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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 553 drug applications between 12 October 2024 and 18 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 160, covering 123 drug names.

2024/10/12 – 2024/10/18

Period
2024/10/12 to 2024/10/18, 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
553
Drugs with new generic filings (by drug name, de-duplicated)
123
Accepted this week, now under review
4

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

553filings, 160 of them generic

By application type

Application typeFilings
Supplement236
Generic160
New drug95
Import37
Unspecified15
Import re-registration10

By drug type

Drug typeFilings
Chemical drug359
TCM102
Therapeutic biologic76
Biologic9
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

123 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Bromhexine Hydrochloride Injection338
2Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution338
3Hydrocortisone Sodium Succinate for Injection3216
4匹伐他汀钙口崩片 · No verified English name310
5Fudosteine oral solution317
6Dasatinib Tablets314
7Pediatric Faropenem Sodium Granules222
8Metoclopramide Hydrochloride Injection226
9聚乙二醇3350散 · No verified English name222
10Tacrolimus Sustained-release Capsules216

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

342 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1120
2Guizhou Ke Lun Pharma Co., Ltd. romanized931
3Bristol-Myers Squibb Pharma EEIG730
4Eli Lilly and Company720
5Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.710
6Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized660
7Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized660
8AstraZeneca AB640
9Janssen-Cilag International NV640
10Jiangsu Shen Hua Pharma Co., Ltd. romanized550

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

192 this week

AcceptedDrugApplicants
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
2024/10/18Generic · Class 3 Sucralfate Oral SuspensionCYHS2403535 Jinan Tong Lu Pharmaceuticals Technology Development Co., Ltd. romanized; Guangxi Nanning Bai Hui Pharma Group Co., Ltd. romanized
2024/10/18Generic · Class 3 Bumetanide InjectionCYHS2403533 CISEN PHARMACEUTICAL CO., LTD.
2024/10/18Generic · Class 3 Sodium Bicarbonate Ringer’s InjectionCYHS2403529 Sichuan Tai Ping Yang Pharma Co., Ltd. romanized
2024/10/18Generic · Class 3 聚乙二醇3350散 · No verified English nameCYHS2403528 Zhejiang Yuan Li Jian Pharma Co., Ltd. romanized
2024/10/18Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2403526 Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized
2024/10/18Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2403525 Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2024/10/18Generic · Class 3 尿素[13C]片呼气试验药盒 · No verified English nameCYHL2400204 Chengdu Brilliant Pharmaceutical Co., Ltd.
2024/10/18New drug · Class 3.3 冻干人用狂犬病疫苗(鸡胚成纤维细胞) · No verified English nameCXSS2400113 Shanghai Qing Sai Bio Technology Co., Ltd. romanized
2024/10/18New drug · Class 1 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2400712 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2024/10/18New drug · Class 1.3 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2400711 Yi Dao Bio Technology (Suzhou) Co., Ltd. romanized
2024/10/18New drug · Class 1 TJ037130注射液 · No verified English nameCXSL2400710 Tian Jing Bio Technology (Hangzhou) Co., Ltd. romanized
2024/10/18New drug · Class 1 GSK4381562A注射液 · No verified English nameCXSL2400709 Ge Lan Su Shi Ke (Zhongguo) Investment Co., Ltd. romanized

162 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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