YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 336 drug applications between 4 September 2024 and 10 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 106, covering 76 drug names.
2024/09/04 – 2024/09/10
- New acceptances this week
- 336
- Drugs with new generic filings (by drug name, de-duplicated)
- 76
- 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
336filings, 106 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 142 |
| Generic | 106 |
| New drug | 57 |
| Import | 18 |
| Import re-registration | 10 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 222 |
| TCM | 66 |
| Therapeutic biologic | 43 |
| Prophylactic biologic | 4 |
| 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
76 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sodium Hyaluronate Eye Drops | 3 | 2 | 30 |
| 2 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 3 | Erythromycin Lactobionate for Injection | 3 | 1 | 13 |
| 4 | Acetylcysteine Solution For Inhalation | 2 | 2 | 4 |
| 5 | Levocarnitine Injection | 2 | 2 | 4 |
| 6 | Bilastine Tablets | 2 | 2 | 7 |
| 7 | Tranexamic Acid Tablets | 2 | 2 | 9 |
| 8 | 氯化钙注射液 · No verified English name | 2 | 2 | 6 |
| 9 | Nicardipine Hydrochloride Injection | 2 | 2 | 13 |
| 10 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
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
213 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 9 | 8 | 2 |
| 3 | Gan Li Pharma Shandong Co., Ltd. romanized | 8 | 1 | 0 |
| 4 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized | 5 | 3 | 5 |
| 5 | AstraZeneca AB | 5 | 2 | 0 |
| 6 | Hua Run Shuang He Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Anhui Pioneer Pharmaceutical Co., Ltd | 4 | 3 | 3 |
| 8 | Janssen-Cilag International NV | 4 | 2 | 0 |
| 9 | Novartis Pharma Schweiz AG | 4 | 2 | 0 |
| 10 | Ren He Yi Kang Group Co., Ltd. romanized | 4 | 2 | 2 |
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
108 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/10Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2402992 | E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized |
| 2024/09/10Generic · Class 3 | Vardenafil Hydrochloride Orally disintegrating TabletsCYHS2402990 | Anhui Bei Ke Biopharmaceutical Co., Ltd. romanized |
| 2024/09/10Generic · Class 3 | Sulindac TabletsCYHS2402986 | Chengdu Tong De Pharma Co., Ltd. romanized |
| 2024/09/10Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2402980 | Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized |
| 2024/09/10Generic · Class 3 | Methotrexate TabletsCYHS2402978 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Shenzhen Wan Le Pharma Co., Ltd. romanized |
| 2024/09/10Generic · Class 3 | 托吡酯口服溶液 · No verified English nameCYHS2402975 | Ke Bei Yuan (Beijing) Pharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2024/09/10Generic · Class 3 | Cimetidine InjectionCYHS2402968 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized |
| 2024/09/10New drug · Class 1.1 | 芩葛退热解毒颗粒 · No verified English nameCXZL2400050 | Name not romanized |
| 2024/09/10New drug · Class 1 | GKL-006注射液 · No verified English nameCXSL2400602 | Beijing Ji Yin Qi Ming Bio Technology Co., Ltd. romanized |
| 2024/09/10New drug · Class 1 | 注射用SHR-4394 · No verified English nameCXSL2400601 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/09/10New drug · Class 1 | PJ016注射液 · No verified English nameCXSL2400600 | Chongqing Pai Jin Bio Technology Co., Ltd. romanized |
| 2024/09/10New drug · Class 1 | IN10018片 · No verified English nameCXHL2400938 | Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2024/09/10New drug · Class 1 | IN10018片 · No verified English nameCXHL2400937 | Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2024/09/10New drug · Class 1 | 注射用PL002 · No verified English nameCXHL2400936 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2024/09/10New drug · Class 1 | SS-001 软膏 · No verified English nameCXHL2400935 | Suzhou Pai Rui Bio Technology Co., Ltd. romanized |
| 2024/09/10New drug · Class 1 | SS-001 软膏 · No verified English nameCXHL2400934 | Suzhou Pai Rui Bio Technology Co., Ltd. romanized |
| 2024/09/10New drug · Class 1 | SS-001 软膏 · No verified English nameCXHL2400933 | Suzhou Pai Rui Bio Technology Co., Ltd. romanized |
| 2024/09/10New drug · Class 1 | BGB-58067片 · No verified English nameCXHL2400932 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/09/10New drug · Class 1 | BGB-58067片 · No verified English nameCXHL2400931 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/09/10New drug · Class 1 | GW117片 · No verified English nameCXHL2400930 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/10New drug · Class 1 | D-1553片 · No verified English nameCXHL2400929 | Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2024/09/10New drug · Class 2.2 | HY-2003 · No verified English nameCXHL2400928 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2024/09/09Generic · Class 3 | Vitamin K1 InjectionCYHS2402966 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/09/09Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2402965 | Haerbin Shi Kang Long Pharma Co., Ltd. romanized |
| 2024/09/09Generic · Class 3 | Trelagliptin Succinate TabletsCYHS2402964 | Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized |
| 2024/09/09Generic · Class 3 | Trelagliptin Succinate TabletsCYHS2402963 | Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized |
| 2024/09/07Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2402962 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2024/09/07Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2402961 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2024/09/07Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2402960 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2024/09/07Generic · Class 3 | 维生素B12注射液 · No verified English nameCYHS2402959 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
78 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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