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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 469 drug applications between 8 July 2025 and 14 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 128, covering 84 drug names.

2025/07/08 – 2025/07/14

Period
2025/07/08 to 2025/07/14, 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
469
Drugs with new generic filings (by drug name, de-duplicated)
84
Accepted this week, now under review
102

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

469filings, 128 of them generic

By application type

Application typeFilings
Supplement192
Generic128
New drug107
Import30
Import re-registration10
Unspecified2

By drug type

Drug typeFilings
Chemical drug318
TCM79
Therapeutic biologic68
Biologic2
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

84 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Empagliflozin Tablets6318
2瑞维那新吸入溶液 · No verified English name5553
3复方电解质醋酸钠葡萄糖注射液 · No verified English name4222
4Minoxidil Liniment4252
5Quetiapine Fumarate Extended-release Tablets410
6Guanfacine Hydrochloride Extended Release Tablets414
7Bilastine Oral Solution228
8Iguratimod Tablets2223
9Ilaprazole Enteric-coated Tablets2226
10醋酸钠林格葡萄糖注射液(Ⅰ) · No verified English name222

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

275 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized17140
2Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized940
3Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized860
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized820
5Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.755
6Sichuan Qing Shan Li Kang Pharma Co., Ltd. romanized747
7Eli Lilly and Company720
8AstraZeneca AB630
9Celgene Corporation610
10Suzhou Sheng Di Ya Biopharmaceuticals 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

183 this week

AcceptedDrugApplicants
2025/07/14Import · Class 1 IcoSema 注射液 · No verified English nameJXSL2500122 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2025/07/14Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2502518 TC Pharmaceuticals (Jiangsu) Co., Ltd
2025/07/14New drug · Class 2.2 恩朗苏拜单抗注射液 · No verified English nameCXSL2500588 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/07/14New drug · Class 2.2 QL2107注射液 · No verified English nameCXSL2500587 Qilu Pharmaceutical Co., Ltd.
2025/07/14New drug · Class 1 KDTV001注射液 · No verified English nameCXSL2500586 Wuhan Kai De Ji Nuo Bio Technology Co., Ltd. romanized
2025/07/14New drug · Class 1 注射用QLC5508 · No verified English nameCXSL2500585 Qilu Pharmaceutical Co., Ltd.
2025/07/14New drug · Class 1 EVM14注射液 · No verified English nameCXSL2500584 Yun Ding Xin Yao (Beijing) Pharmaceuticals Technology Co., Ltd. romanized
2025/07/14New drug · Class 2.3 BTP4507 · No verified English nameCXHL2500698 Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized
2025/07/12Import · Class 1 AZD5335 · No verified English nameJXSL2500121 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/12Import · Class 2.4 Sulfur Hexafluoride Microbubbles for InjectionJXHL2500183 Bracco International B.V.; Bracco Imaging Medical Technologies (Shanghai) Co. Ltd
2025/07/12Import · Class 1 AZD9574 · No verified English nameJXHL2500182 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/12Import · Class 1 AZD9574 · No verified English nameJXHL2500181 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/12Import · Class 1 AZD9574 · No verified English nameJXHL2500180 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/12Import · Class 1 AZD9574 · No verified English nameJXHL2500179 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/12Generic · Class 3 盐酸西替利嗪干糖浆 · No verified English nameCYHS2502516 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized
2025/07/12Generic · Class 3 Cimetidine InjectionCYHS2502505 Sen Miao (Shandong) Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized
2025/07/12Generic · Class 3 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2502504 Shanghai Zhao Hui Pharma Co., Ltd. romanized
2025/07/12Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2502503 Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2025/07/12Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2502502 Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2025/07/12Generic · Class 3 Minoxidil LinimentCYHS2502500 Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized
2025/07/12Generic · Class 3 Minoxidil LinimentCYHS2502499 Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized
2025/07/12Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2502498 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2025/07/12Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2502497 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2025/07/12Generic · Class 3 碳酸氢钠林格注射液(Ⅰ) · No verified English nameCYHS2502496 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2025/07/12Generic · Class 3 Minoxidil LinimentCYHS2502494 Hubei Wu Shi Pharma Co., Ltd. romanized
2025/07/12Generic · Class 3 Minoxidil LinimentCYHS2502493 Hubei Wu Shi Pharma Co., Ltd. romanized
2025/07/12Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2502490 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanized
2025/07/12Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2502489 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanized
2025/07/12Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2502485 Beijing Han Mei Medicines Co., Ltd. romanized
2025/07/12Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2502484 Beijing Han Mei Medicines Co., Ltd. romanized

153 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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