research Institute romanized320

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

100 this week

AcceptedDrugApplicants
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.
2024/10/31Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2403691 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Nanchang Li Jian Pharma Co., Ltd. romanized
2024/10/31Generic · Class 3 Nitroglycerin InjectionCYHS2403689 Hainan Wei Jian Pharma Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2024/10/31Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2403688 Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanized
2024/10/31Generic · Class 3 Doxofylline TabletsCYHS2403684 Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized
2024/10/31Generic · Class 3 Doxofylline TabletsCYHS2403683 Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized
2024/10/31New drug · Class 1.1 HC009合剂 · No verified English nameCXZL2400074 Beijing Hou Cheng Pharmaceuticals Technology Co., Ltd. romanized
2024/10/31New drug · Class 1 注射用芦康沙妥珠单抗 · No verified English nameCXSS2400117 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2024/10/31New drug · Class 1 PJ008注射液 · No verified English nameCXSL2400745 Chongqing Pai Jin Bio Technology Co., Ltd. romanized
2024/10/31New drug · Class 2.2 HB018口溶膜 · No verified English nameCXHL2401151 Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized
2024/10/31New drug · Class 2.2 HB018口溶膜 · No verified English nameCXHL2401150 Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized
2024/10/31New drug · Class 2.2 HB018口溶膜 · No verified English nameCXHL2401149 Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized
2024/10/31New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2401148 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/10/31New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2401147 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/10/30Import · Class 2.2 Tarlatamab · No verified English nameJXSL2400208 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2024/10/30Import · Class 2.2 Tarlatamab · No verified English nameJXSL2400207 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2024/10/30Import · Class 2.2 Tarlatamab · No verified English nameJXSL2400206 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2024/10/30Import · Class 2.3; 2.4 MRG-001注射液 · No verified English nameJXHL2400259 MEDREGEN LLC; Hangzhou Tigermed Consulting Co. Ltd.
2024/10/30Generic · Class 3 Potassium Phosphates InjectionCYHS2403682 Guangdong Mai De Fa Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/10/30Generic · Class 3 Metoprolol Succinate Extended-release CapsulesCYHS2403679 Shanghai Hui Yong Pharmaceutical Co., Ltd. romanized
2024/10/30Generic · Class 3 Calcium Acetate Oral SolutionCYHS2403678 Hefei En Rui Te Pharma Co., Ltd. romanized
2024/10/30Generic · Class 3 Obeticholic Acid TabletsCYHS2403677 Tai Zhou Fu Dan Zhang Jiang Pharma Co., Ltd. romanized
2024/10/30Generic · Class 3 Obeticholic Acid TabletsCYHS2403676 Tai Zhou Fu Dan Zhang Jiang Pharma Co., Ltd. romanized
2024/10/30Generic · Class 3 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2400213 Jiangsu Run Bang Pharma Co., Ltd. romanized
2024/10/30New drug · Class 1.1 仙茜颗粒 · No verified English nameCXZL2400073 Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized
2024/10/30New drug · Class 1.1 BYS30颗粒 · No verified English nameCXZL2400072 Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized
2024/10/30New drug · Class 1 OCUL101注射液 · No verified English nameCXSL2400744 Shenzhen Ou Ke Jian Biopharmaceuticals Technology Co., Ltd. romanized

70 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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