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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 367 drug applications between 22 October 2024 and 28 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 116, covering 80 drug names.

2024/10/22 – 2024/10/28

Period
2024/10/22 to 2024/10/28, 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
367
Drugs with new generic filings (by drug name, de-duplicated)
80
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

367filings, 116 of them generic

By application type

Application typeFilings
Supplement176
Generic116
New drug48
Import15
Unspecified10
Import re-registration2

By drug type

Drug typeFilings
Chemical drug236
TCM74
Therapeutic biologic41
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

80 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets6360
2Methotrexate Injection6111
3维生素B6注射液 · No verified English name4410
4Crisaborole Ointment2226
5Bilastine Oral Solution228
6氯化钙注射液 · No verified English name226
7Famotidine Injection228
8Landiolol Hydrochloride for Injection2219
9Lactulose Oral Solution2134
10Lactated Ringer's Injection215

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

219 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangdong Sunho Pharmaceutical Co., Ltd.24170
2Jilin Sheng Shang Cheng Pharma Co., Ltd. romanized980
3Shenyang Dong Xin Pharma Co., Ltd. romanized980
4Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized616
5Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized550
6Novo Nordisk A/S510
7Sanofi-Aventis Recherche & Développement440
8Hua Chuan Pharmaceutical Co., Ltd. romanized440
9Beijing Bai Yi Wu You Technology Development Co., Ltd. romanized430
10Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized434

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

114 this week

AcceptedDrugApplicants
2024/10/28Generic · Class 3 Sodium Lactate Ringer's Irrigation SolutionCYHS2403652 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/10/28Generic · Class 3 Pentoxifylline InjectionCYHS2403651 Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized
2024/10/28New drug · Class 3.3 帕妥珠单抗注射液 · No verified English nameCXSS2400116 Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized
2024/10/28New drug · Class 1 SYS6045 · No verified English nameCXSL2400733 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/10/28New drug · Class 1 1D228片 · No verified English nameCXHL2401138 Guangzhou Zhong Ke Lai En Drug Research Co., Ltd. romanized; Guangdong Lai En Pharmaceuticals Research Institute Co., Ltd. romanized
2024/10/28New drug · Class 2.3 SMF-213 · No verified English nameCXHL2401137 Jiangxi Shimei Pharmaceutical Co., Ltd
2024/10/28New drug · Class 1 伊匹乌肽雾化吸入溶液 · No verified English nameCXHL2401136 Yi Cheng Kang Tai (Xiamen) Bio Technology Co., Ltd. romanized
2024/10/28New drug · Class 1 SYH2051片 · No verified English nameCXHL2401135 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2024/10/28New drug · Class 1 SYH2051片 · No verified English nameCXHL2401134 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2024/10/26Import · Class 1 Remternetug注射液 · No verified English nameJXSL2400205 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/26Generic · Class 3 布比卡因脂质体注射液 · No verified English nameCYHS2403649 Zhejiang Sheng Zhao Drug Technology Co., Ltd. romanized; Hangzhou Ao Ya Bio Technology Co., Ltd. romanized
2024/10/26Generic · Class 3 布比卡因脂质体注射液 · No verified English nameCYHS2403648 Zhejiang Sheng Zhao Drug Technology Co., Ltd. romanized; Hangzhou Ao Ya Bio Technology Co., Ltd. romanized
2024/10/26Generic · Class 3 咪达唑仑口服溶液 · No verified English nameCYHS2403647 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2024/10/26Generic · Class 3 辅酶Q10片 · No verified English nameCYHS2403644 Chengdu Brilliant Pharmaceutical Co., Ltd.
2024/10/26Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2403638 Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2024/10/26Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2403635 Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/10/26New drug · Class 2.2 注射用泰它西普 · No verified English nameCXSS2400115 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2024/10/26New drug · Class 1 HB0028注射液 · No verified English nameCXSL2400732 Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/10/26New drug · Class 1 HB002.1T注射液 · No verified English nameCXSL2400731 Zhejiang Hua Hai Bio Technology Co., Ltd. romanized
2024/10/26New drug · Class 1 SHR-4375注射液 · No verified English nameCXSL2400730 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/10/26New drug · Class 1 MAX-10181片 · No verified English nameCXHL2401133 Beijing Zai Ji Pharmaceuticals Technology Co., Ltd. romanized
2024/10/26New drug · Class 1 MAX-10181片 · No verified English nameCXHL2401132 Beijing Zai Ji Pharmaceuticals Technology Co., Ltd. romanized
2024/10/26New drug · Class 1 MAX-10181片 · No verified English nameCXHL2401131 Beijing Zai Ji Pharmaceuticals Technology Co., Ltd. romanized
2024/10/25Import · Class 1 S095029 · No verified English nameJXSL2400204 Institut de Recherches Internationales Servier; Servier (Beijing) Pharmaceutical Research & Development Co. LTD
2024/10/25Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2400258 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2024/10/25Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2400257 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2024/10/25Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2403632 Shandong Qidu Pharmaceutical Co., Ltd.
2024/10/25Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2403631 Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized
2024/10/25Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2403629 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2024/10/25Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2403625 Xian An Jian Pharma Co., Ltd. romanized

84 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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