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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 360 drug applications between 15 October 2024 and 21 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 100, covering 77 drug names.

2024/10/15 – 2024/10/21

Period
2024/10/15 to 2024/10/21, 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
360
Drugs with new generic filings (by drug name, de-duplicated)
77
Accepted this week, now under review
3

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

360filings, 100 of them generic

By application type

Application typeFilings
Supplement139
Generic100
New drug81
Import25
Unspecified10
Import re-registration5

By drug type

Drug typeFilings
Chemical drug226
TCM64
Therapeutic biologic56
Biologic7
Prophylactic biologic7

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

77 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Bromhexine Hydrochloride Injection338
2Hydrocortisone Sodium Succinate for Injection3216
3匹伐他汀钙口崩片 · No verified English name310
4Fudosteine oral solution317
5Potassium Chloride Oral Solution2211
6Metoclopramide Hydrochloride Injection226
7聚乙二醇3350散 · No verified English name222
8Tacrolimus Sustained-release Capsules216
9复方电解质醋酸钠葡萄糖注射液 · No verified English name2122
10复方聚乙二醇(3350)电解质散 · No verified English name213

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

234 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1120
2Eli Lilly and Company720
3Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.710
4Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized660
5Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized660
6AstraZeneca AB530
7Name not romanized430
8Hainan Si Da Pharmaceutical Co., Ltd. romanized424
9Zhang Zhou Pian Zai Huang Pharma Co., Ltd. romanized420
10Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized410

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

145 this week

AcceptedDrugApplicants
2024/10/21New drug · Class 1 靶向CD19基因修饰的异体嵌合抗原受体T细胞注射液 · No verified English nameCXSL2400714 Shanghai Bang Yao Bio Technology Co., Ltd. romanized
2024/10/21New drug · Class 1 SYH2059片 · No verified English nameCXHL2401117 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/10/21New drug · Class 1 SYH2059片 · No verified English nameCXHL2401116 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/10/20Generic · Class 3 Potassium Chloride Oral SolutionCYHS2403542 Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Hang Kang Pharma Co., Ltd. romanized
2024/10/19New drug · Class 1 注射用ZG005 · No verified English nameCXSL2400713 Name not romanized; Name not romanized
2024/10/19New drug · Class 1 WJB001胶囊 · No verified English nameCXHL2401115 Wei Jing Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/10/19New drug · Class 1 WJB001胶囊 · No verified English nameCXHL2401114 Wei Jing Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/10/19New drug · Class 1 ART101注射液 · No verified English nameCXHL2401113 Suzhou Ang Tuo Biopharmaceuticals Co., Ltd. romanized
2024/10/19New drug · Class 1 AK-1286片 · No verified English nameCXHL2401112 Shanghai Ying Li Pharma Co., Ltd. romanized
2024/10/19New drug · Class 1 AK-1286片 · No verified English nameCXHL2401111 Shanghai Ying Li Pharma Co., Ltd. romanized
2024/10/19New drug · Class 1 LKR202注射液 · No verified English nameCXHL2401110 Shanghai Li Kang Rui Bio Gong Cheng Co., Ltd. romanized; Shanghai Hao Hai Bio Technology Co., Ltd. romanized
2024/10/19New drug · Class 1 盐酸吉卡昔替尼片 · No verified English nameCXHL2401109 Name not romanized; Name not romanized
2024/10/18Import · Class 3.1 Tremelimumab注射液 · No verified English nameJXSS2400099 AstraZeneca AB; Vetter Pharma-Fertigung GmbH & Co. KG; AstraZeneca Global R&D (China) Co. Ltd.
2024/10/18Import · Class 3.1 度伐利尤单抗注射液 · No verified English nameJXSS2400098 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2024/10/18Import · Class 3.1 Tremelimumab注射液 · No verified English nameJXSS2400097 AstraZeneca AB; Vetter Pharma-Fertigung GmbH & Co. KG; AstraZeneca Global R&D (China) Co. Ltd.
2024/10/18Import · Class 3.1 度伐利尤单抗注射液 · No verified English nameJXSS2400096 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2024/10/18Import · Class 2.2 Dostarlimab注射液 · No verified English nameJXSL2400197 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2024/10/18Import · Class 1 Belrestotug注射液 · No verified English nameJXSL2400196 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited
2024/10/18Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400254 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/18Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400253 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/18Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400252 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/18Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400251 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/18Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400250 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/18Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400249 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/18Generic · Class 3 Medium and Long Chain Fat Emulsion,Amino Acids(16)and Glucose(36%) InjectionCYHS2403541 Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/10/18Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2403540 Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/10/18Generic · Class 3 碳酸氢钠林格注射液(Ⅰ) · No verified English nameCYHS2403539 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2024/10/18Generic · Class 3 匹伐他汀钙口崩片 · No verified English nameCYHS2403538 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2024/10/18Generic · Class 3 匹伐他汀钙口崩片 · No verified English nameCYHS2403537 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2024/10/18Generic · Class 3 匹伐他汀钙口崩片 · No verified English nameCYHS2403536 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized

115 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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