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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 362 drug applications between 24 October 2024 and 30 October 2024 (data as of 14 November 2026 06:00). Of these, generic applications numbered 103, covering 68 drug names.

2024/10/24 – 2024/10/30

Period
2024/10/24 to 2024/10/30, 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
362
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

362filings, 103 of them generic

By application type

Application typeFilings
Supplement175
Generic103
New drug53
Import16
Unspecified12
Import re-registration3

By drug type

Drug typeFilings
Chemical drug231
TCM72
Therapeutic biologic43
Biologic10
Prophylactic biologic6

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

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets8458
2Methotrexate Injection6111
3维生素B6注射液 · No verified English name449
4Febuxostat Tablets3212
5Crisaborole Ointment2226
6Diquafosol Sodium Eye Drops225
7Brexpiprazole Tablets2231
8氯化钙注射液 · No verified English name226
9Metoclopramide Hydrochloride Injection226
10Iguratimod Tablets2223

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

210 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangdong Sunho Pharmaceutical Co., Ltd.33240
2Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized15130
3Novo Nordisk A/S1520
4Jilin Sheng Shang Cheng Pharma Co., Ltd. romanized760
5Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized616
6Hua Chuan Pharmaceutical Co., Ltd. romanized440
7Shandong Qidu Pharmaceutical Co., Ltd.434
8Shenyang Dong Xin Pharma Co., Ltd. romanized430
9Shanghai Min Wei Bio Technology Co., Ltd. romanized410
10Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized333

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

107 this week

AcceptedDrugApplicants
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
2024/10/30New drug · Class 1 OCUL101注射液 · No verified English nameCXSL2400743 Shenzhen Ou Ke Jian Biopharmaceuticals Technology Co., Ltd. romanized
2024/10/30New drug · Class 1 OCUL101注射液 · No verified English nameCXSL2400742 Shenzhen Ou Ke Jian Biopharmaceuticals Technology Co., Ltd. romanized
2024/10/30New drug · Class 2.2 恩朗苏拜单抗注射液 · No verified English nameCXSL2400741 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/10/30New drug · Class 1 HM2002注射液 · No verified English nameCXSL2400740 Shanghai Huan Ma Biopharmaceuticals Co., Ltd. romanized
2024/10/30New drug · Class 1 BAT1308注射液 · No verified English nameCXSL2400739 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/10/30New drug · Class 1 注射用BAT8007 · No verified English nameCXSL2400738 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/10/30New drug · Class 1 RC148注射液 · No verified English nameCXSL2400737 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2024/10/30New drug · Class 3.2 重组人促卵泡激素-CTP融合蛋白注射液 · No verified English nameCXSL2400736 Suzhou Jing Ze Biopharmaceuticals Co., Ltd. romanized
2024/10/30New drug · Class 2.2 HXASP028 · No verified English nameCXHL2401146 Guangxi Shan He Bai Sheng Technology Co., Ltd. romanized
2024/10/30New drug · Class 2.2 HXASP028 · No verified English nameCXHL2401145 Guangxi Shan He Bai Sheng Technology Co., Ltd. romanized
2024/10/30New drug · Class 1 HRN01片 · No verified English nameCXHL2401144 Beijing Hua Rui Ding Xin Technology Co., Ltd. romanized
2024/10/30New drug · Class 1 HRN01片 · No verified English nameCXHL2401143 Beijing Hua Rui Ding Xin Technology Co., Ltd. romanized
2024/10/29Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2403665 Henan Li Heng Pharmaceuticals Technology Co., Ltd. romanized; Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized
2024/10/29Generic · Class 3 Sodium Nitroprusside InjectionCYHS2403660 Shandong Qidu Pharmaceutical Co., Ltd.
2024/10/29Generic · Class 3 Cetylpyridinium Chloride Buccal TabletsCYHS2403659 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Rui Hua (Zhong Shan) Pharmaceutical Co., Ltd. romanized
2024/10/29Generic · Class 3 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2403657 Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized
2024/10/29Generic · Class 3 Ibuprofen InjectionCYHL2400212 Hua Zhong Pharma Co., Ltd. romanized

77 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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