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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 506 drug applications between 9 October 2024 and 15 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 147, covering 108 drug names.

2024/10/09 – 2024/10/15

Period
2024/10/09 to 2024/10/15, 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
506
Drugs with new generic filings (by drug name, de-duplicated)
108
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

506filings, 147 of them generic

By application type

Application typeFilings
Supplement222
Generic147
New drug77
Import35
Import re-registration13
Unspecified12

By drug type

Drug typeFilings
Chemical drug358
TCM77
Therapeutic biologic65
Biologic4
Prophylactic biologic2

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

108 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Fusidic Acid Cream6315
2Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution338
3Vonoprazan Fumarate Tablets3260
4Bupivacaine Hydrochloride Injection314
5Fudosteine oral solution317
6Dasatinib Tablets314
7Potassium Chloride Oral Solution2211
8Glucosamine Sulfate Capsules2251
9Iguratimod Tablets2223
10ω-3 Fish Oil Fat Emulsion Injection216

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

301 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bristol-Myers Squibb Pharma EEIG1140
2Guizhou Ke Lun Pharma Co., Ltd. romanized931
3Janssen-Cilag International NV860
4Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.710
5Bard Pharmaceuticals Limited660
6Jiangsu Shen Hua Pharma Co., Ltd. romanized550
7AstraZeneca AB540
8Merck Sharp & Dohme B.V.530
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
10Eli Lilly and Company520

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

161 this week

AcceptedDrugApplicants
2024/10/15Import · Class 1 Aficamten片 · No verified English nameJXHS2400085 Cytokinetics Incorporated; Patheon Inc.; Sanofi (China) Investment Co. Ltd.
2024/10/15Import · Class 1 Bepirovirsen 注射液 · No verified English nameJXHL2400246 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited
2024/10/15Import · Class 1 Daplusiran/Tomligisiran 注射液 · No verified English nameJXHL2400245 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited
2024/10/15Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2403475 Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Chongqing Lai Mei Pharma Co., Ltd. romanized
2024/10/15Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2403474 Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Chongqing Lai Mei Pharma Co., Ltd. romanized
2024/10/15Generic · Class 3 聚乙二醇3350散 · No verified English nameCYHS2403471 Ma Ying Long Pharma Group Co., Ltd. romanized
2024/10/15Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2403470 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2024/10/15Generic · Class 3 Oxacillin Sodium for InjectionCYHS2403469 Hunan Bai Qi He Drug Research and Development Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/10/15Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2403468 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2024/10/15Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2403464 Bai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanized; Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized
2024/10/15Generic · Class 3 Potassium Chloride Oral SolutionCYHS2403457 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Sui Cheng Pharma Co., Ltd. romanized
2024/10/15Generic · Class 3 Fudosteine oral solutionCYHS2403456 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2024/10/15Generic · Class 3 Fudosteine oral solutionCYHS2403455 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2024/10/15Generic · Class 3 Fudosteine oral solutionCYHS2403454 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2024/10/15Generic · Class 3 Sodium Bicarbonate InjectionCYHS2403453 Heilongjiang Sheng Zhi Run Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/10/15Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2403450 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/10/15Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2403449 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/10/15Generic · Class 3 Tartilelin TabletsCYHL2400200 Chengdu Jian Ze Pharmaceuticals Technology Co., Ltd. romanized
2024/10/15New drug · Class 2.2 注射用维迪西妥单抗 · No verified English nameCXSS2400111 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2024/10/15New drug · Class 1 YFQLXB-UC01注射液 · No verified English nameCXSL2400695 Shandong Sheng Qi Lu Xi Bao Zhi Liao Gong Cheng Technology Co., Ltd. romanized
2024/10/15New drug · Class 1 GNC-038四特异性抗体注射液 · No verified English nameCXSL2400694 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2024/10/15New drug · Class 1 GNC-038四特异性抗体注射液 · No verified English nameCXSL2400693 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2024/10/15New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2401081 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2024/10/15New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2401080 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2024/10/15New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2401079 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2024/10/15New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2401078 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2024/10/15New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2401077 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2024/10/15New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2401076 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2024/10/15New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2401075 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2024/10/15New drug · Class 1 TQH3906胶囊 · No verified English nameCXHL2401074 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized

131 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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