YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 515 drug applications between 10 September 2024 and 16 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 150, covering 106 drug names.
2024/09/10 – 2024/09/16
- New acceptances this week
- 515
- Drugs with new generic filings (by drug name, de-duplicated)
- 106
- Accepted this week, now under review
- 10
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
515filings, 150 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 250 |
| Generic | 150 |
| New drug | 91 |
| Import | 16 |
| Import re-registration | 5 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 374 |
| TCM | 71 |
| Therapeutic biologic | 62 |
| Prophylactic biologic | 6 |
| In vitro diagnostic reagent | 1 |
| Biologic | 1 |
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
106 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Brexpiprazole Tablets | 6 | 2 | 31 |
| 2 | Levocetirizine dihydrochloride Oral Solution | 5 | 2 | 5 |
| 3 | Ipratropium Bromide Inhalation Solution | 4 | 2 | 2 |
| 4 | Minoxidil Liniment | 4 | 2 | 52 |
| 5 | Lactulose Oral Solution | 3 | 2 | 34 |
| 6 | Trazodone Hydrochloride Tablets | 3 | 2 | 5 |
| 7 | Sodium Bicarbonate Injection | 3 | 2 | 10 |
| 8 | 注射用头孢唑肟钠 · No verified English name | 3 | 1 | 4 |
| 9 | Nicardipine Hydrochloride Injection | 3 | 1 | 13 |
| 10 | Acetylcysteine Solution For Inhalation | 2 | 2 | 4 |
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
282 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Xin Wan Lian Pharmaceuticals Co., Ltd. romanized | 49 | 48 | 0 |
| 2 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized | 10 | 3 | 0 |
| 3 | Qilu Pharmaceutical Co., Ltd. | 8 | 3 | 0 |
| 4 | Gan Li Pharma Shandong Co., Ltd. romanized | 8 | 1 | 0 |
| 5 | Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 6 | 3 | 6 |
| 7 | Celgene Corporation | 6 | 1 | 0 |
| 8 | Suzhou Pai Rui Bio Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | AstraZeneca AB | 5 | 3 | 0 |
| 10 | Pfizer Europe MA EEIG | 5 | 3 | 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
165 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/15Import · Class 1 | DS-1062a · No verified English nameJXSL2400171 | ASTRAZENECA AB; AstraZeneca Investment (China) Co. Limited |
| 2024/09/15Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHS2400068 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/09/15Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHS2400067 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/09/15Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHS2400066 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/09/15Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHS2400065 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/09/15Generic · Class 3 | 碳酸氢钠林格注射液(I) · No verified English nameCYHS2403111 | Zhejiang Kang Ji Er Pharma Co., Ltd. romanized |
| 2024/09/15Generic · Class 3 | Compound Paracetamol and Vitamin C Effervescent TabletsCYHS2403104 | Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized |
| 2024/09/15New drug · Class 1.2 | 复制缺陷型猴痘疫苗 · No verified English nameCXSL2400627 | Beijing Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2024/09/15New drug · Class 1 | 注射用BG-C477 · No verified English nameCXSL2400626 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2024/09/15New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHS2400095 | Qilu Pharmaceutical Co., Ltd. |
| 2024/09/15New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHS2400094 | Qilu Pharmaceutical Co., Ltd. |
| 2024/09/15New drug · Class 2.4 | Remimazolam Besylate For InjectionCXHS2400093 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2024/09/15New drug · Class 2.4 | Remimazolam Besylate For InjectionCXHS2400092 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2024/09/15New drug · Class 1 | CMS-D005注射液 · No verified English nameCXHL2400975 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized |
| 2024/09/15New drug · Class 1 | CMS-D005注射液 · No verified English nameCXHL2400974 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized |
| 2024/09/14Import · Class 1 | AZD2936 · No verified English nameJXSL2400170 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/14Import · Class 2.2 | 度普利尤单抗注射液 · No verified English nameJXSL2400169 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2024/09/14Import · Class 1 | AZD0486 · No verified English nameJXSL2400168 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/14Import · Class 1 | DS-6000a · No verified English nameJXSL2400167 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2024/09/14Import · Class 1 | AZD5462片 · No verified English nameJXHL2400218 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/14Import · Class 1 | AZD5462片 · No verified English nameJXHL2400217 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/14Generic · Class 3 | Fat-Soluble Vitamin Injection(Ⅱ)CYHS2403099 | Shenyang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2024/09/14Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2403098 | Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2024/09/14Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2403094 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2024/09/14Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2403093 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2024/09/14Generic · Class 3 | Levofolinate Calcium for InjectionCYHS2403091 | Anhui Pioneer Pharmaceutical Co., Ltd |
| 2024/09/14Generic · Class 3 | Ephedrine Sulfate InjectionCYHS2403085 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. |
| 2024/09/14Generic · Class 3 | Magnesium Sulfate InjectionCYHS2403083 | Guo Yao Group Guo Rui Pharma Co., Ltd. romanized |
| 2024/09/14Generic · Class 3 | Alendronate Sodium Oral SolutionCYHS2403082 | Wuhan Hua Er Bio Technology Co., Ltd. romanized; Hubei Duo Rui Pharma Co., Ltd. romanized |
| 2024/09/14Generic · Class 3 | Minoxidil LinimentCYHS2403080 | Man Xiu Lei Dun (Zhongguo) Pharma Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
135 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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