YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 603 drug applications between 24 September 2024 and 30 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 189, covering 129 drug names.
2024/09/24 – 2024/09/30
- New acceptances this week
- 603
- Drugs with new generic filings (by drug name, de-duplicated)
- 129
- Accepted this week, now under review
- 13
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
603filings, 189 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 230 |
| Generic | 189 |
| New drug | 100 |
| Import | 44 |
| Unspecified | 28 |
| Import re-registration | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 392 |
| TCM | 94 |
| Therapeutic biologic | 87 |
| Biologic | 20 |
| Prophylactic biologic | 10 |
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
129 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Fentanyl Citrate Buccal Tablets | 6 | 1 | 0 |
| 2 | Cefoperazone Sodium and Sulbactam Sodium for Injection | 6 | 1 | 14 |
| 3 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 4 | Brexpiprazole Tablets | 4 | 2 | 31 |
| 5 | Gadobutrol Injection | 4 | 1 | 8 |
| 6 | Polymyxin B sulfate for Injection | 3 | 3 | 6 |
| 7 | Dapagliflozin Tablets | 3 | 2 | 84 |
| 8 | Carbamazepine Sustained-Release Tablets(II) | 3 | 1 | 0 |
| 9 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 10 | Erythromycin Lactobionate for Injection | 3 | 1 | 13 |
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
356 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 10 | 3 | 0 |
| 2 | Novo Nordisk A/S | 9 | 5 | 0 |
| 3 | AstraZeneca AB | 9 | 4 | 0 |
| 4 | Amgen Inc. | 9 | 2 | 0 |
| 5 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 9 | 2 | 9 |
| 6 | Janssen-Cilag International NV | 7 | 3 | 0 |
| 7 | Guo Yao Group Kunming Xue Ye Zhi Pin Co., Ltd. romanized | 7 | 3 | 0 |
| 8 | Boehringer Ingelheim International GmbH | 7 | 1 | 0 |
| 9 | Zhejiang Wo Wu Bio Technology Co., Ltd. romanized | 7 | 1 | 0 |
| 10 | Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanized | 6 | 6 | 0 |
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
226 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/30Import · Class 2.2 | Dostarlimab注射液 · No verified English nameJXSL2400189 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2024/09/30Import · Class 1 | Belrestotug注射液 · No verified English nameJXSL2400188 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2024/09/30Import · Class 1 | MEDI5752 · No verified English nameJXSL2400187 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/30Import · Class 1 | DD01注射液 · No verified English nameJXHL2400241 | Neuraly Inc.; SHENZHEN SALUBRIS PHARMACEUTICALS CO. LTD. |
| 2024/09/30Generic · Class 3 | Pentoxifylline Modified Release TabletsCYHS2403327 | Jiangsu Hui Ju Pharma Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2024/09/30Generic · Class 3 | Acetylcysteine TabletsCYHS2403323 | Beijing Foyou Pharma CO.,LTD |
| 2024/09/30Generic · Class 3 | Bilastine Oral SolutionCYHS2403320 | Hefei Hua Wei Pharma Co., Ltd. romanized |
| 2024/09/30Generic · Class 3 | Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2403319 | Beijing SL Pharmaceutical Co., Ltd. |
| 2024/09/30Generic · Class 3 | Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2403318 | Beijing SL Pharmaceutical Co., Ltd. |
| 2024/09/30Generic · Class 3 | Propafenone Hydrochloride InjectionCYHS2403313 | Zai Wei Pharma (Hainan) Co., Ltd. romanized; Hainan Tong Yong San Yang Pharma Co., Ltd. romanized |
| 2024/09/30Generic · Class 3 | Isoniazid InjectionCYHS2403311 | Hebei Sai Pu Yi Hui Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2024/09/30Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2403306 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized |
| 2024/09/30Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2403305 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized |
| 2024/09/30Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2403304 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized |
| 2024/09/30Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2403302 | Yue Kang Pharma Group Co., Ltd. romanized |
| 2024/09/30Generic · Class 3 | Multiple Electrolyte Additive For InjectionCYHS2403301 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2024/09/30Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2403300 | Chengdu Ming De Zhi Yuan Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2024/09/30Generic · Class 3 | 盐酸羟甲唑啉滴鼻液 · No verified English nameCYHS2403299 | Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Nanjing Hai Jing Pharma Co., Ltd. romanized |
| 2024/09/30Generic · Class 3 | Acetazolamide Extended-release CapsulesCYHS2403298 | Henan Zhong Shuai Pharmaceuticals Technology Co., Ltd. romanized; Henan Zhong Shuai Pharma Co., Ltd. romanized |
| 2024/09/30Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHL2400199 | Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/30New drug · Class 1.1 | 连花御屏颗粒 · No verified English nameCXZL2400063 | Beijing Yi Ling Pharma Co., Ltd. romanized |
| 2024/09/30New drug · Class 1.1 | 藤参降压颗粒 · No verified English nameCXZL2400062 | Shandong Gu Jin Zhong Pharmaceuticals Technology Co., Ltd. romanized; Shandong Zhong Pharmaceuticals University Fu Shu Hospital romanized |
| 2024/09/30New drug · Class 3.3 | 四价流感病毒裂解疫苗 · No verified English nameCXSS2400106 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2024/09/30New drug · Class 2.2 | 培集成干扰素α-2注射液 · No verified English nameCXSS2400105 | Beijing Kai Yin Technology Co., Ltd. romanized |
| 2024/09/30New drug · Class 1.2 | 冻干带状疱疹病毒mRNA疫苗 · No verified English nameCXSL2400675 | Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized |
| 2024/09/30New drug · Class 2.2 | 盐酸奥洛他定口服溶液 · No verified English nameCXHS2400101 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2024/09/30New drug · Class 2.2 | 盐酸奥洛他定口服溶液 · No verified English nameCXHS2400100 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2024/09/30New drug · Class 1 | BGB-53038胶囊 · No verified English nameCXHL2401031 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/09/30New drug · Class 1 | BGB-53038胶囊 · No verified English nameCXHL2401030 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/09/30New drug · Class 1 | BGB-53038胶囊 · No verified English nameCXHL2401029 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
196 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.