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
- 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 type | Filings |
|---|---|
| Supplement | 236 |
| Generic | 160 |
| New drug | 95 |
| Import | 37 |
| Unspecified | 15 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 359 |
| TCM | 102 |
| Therapeutic biologic | 76 |
| Biologic | 9 |
| Prophylactic biologic | 7 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Bromhexine Hydrochloride Injection | 3 | 3 | 8 |
| 2 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 3 | 3 | 8 |
| 3 | Hydrocortisone Sodium Succinate for Injection | 3 | 2 | 16 |
| 4 | 匹伐他汀钙口崩片 · No verified English name | 3 | 1 | 0 |
| 5 | Fudosteine oral solution | 3 | 1 | 7 |
| 6 | Dasatinib Tablets | 3 | 1 | 4 |
| 7 | Pediatric Faropenem Sodium Granules | 2 | 2 | 2 |
| 8 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 9 | 聚乙二醇3350散 · No verified English name | 2 | 2 | 2 |
| 10 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
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) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 11 | 2 | 0 |
| 2 | Guizhou Ke Lun Pharma Co., Ltd. romanized | 9 | 3 | 1 |
| 3 | Bristol-Myers Squibb Pharma EEIG | 7 | 3 | 0 |
| 4 | Eli Lilly and Company | 7 | 2 | 0 |
| 5 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 7 | 1 | 0 |
| 6 | Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 8 | AstraZeneca AB | 6 | 4 | 0 |
| 9 | Janssen-Cilag International NV | 6 | 4 | 0 |
| 10 | Jiangsu Shen Hua Pharma Co., Ltd. romanized | 5 | 5 | 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
192 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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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