YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 352 drug applications between 30 August 2024 and 5 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 115, covering 81 drug names.
2024/08/30 – 2024/09/05
- New acceptances this week
- 352
- Drugs with new generic filings (by drug name, de-duplicated)
- 81
- Accepted this week, now under review
- 2
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
352filings, 115 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 148 |
| Generic | 115 |
| New drug | 55 |
| Import | 21 |
| Import re-registration | 9 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 238 |
| TCM | 61 |
| Therapeutic biologic | 47 |
| 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
81 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 5 | 2 | 23 |
| 2 | Rivaroxaban Tablets | 4 | 1 | 3 |
| 3 | 氯化钙注射液 · No verified English name | 3 | 3 | 6 |
| 4 | 维生素B6注射液 · No verified English name | 3 | 3 | 10 |
| 5 | Dapoxetine Hydrochloride Tablets | 3 | 2 | 20 |
| 6 | Gadobutrol Injection | 3 | 1 | 8 |
| 7 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English name | 2 | 2 | 7 |
| 8 | Formoterol Fumarate Inhalation Solution | 2 | 2 | 5 |
| 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
222 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 11 | 11 | 0 |
| 2 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized | 5 | 3 | 5 |
| 4 | AstraZeneca AB | 5 | 2 | 0 |
| 5 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 6 | Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 4 |
| 7 | Qingdao Dong Hai Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Janssen-Cilag International NV | 4 | 2 | 0 |
| 9 | Novartis Pharma Schweiz AG | 4 | 2 | 0 |
| 10 | ASPEN PHARMA TRADING LIMITED | 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
108 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/05Import · Class 3.1 | 帕西生长素注射液 · No verified English nameJXSS2400074 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2024/09/05Import · Class 3.1 | 帕西生长素注射液 · No verified English nameJXSS2400073 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2024/09/05Import · Class 2.2 | 格菲妥单抗注射液 · No verified English nameJXSS2400072 | Roche Pharma (Schweiz) AG; Genentech Inc.; Roche (China) Holding Ltd. |
| 2024/09/05Import · Class 1 | AZD0486 · No verified English nameJXSL2400163 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/05Import · Class 1 | AZD0486 · No verified English nameJXSL2400162 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/05Import · Class 2.4 | 盐酸伊普可泮胶囊 · No verified English nameJXHS2400061 | Novartis Pharma Schweiz AG; Novartis Pharma Produktions GmbH |
| 2024/09/05Generic · Class 3 | Carbazochrome Sodium Sulfonate TabletsCYHS2402929 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2024/09/05Generic · Class 3 | Carbazochrome Sodium Sulfonate TabletsCYHS2402928 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2024/09/05Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2402925 | Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized |
| 2024/09/05Generic · Class 3 | 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2402919 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2024/09/05Generic · Class 3 | 维生素B?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2402915 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/09/05New drug · Class 2.2 | 恩朗苏拜单抗注射液 · No verified English nameCXSL2400595 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2024/09/05New drug · Class 1 | SHR-1819注射液 · No verified English nameCXSL2400594 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/09/05New drug · Class 1 | 注射用SHR-1501 · No verified English nameCXSL2400593 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/09/05New drug · Class 1 | 注射用MHB118C · No verified English nameCXSL2400592 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2024/09/05New drug · Class 1 | 注射用SKB571 · No verified English nameCXSL2400591 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2024/09/05New drug · Class 1 | 硫酸艾玛昔替尼片 · No verified English nameCXHS2400089 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/09/05New drug · Class 1 | PE-003片 · No verified English nameCXHL2400912 | Yuan Yan Gang Sheng Ming Ke Xue (Shanghai) Co., Ltd. romanized; Yuan Yan Yao Gang Sheng Ming Ke Xue (Liaoning) Group Co., Ltd. romanized |
| 2024/09/05New drug · Class 1 | PE-003片 · No verified English nameCXHL2400911 | Yuan Yan Gang Sheng Ming Ke Xue (Shanghai) Co., Ltd. romanized; Yuan Yan Yao Gang Sheng Ming Ke Xue (Liaoning) Group Co., Ltd. romanized |
| 2024/09/05New drug · Class 1 | 伊匹乌肽滴眼液 · No verified English nameCXHL2400910 | Guangzhou Yi Ming Kang Bio Technology Co., Ltd. romanized |
| 2024/09/05New drug · Class 2.4 | 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2400909 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2024/09/04Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSS2400071 | Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2024/09/04Import · Class 1 | BI 765179 注射用粉末 · No verified English nameJXSL2400161 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2024/09/04Import · Class 1 | AZD8630 · No verified English nameJXSL2400160 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/04Import · Class 1 | AZD8630 · No verified English nameJXSL2400159 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/04Import · Class 1 | AZD8630 · No verified English nameJXSL2400158 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/04Import · Class 1 | Lunsekimig注射液 · No verified English nameJXSL2400157 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2024/09/04Import · Class 2.4 | Atogepant Tablets · No verified English nameJXHL2400215 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/09/04Import · Class 1 | AZD5004薄膜包衣片 · No verified English nameJXHL2400214 | Eccogene Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/04Import · Class 1 | AZD5004薄膜包衣片 · No verified English nameJXHL2400213 | Eccogene Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
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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