YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 97 drug applications between 4 October 2024 and 10 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 26, covering 22 drug names.

2024/10/04 – 2024/10/10

Period
2024/10/04 to 2024/10/10, 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
97
Drugs with new generic filings (by drug name, de-duplicated)
22
Accepted this week, now under review
1

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

97filings, 26 of them generic

By application type

Application typeFilings
Supplement46
Generic26
New drug13
Import6
Unspecified4
Import re-registration2

By drug type

Drug typeFilings
Chemical drug60
Therapeutic biologic21
TCM13
Biologic2
Prophylactic biologic1

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

22 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1ω-3 Fish Oil Fat Emulsion Injection216
2Piracetam Injection219
3Sodium Hyaluronate Eye Drops2130
4Dopamine Hydrochloride Injection213
5Ethyl Iosapentate Capsules1127
6Linaclotide Capsules1113
7Carbazochrome Sodium Sulfonate Injection111
8Celecoxib Capsules115
9Potassium Phosphates Injection112
10Fusidic Acid Cream1115

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

71 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company520
2Bristol-Myers Squibb Pharma EEIG410
3Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized323
4Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized320
5Janssen-Cilag International NV220
6Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized220
7Chongqing Xi Er An Pharma Co., Ltd. romanized220
8Qilu Pharmaceutical Co., Ltd.220
9Chiesi Farmaceutici S.p.A.210
10Jenapharm GmbH & Co. KG210

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

30 this week

AcceptedDrugApplicants
2024/10/10Generic · Class 3 Potassium Phosphates InjectionCYHS2403354 Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/10/10Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2403351 Yao Su (Shanghai) Medical Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized
2024/10/10Generic · Class 3 Doxercalciferol InjectionCYHS2403349 Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized
2024/10/10Generic · Class 3 Piracetam InjectionCYHS2403348 Shandong Li Nuo Pharmaceutical Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized
2024/10/10Generic · Class 3 Piracetam InjectionCYHS2403347 Shandong Li Nuo Pharmaceutical Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized
2024/10/10Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2403345 Anhui Bo Nuo Mei Ke Biopharmaceuticals Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized
2024/10/10New drug · Class 3.1 桃红四物颗粒 · No verified English nameCXZS2400033 Shen Wei Pharma Group Co., Ltd. romanized
2024/10/10New drug · Class 1 注射用MHB039A · No verified English nameCXSL2400680 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2024/10/10New drug · Class 1 注射用MHB036C · No verified English nameCXSL2400679 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2024/10/10New drug · Class 1 注射用MHB036C · No verified English nameCXSL2400678 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2024/10/10New drug · Class 1 注射用SHR-1681 · No verified English nameCXSL2400677 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/10/10New drug · Class 1 TAN-118片 · No verified English nameCXHL2401039 Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized
2024/10/10New drug · Class 1 TAN-118片 · No verified English nameCXHL2401038 Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized
2024/10/09Import · Class 2.2 米吉珠单抗注射液(皮下注射) · No verified English nameJXSS2400083 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/09Import · Class 2.2 米吉珠单抗注射液(皮下注射) · No verified English nameJXSS2400082 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/09Import · Class 2.2 米吉珠单抗注射液(皮下注射) · No verified English nameJXSS2400081 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/09Import · Class 2.2 米吉珠单抗注射液(皮下注射) · No verified English nameJXSS2400080 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/09Import · Class 2.2 米吉珠单抗注射液 · No verified English nameJXSS2400079 Eli Lilly and Company; BSP PHARMACEUTICALS S.P.A.; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/09Import · Class 1 VHB937注射用浓溶液 · No verified English nameJXSL2400190 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/10/09Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2403343 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2024/10/09Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2403342 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2024/10/09Generic · Class 3 Aminocaproic Acid InjectionCYHS2403337 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2024/10/09Generic · Class 3 Chlorphenamine Maleate InjectionCYHS2403333 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2024/10/09Generic · Class 3 Potassium Chloride Oral SolutionCYHS2403332 Jiangxi Bo Tai Pharma Co., Ltd. romanized; Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized
2024/10/09New drug · Class 1.1 柴金散结颗粒 · No verified English nameCXZL2400064 Guangdong Kai Zhong Bio Technology Co., Ltd. romanized
2024/10/09New drug · Class 3.4 人纤维蛋白原 · No verified English nameCXSS2400108 Tong Lu Biopharmaceutical Co., Ltd. romanized
2024/10/09New drug · Class 3.3 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2400676 Changchun Bai Ke Bio Technology Shareholding Company romanized
2024/10/09New drug · Class 2.2 1646A干混悬剂 · No verified English nameCXHL2401037 Pu Zhao Guo Kang (Hubei) Pharma Co., Ltd. romanized
2024/10/09New drug · Class 1 [177Lu]Lu-XT117注射液 · No verified English nameCXHL2401036 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized
2024/10/08New drug · Class 1 JKN2403片 · No verified English nameCXHL2401035 Health Yuan Pharma Group Co., Ltd. romanized

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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