YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 329 drug applications between 27 June 2024 and 3 July 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 66 drug names.
2024/06/27 – 2024/07/03
- New acceptances this week
- 329
- Drugs with new generic filings (by drug name, de-duplicated)
- 66
- Accepted this week, now under review
- 5
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
329filings, 90 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 177 |
| Generic | 90 |
| New drug | 34 |
| Import | 13 |
| Import re-registration | 12 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 235 |
| TCM | 55 |
| Therapeutic biologic | 33 |
| Prophylactic biologic | 6 |
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
66 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Bumetanide Injection | 4 | 3 | 13 |
| 2 | Calcium Folinate Injection | 2 | 2 | 4 |
| 3 | Epalrestat Tablets | 2 | 2 | 1 |
| 4 | Ibuprofen Suspension | 2 | 2 | 14 |
| 5 | Penehyclidine Hydrochloride Injection | 2 | 2 | 2 |
| 6 | 盐酸阿莫罗芬搽剂 · No verified English name | 2 | 2 | 15 |
| 7 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
| 8 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 9 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 10 | Diquafosol Sodium Eye Drops | 2 | 1 | 5 |
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
198 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Luo Yang Hao Long Pharma Co., Ltd. romanized | 17 | 8 | 0 |
| 2 | Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized | 10 | 10 | 0 |
| 3 | AstraZeneca AB | 6 | 3 | 0 |
| 4 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 5 | Ha Yao Group Pharmaceutical Factory romanized | 5 | 3 | 0 |
| 6 | Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized | 4 | 4 | 0 |
| 7 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 8 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Ren He Yi Kang Group Co., Ltd. romanized | 4 | 2 | 2 |
| 10 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 4 | 1 | 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
83 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/07/03Import · Class 2.1; 2.2 | 古塞奇尤单抗注射液(静脉输注) · No verified English nameJXSS2400054 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2024/07/03Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSS2400053 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2024/07/03Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSS2400052 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2024/07/03Import · Class 1 | VGX-3100 · No verified English nameJXSL2400119 | Inovio Pharmaceuticals Inc.; Beijing Apollo Saturn Biological Technology Limited |
| 2024/07/03Import · Class 2.4 | 注射用68Ga-PSMA-11 · No verified English nameJXHL2400154 | Telix Pharmaceuticals (US) Inc.; Grand Pharmaceutical (China) Co. Ltd. |
| 2024/07/03Generic · Class 3 | Tofacitinib Citrate Oral SolutionCYHS2402004 | Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized |
| 2024/07/03Generic · Class 3 | Tofacitinib Citrate Oral SolutionCYHS2402003 | Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized |
| 2024/07/03Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2402002 | Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized |
| 2024/07/03Generic · Class 3 | Epalrestat TabletsCYHS2402001 | Shijiazhuang Kang Li Pharma Co., Ltd. romanized |
| 2024/07/03Generic · Class 3 | Thiotepa for InjectionCYHS2402000 | Heilongjiang Fu He Pharmaceutical Group Co., Ltd. romanized |
| 2024/07/03Generic · Class 3 | Potassium Phosphates InjectionCYHS2401998 | Yi Yao Tong (Hebei) Bio Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized |
| 2024/07/03Generic · Class 3 | Epalrestat TabletsCYHS2401994 | Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized |
| 2024/07/03Generic · Class 3 | 布比卡因脂质体注射液 · No verified English nameCYHS2401989 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/07/03New drug · Class 1 | Obexelimab注射液 · No verified English nameCXSL2400423 | Shanghai Ze Na Shi Bio Technology Co., Ltd. romanized |
| 2024/07/03New drug · Class 1 | LTC004 · No verified English nameCXSL2400422 | Beijing Zhi Dao Bio Technology Co., Ltd. romanized |
| 2024/07/02Import · Class 1 | AMG 451 · No verified English nameJXSL2400118 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2024/07/02Import · Class 1 | AZD0780薄膜衣片 · No verified English nameJXHL2400151 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/07/02Generic · Class 3 | 碳酸氢钠血滤置换液(钾4mmol/L) · No verified English nameCYHS2401981 | Shanghai Feng Lin Bio Technology Co., Ltd. romanized; Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2024/07/02Generic · Class 3 | Obeticholic Acid TabletsCYHS2401974 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2024/07/02Generic · Class 3 | Obeticholic Acid TabletsCYHS2401973 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2024/07/02Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2401972 | Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized |
| 2024/07/02Generic · Class 3 | Vitamin K1 InjectionCYHS2401970 | Hainan Hua Yi Pharma Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized |
| 2024/07/02Generic · Class 3 | Potassium Chloride GranulesCYHS2401968 | Zhuo Zhou Dong Le Pharmaceutical Co., Ltd. romanized |
| 2024/07/02Generic · Class 3 | Potassium Chloride GranulesCYHS2401967 | Zhuo Zhou Dong Le Pharmaceutical Co., Ltd. romanized |
| 2024/07/02Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2401966 | Zhejiang Kai Run Pharma Co., Ltd. romanized |
| 2024/07/02Generic · Class 3 | Sulpiride InjectionCYHS2401964 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2024/07/02Generic · Class 3 | Allopurinol TabletsCYHS2401963 | Jiangsu Deyuan Pharmaceutical Co.,Ltd. |
| 2024/07/02New drug · Class 1.1 | 艾康片 · No verified English nameCXZL2400037 | An Hua Heng Tai (Beijing) Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/07/02New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2400421 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2024/07/02New drug · Class 1 | KYS202004A注射液 · No verified English nameCXSL2400420 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
53 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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